StemCell Therapy

In rheumatoid arthritis patients in sustained remission on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs), continued csDMARD therapy with stable doses led to fewer disease activity flares and less frequent radiographic joint damage progression than tapered csDMARD treatment, according to a study presented at annual meeting of the American College of Rheumatology in Atlanta on November 12.

More patients with rheumatoid arthritis reach and maintain sustained remission on csDMARDs after the implementation of treat-to-target strategies. However, the knowledge about whether csDMARDs can be tapered in rheumatoid arthritis remission is limited.

The primary objective of the ARCTIC REWIND trial was to assess the effect of tapering of csDMARDs on the risk of flares in rheumatoid arthritis patients in sustained clinical remission.

In the trial, 155 rheumatoid arthritis patients (mean age 55 years) in clinical remission, as measured by the Disease Activity Score (DAS) for 44 joint counts, for at least 12 months on stable csDMARD therapy were randomly assigned to continued stable csDMARD (n=78, 64 percent female, 78.2 percent methotrexate monotherapy users) or half dose csDMARD (n=77, 69 percent female, 84.4 percent methotrexate monotherapy users), with visits every four months. The primary endpoint was the proportion of patients with a disease flare during the 12-month study period (a combination of DAS > 1.6, a change in DAS > 0.6 and at least two swollen joints, or both the physician and patient agreed that a clinically significant flare had occurred). Radiographic joint damage at baseline and 12 months was scored by van der Heijde modified Sharp score (progression: 1 unit change/year).

In an interview with Rheumatology Network, Siri Lillegraven, M.D., M.P.H, Ph.D., of Diakonhjemmet Hospital in Oslo, Norway, said the study aimed to include patients in deep remission, who had been in remission for at least a year. The study was designed as a non-inferiority study, based on the hypothesis that csDMARDs could be tapered in such a patient cohort. We were thus somewhat surprised by the clear difference in flare rates and by the difference in radiographic progression that was observed.

In the primary analysis, 6.4 percent of patients in the stable csDMARD group experienced a flare during the 12 months, compared to 24.7 percent in the half-dose csDMARD group, giving a risk difference (95% confidence interval [CI]) of 18.3 percent (7.2 percent to 29.3 percent). Non-inferiority, with a margin of 20 percent, could not be claimed.

In the stable group, 40 percent adjusted DMARD medication following the flares, compared to 94.7 percent in the half-dose group. No progression of radiographic joint damage was observed in 79.5 percent of patients on stable DMARDs and 62.7 percent in the half-dose group, difference (95% CI) -17.7 percent (-33 percent, -2.3 percent). At 12 months, 91.8 percent of patients in the stable arm and 85.1 percent of patients in the half-dose arm were in DAS remission, with similar results for other remission definitions.

A total of 75 and 53 adverse events occurred in the stable and tapered groups, respectively, with serious adverse events in 2.6 percent of patients in the stable group and in 5.1 percent, including two serious infections, of patients in the tapered group.

The results support that if a patient reaches sustained remission in RA on csDMARDs, flares are very rare if stable DMARD dose is continued, and that stable csDMARD therapy should be the preferred choice for these patients.

We find it interesting that very few disease activity flares occurred if patients in sustained remission received stable treatment, illustrating that the RA disease course can have a favorable outcome, even with the cheapest and globally most available DMARDs, Dr. Lillegraven said.

REFERENCE

LO8 - Tapering of Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis Patients in Sustained Remission: Results from a Randomized Controlled Trial. Siri Lillegraven, M.D., M.P.H, Ph.D., 9 a.m., Tuesday, Nov. 12. 2019 ACR/ARP Annual Meeting, Atlanta

More:
Conventional Therapy Bests Tapered Therapy in Rheumatoid Arthritis - Rheumatology Network

Racers of all ages will soon be gearing up in their favorite holiday costumes, along with lacing up their sneakers as they aim to cross the finish line during the Arthritis Foundations annual Jingle Bell Run on Saturday, December 7, at George M. Steinbrenner Field.

With this fundraising event, individuals can participate in the 5K untimed, 5K chip-timed, a Kids Run and a 1-Mile Fun Run or Walk. Besides the race, other festivities will also be available, such as entertainment, a kids zone, food and beverages and more.

Arthritis Foundation Development Director of Tampa Sherry Yagovane explained where 100 percent of these proceeds go to.

The funds raised will support our Live Yes! Network events, educational programs and send children to summer camp, Yagovane said. We also fund research for better treatments, cures and assist patients with access to treatments through advocacy on a state and federal level.

In 1948, the Arthritis Foundation became established. Arthritis, also known as joint disease or joint pain, can affect individuals of all ages. In fact, 300,000 children and more than 50 million Americans are diagnosed with it, according to the Arthritis Foundation. To add, arthritis is considered the leading cause of disability in America.

A couple of families shared how the Arthritis Foundation assisted them and their loved ones. For example, Tracey Corns two daughters suffer from rheumatoid arthritis. She also has volunteered with the Arthritis Foundation for more than 10 years.

This foundation means so much to our family as it provided educational resources and more, Corn said.

Carrie Shank also stated her appreciation for the foundation, as her daughter, Aubriana Gonzalez, has suffered from JIA (Juvenile Idiopathic Arthritis) since the age of 2. Gonzalez was selected to be this years Jingle Bell Run Youth Honoree.

I am passionate about this cause, and as a parent I do not feel alone on this journey with the foundation being such a great educational tool for myself, family and friends, Shank said.

To register for the walk, visit https://events.arthritis.org/index.cfm?fuseaction=donorDrive.event&eventID=930.

For more information, contact Yagovane at 467-7520.

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Upcoming Jingle Bell Run Benefits The Arthritis Foundation - Osprey Observer

Women with rheumatoid arthritis (RA) and other rheumatic conditions who want to breastfeed their newborns are generally able to so. Thats the finding from research presented at the 2019 annual meetingof the American College of Rheumatology in Atlanta on November 11, 2019.

Related: Can a Woman Who Has Rheumatoid Arthritis Have Kids?

Still, not every woman living with rheumatic disease with this desire does follow through, in some cases because of unfounded concerns about the safety of medicines they may be taking, says study coauthor Megan Clowse, MD, director of the Duke Autoimmunity in Pregnancy Clinic and associate professor of medicine at Duke University in Durham, North Carolina.

The good news is we found quite high levels of women desiring to breastfeed, and high numbers of those successfully doing so, Dr. Clowse says.

The 265 women in the study were part of a pregnancy registry Clowse set up for her practice a decade ago. There are a lot of women with rheumatic diseases who want to breastfeed, but there was very little data about this. When I set up the registry, I made sure we asked about breastfeeding, she says.

Related: People Living With Rheumatoid Arthritis Develop Resilience by Dealing With Disease Challenges

Before they delivered, 79 percent of the pregnant women indicated their desire to nurse. By the time of their postpartum visit an average of 7.5 weeks after delivering, three-quarters of these women were in fact doing so.

This means 25 percent of the women who had hoped to breastfeed were not. Some had tried but stopped, in some cases because they couldnt develop a milk supply or because their baby had health issues.

Other women said they gave up breastfeeding because they worried that the medicines they were taking might possibly pass through to the baby.

This mindset echoes the results of a survey conducted among members of the arthritis community CreakyJoints, presented at the American College of Rheumatology meeting in September 2017.

In that survey, 86 percent of women said they had either avoided taking medicines while breastfeeding, or they stopped nursing prematurely in order to resume the drugs needed to avoid postpartum flares.

Related: Rheumatoid Arthritis: Anatomy of a Flare

But for almost all rheumatoid arthritismedication, this concern is unfounded, Clowse says. New mothers can safely nurse on nearly all RA drugs in use today, she says.

Thats because medicines like Enbrel (etanercept) and Remicade (infliximab) dont readily pass to a baby through mothers milk, and any that do get through, especially with full-term infants, are not well absorbed by their gut, according to Mother to Baby, a website created by experts on birth defect risks.

Related: Rheumatoid Arthritis Medication

Clowse even tells patients they can nurse while taking methotrexate, a medicine that women must avoid while pregnant. Breastfeeding is a different biology from pregnancy. There is very minimal transfer in breast milk, she says.

The one type of medicine Clowse does restrict from nursing mothers is small-molecule Janus kinase (JAK) inhibitors, such as Xeljanz (tofacitinib), primarily because they are so new that there is not enough data on its nursing safety.

Clowse admits that she is especially enthusiastic about allowing patients to breastfeed, because she knows first hand that it can be an important part of a mothers experience.

Plus, breast milk is so healthy. According to the American College of Obstetricians and Gynecologists (ACOG), breast milk contains antibodies that protect infants from ear infections, diarrhea, respiratory illnesses, and allergies. It also can make it easier for moms to lose pregnancy weight, and it may reduce her risks of breast cancer and ovarian cancer. This is why ACOG recommends exclusive breastfeeding for the first 6 months of life, or longer if it is mutually desired by the mother and baby.

Related: How to Find a Rheumatologist

Clowse knows that her encouragement is likely more pronounced than that of other rheumatologists, and likely explains the high numbers she found in her study, she says.

In this research, women who exclusively formula-fed babies were likely to be younger and have less education and lower incomes than nursing mothers. Although black women in her study were less likely to nurse than whites, Clowse says that was related more to the education levels of the women in her registry than their race.

If your doctor erroneously tells you that you cannot nurse on any of the medicines you are taking, you can show them the information from Mother to Baby. Theres actual data, so you dont have to base the decision on myth, Clowse says.

The reality is you can breastfeed on almost all RA medication. You dont have to pick between taking care of your disease and breastfeeding your baby, she asserts.

Aimee Matsumoto, a public relations professional in Pasadena, California,who blogs about her experience having RA, is a new mom who is determined to nurse her infant. Matsumoto is not on any medicines, having had bad reactions to those she has previously tried.

Related: Home Remedies and Alternative Therapies for Rheumatoid Arthritis

Matsumoto was fortunate to go into remission during her pregnancy, but since her baby was born 9 months ago, her pain has come back with a vengeance. When her joints flare, it can be hard to breastfeed because of the challenges of holding the baby in a nursing position, she says.

Matsumoto overcomes this by using a nursing pillow, such as My Brest Friend, to take the weight off her hands. Other time she feeds her baby while both are lying down.

Related: Rheumatoid Arthritis: 20 Home Upgrades for Under $20

A lactation consultant is the best person to help you figure out ways you can nurse that protect your joints.

You can find one near you on the website of the International Lactation Consultant Association.

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Rheumatoid Arthritis and Breastfeeding: What Women With RA Need to Know - Everyday Health

Compared with seven other biologics and a phosphodiesterase-4 inhibitor, the anti-IL-12/23 biologic ustekinumab was associated with a generally lower risk of serious infection requiring hospitalization in patients with psoriasis or psoriatic arthritis, researchers reported on November 12 at the American College of Rheumatology annual meeting in Atlanta.

The study included 123,383 adults (mean age 48, 50% female) with psoriasis or psoriatic arthrits who started treatment with a biologic DMARD (ustekinumab, secukinumab, ixekizumab, or a TNFi (adalimumab, etanercept, infliximab, certolizumab, golimumab) or the oral phosphodiesterase inhibitorapremilast.

Of the patients included in the analysis, 61 percent had psoriasis, 22 percent had psoriatic arthritis and 17 percent had both."Of 123,383 PsO or PsA patients, ustekinumab initiators had a generally lower risk of hospitalized serious infection compared to TNFi, IL-17 therapy, and apremilast initiators," reported Seoyoung C. Kim, M.D., of Brigham and Womens Hospital, Boston. Hospitalized serious infections were highest in patients who were prescribed infliximab and lowest in those who received ixekizumab and ustekinumab.

Ultimately, ustekinumab had a lower risk of hospitalized serious infection compared to other bDMARDs or apremilast. However, how well ustekinumab performed as compared to certolizumab and golimumab could not be determined due to the small sample size.Overall, data was consistent across all eight agents, though statistically weaker for certolizumab and golimumab.

The primary outcome was a composite endpoint of hospitalized serious bacterial, viral, or opportunistic infection. Follow-up started the first day a drug was dispensed and ran until the outcome was met, the database ended, or a patient left the study, died, or discontinued or switched drugs.

Having rigorous real-world based safety data directly comparing several drugs with a similar clinical indication is important when discussing a treatment option with patients and making a better-informed medical decision, Dr. Kim reported.

REFERENCEL01 - Comparative Risk of Hospitalized Serious Infection in Patients with Psoriasis and Psoriatic Arthritis: A Population-Based Multi-Database Study, Seoyoung C. Kim, MD, ScD, MSCE, 9 a.m., Tuesday, Nov 12. American College of Rheumatology 2019 annual meeting, Atlanta.

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Ustekinumab Linked to Lower Serious Infection Rates in Psoriasis and Psoriatic Arthritis - Rheumatology Network

The company said its RA 360 solution will support employees to reduce or maintain their current level of drug use

eWellness Healthcare Corporation (), the pioneer in physical therapy telehealth treatments, announced Tuesday that it is developing a new rheumatoid arthritis treatment platform called RA360.

In a statement, the Culver City, California-based company, said the new platform is expected to be available in the first quarter of 2020.

Rheumatoid arthritis and related autoimmune disorders are the leading cause of illness and disability in the US.

In 2019, one in four Americans has arthritis, or one of its 100 related autoimmune disorders, according to the company.

Those with rheumatoid arthritis will need to go on disability or stop work entirely within 2 years of onset, the group added.

However, the company said that its innovative RA360 solution will support employees to reduce or maintain their current level of theraputic drug use.

The company notes that costs associated with arthritis hit $128 billion in 2005, while other studies put the cost closer to $353 billion when payouts, lost wages and other associated medical costs were stacked up.

According to eWellness Healthcare, a reduction in symptoms will alleviate stress on the health care system and the employer.

Arthritis isnt an individual problem, its everyones problem. The damage cannot be undone but can be managed, the company added, while making the case that its new rheumatoid arthritis treatment platform RA360 was part of the solution.

eWellness Healthcare is the first physical therapy telehealth company to offer real-time distance monitored assessments and treatments.

Contact Uttara Choudhury at[emailprotected]

Follow her onTwitter:@UttaraProactive

Continued here:
eWellness Healthcare developing new rheumatoid arthritis treatment platform RA360 - Proactive Investors USA & Canada

BACKGROUND:

Recent studies have demonstrated patients with rheumatoid arthritis (RA) have deranged coagulation parameters predisposing them to venous thromboembolisms (VTEs). Therefore, the purpose of this study was to investigate whether patients who have RA undergoing primary TKA have higher rates of (1) VTEs; (2) readmission rates; and (3) costs of care.

Patients who have RA undergoing primary TKA were identified and matched to controls in a 1:5 ratio by age, sex, and comorbidities. Exclusions included patients with a history of VTEs and hypercoagulable states. Primary outcomes analyzed included rates of 90-day VTEs, along with lower extremity deep vein thromboses and pulmonary embolisms, 90-day readmission rates, in addition to day of surgery, and 90-day costs of care. A P-value less than .05 was considered statistically significant.

Patients who have RA were found to have significantly higher incidence and odds (OR) of VTEs (1.9 vs 1.3%; OR: 1.51, P < .0001), deep vein thromboses (1.6 vs 1.1%; OR: 1.55, P < .0001), and pulmonary embolisms (0.4 vs 0.3%; OR: 1.26, P= .0001). Study group patients also had significantly higher incidence and odds of readmissions (21.6 vs 14.1%; OR: 1.67, P < .0001) compared to controls. In addition, RA patients incurred significantly higher day of surgery ($12,475.17 vs $11,428.96; P < .0001) and 90-day costs of care ($15,937.34 vs $13,678.85; P < .0001).

After adjusting for age, sex, and comorbidities, the study found patients who have RA undergoing primary TKA had significantly higher rates of VTEs, readmissions, and costs.

Read the original:
Rheumatoid Arthritis Increases Venous Thromboemboli, Readmissions, and Costs of Care After Primary Total Knee Arthroplasty: A Matched-Control Analysis...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that positive results from a Phase 3 investigational study of tofacitinib in children and adolescents aged two to less than 18 with juvenile idiopathic arthritis (JIA) will be presented for the first time during a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting (November 8-13, Atlanta, GA). The study of tofacitinib in JIA is investigative and JIA is not an FDA-approved indication for XELJANZ. Pfizer has plans to file for the indication in 2020.

The JIA study is a Phase 3, randomized, double-blind, placebo-controlled withdrawal study that included 225 patients with polyarticular course JIA (n=184), psoriatic arthritis (n=20) or enthesitis related arthritis (n=21). The study evaluated the efficacy and safety of tofacitinib taken as either a 5 mg tablet or as a 1 mg/mL oral solution twice daily based on the subjects body weight.

The trial met its primary endpoint showing that in patients with polyarticular JIA, the occurrence of disease flare in patients treated with tofacitinib was significantly lower than patients treated with placebo at week 44. In this study, disease flare was defined as a 30 percent or more worsening in at least three of the six variables of the JIA core set (outcome measures used in JIA clinical trials).

The most common adverse events in this study of any treatment group were upper respiratory tract infection, headache, nasopharyngitis, nausea, pyrexia, disease progression, vomiting and JIA. There were no cases of death, major adverse cardiovascular events (MACE), malignancies, thrombosis, opportunistic infection or tuberculosis. There were two patients with herpes zoster and four patients with serious infections in the tofacitinib treatment arm throughout the course of the study.

Pediatric patients living with juvenile idiopathic arthritis need additional options, including oral therapies, to treat this chronic inflammatory disease, said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. We are encouraged by the results from our pivotal Phase 3 investigational study of tofacitinib in patients with polyarticular juvenile idiopathic arthritis and look forward to filing for this indication with the FDA in 2020.

About the JIA Study

The A3921104 Phase 3 study had two phases. During the run-in phase, all subjects enrolled in the study received open-label tofacitinib for 18 weeks. At the end of the 18-week run in phase, only subjects who achieved at least a JIA ACR30 response were randomized into the 26-week, double-blind, placebo-controlled, withdrawal phase to receive either tofacitinib or placebo through the end of the study duration at week 44. For more information about study A3921104, please visit https://www.clinicaltrials.gov.

About XELJANZ (tofacitinib)

XELJANZ (tofacitinib) is approved in the U.S. for adult patients in three indications: moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, active psoriatic arthritis (PsA) after disease modifying antirheumatic drug (DMARD) failure and moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure. XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 208,000 adult patients (the majority of whom were RA patients) worldwide in the last seven years. 1,2,3

As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.

FDA APPROVED INDICATIONS

Rheumatoid Arthritis

Psoriatic Arthritis

It is important to note that a dosage of Xeljanz 10 mg twice daily is not recommended for the treatment of rheumatoid arthritis or psoriatic arthritis.

Ulcerative Colitis

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with XELJANZ/XELJANZ XR are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.

If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled.

Reported infections include:

The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Avoid use of XELJANZ/XELJANZ XR in patients with an active, serious infection, including localized infections, or with chronic or recurrent infection.

In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily.

The risks and benefits of treatment with XELJANZ/XELJANZ XR should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and Hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ/XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.

MORTALITY

Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study.

XELJANZ 10mg twice daily or XELJANZ XR 22mg once daily is not recommended for the treatment of RA or PsA. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.

Consider the risks and benefits of XELJANZ/XELJANZ XR treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing XELJANZ/XELJANZ XR in patients who develop a malignancy.

Malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily dosing in the UC long-term extension study.

Other malignancies were observed in clinical studies and the post-marketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, has been observed at an increased incidence in RA patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study. Many of these events were serious and some resulted in death. Avoid XELJANZ/XELJANZ XR in patients at risk. Discontinue XELJANZ/XELJANZ XR and promptly evaluate patients with symptoms of thrombosis. For patients with UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. In a long-term extension study in UC, four cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice a day, including one death in a patient with advanced cancer.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in XELJANZ clinical trials, although the role of JAK inhibition is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There was no discernable difference in frequency of gastrointestinal perforation between the placebo and the XELJANZ arms in clinical trials of patients with UC, and many of them were receiving background corticosteroids. XELJANZ/XELJANZ XR should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs).

HYPERSENSITIVITY

Angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving XELJANZ/XELJANZ XR some events were serious. If a serious hypersensitivity reaction occurs, promptly discontinue tofacitinib while evaluating the potential cause or causes of the reaction.

LABORATORY ABNORMALITIES

Lymphocyte Abnormalities: Treatment with XELJANZ was associated with initial lymphocytosis at one month of exposure followed by a gradual decrease in mean lymphocyte counts. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a count less than 500 cells/mm3. In patients who develop a confirmed absolute lymphocyte count less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Monitor lymphocyte counts at baseline and every 3 months thereafter.

Neutropenia: Treatment with XELJANZ was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo. Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with an ANC less than 1000 cells/mm3. For patients who develop a persistent ANC of 500-1000 cells/mm3, interrupt XELJANZ/XELJANZ XR dosing until ANC is greater than or equal to 1000 cells/mm3. In patients who develop an ANC less than 500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not recommended. Monitor neutrophil counts at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

Anemia: Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a hemoglobin level less than 9 g/dL. Treatment with XELJANZ/XELJANZ XR should be interrupted in patients who develop hemoglobin levels less than 8 g/dL or whose hemoglobin level drops greater than 2 g/dL on treatment. Monitor hemoglobin at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

Liver Enzyme Elevations: Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation compared to placebo. Most of these abnormalities occurred in studies with background DMARD (primarily methotrexate) therapy. If drug-induced liver injury is suspected, the administration of XELJANZ/XELJANZ XR should be interrupted until this diagnosis has been excluded. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury.

Lipid Elevations: Treatment with XELJANZ was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Maximum effects were generally observed within 6 weeks. There were no clinically relevant changes in LDL/HDL cholesterol ratios. Manage patients with hyperlipidemia according to clinical guidelines. Assessment of lipid parameters should be performed approximately 4-8 weeks following initiation of XELJANZ/XELJANZ XR therapy.

VACCINATIONS

Avoid use of live vaccines concurrently with XELJANZ/XELJANZ XR. The interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.

PATIENTS WITH GASTROINTESTINAL NARROWING

Caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non-deformable extended release formulation.

HEPATIC and RENAL IMPAIRMENT

Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.

For patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 5 mg twice daily, reduce to XELJANZ 5 mg once daily.

For UC patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 10 mg twice daily, reduce to XELJANZ 5 mg twice daily.

ADVERSE REACTIONS

The most common serious adverse reactions were serious infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical trials in patients with rheumatoid arthritis (RA) with XELJANZ 5 mg twice daily and placebo, respectively, (occurring in greater than or equal to 2% of patients treated with XELJANZ with or without DMARDs) were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension. The safety profile observed in patients with active psoriatic arthritis treated with XELJANZ was consistent with the safety profile observed in RA patients.

Adverse reactions reported in 5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and 1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials for UC were: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.

USE IN PREGNANCY

Available data with XELJANZ/XELJANZ XR use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal studies, tofacitinib at 6.3 times the maximum recommended dose of 10 mg twice daily demonstrated adverse embryo-fetal findings. The relevance of these findings to women of childbearing potential is uncertain. Consider pregnancy planning and prevention for females of reproductive potential.

Please see full Prescribing Information, including BOXED WARNING for XELJANZ/XELJANZ XR available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

Pfizer Inc.: Breakthroughs that change patients lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of November 12, 2019. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about XELJANZ (tofacitinib) and a potential new indication for the treatment of juvenile idiopathic arthritis, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; uncertainties regarding the commercial success of XELJANZ and XELJANZ XR; uncertainties regarding the commercial impact of the update to the U.S. prescribing information for XELJANZ and XELJANZ XR; uncertainties regarding the commercial impact of any potential actions by other regulatory authorities, including as a result of the ongoing review by the European Medicines Agencys scientific committee, based on analysis of clinical trial A3921133 or other data, which will depend, in part, on labeling determinations; whether and when any applications for the potential new indication for XELJANZ may be filed in any jurisdictions; whether and when any applications that may be filed for the potential new indication or that may be pending or filed for any other potential indications for XELJANZ or XELJANZ XR in any jurisdictions may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the products benefits outweigh its known risks and determination of the products efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, safety, manufacturing processes and/or other matters that could affect the availability or commercial potential of XELJANZ and XELJANZ XR; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

_______________________1 Pfizer Data on File. XELJANZ Worldwide Registration Status.2 ClinicalTrials.gov. Tofacitinib RA Studies. https://clinicaltrials.gov/ct2/results?term=tofacitinib%2C+rheumatoid+arthritis%2C+ORAL&type=&rslt=&recr=&age_v=&gndr=&cond=Rheumatoid+Arthritis&intr=&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&rcv_s=&rcv_e=&lup_s=&lup_e=. Accessed August 1, 2019.3 Pfizer. Data on File. Tofa Counts. April 2019

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Pfizer Announces Results of Phase 3 Study for XELJANZ (tofacitinib) in Juvenile Idiopathic Arthritis Ahead of Presentation at 2019 American College of...

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The sixth annual Arkansas Bioinformatics Consortium conference is set for Feb. 10-11 at the Wyndham Riverfront in North Little Rock. Its theme is Artificial Intelligence in Arkansas.

AR-BIC is an annual event, but its meant to be a collaborative community of research scientists and practitioners in this field of bioinformatics, said Jeremy Harper, director of communications for the Arkansas Research Alliance.

ARA, headquartered in Conway, is the lead organizer of the conference. The Food & Drug Administrations National Center for Toxicological Research in Jefferson County is a major sponsor.

Harper said conference registration is free and complementary lodging is available, thanks to a $15,000 grant from the FDA and sponsorships that cover what remains of its $40,000-$50,000 budget.

The conference will be held from 1-7:30 p.m. Feb. 10 and from 8:30 a.m.-4:30 p.m. Feb. 11.

AR-BIC was born out of a realization by the NCTRs Division of Bioinformatics & Biostatistics and others that we have a real developing, emerging competency in bioinformatics here in the state and it needed to be nurtured, Harper said. The objectives of AR-BIC, he said, are to:

The first conference attracted 90 attendees, and attendance has been growing since then, Harper said. More than 200 attended the 2019 conference.

The AR-BIC governing board oversees the conference. The board includes representatives from Arkansas State University, the University of Arkansas, the University of Arkansas at Little Rock, the University of Arkansas for Medical Sciences, the University of Arkansas at Pine Bluff, the NCTR and ARA. ARA President and CEO Jerry Adams chairs it. Entities represented on the board provide most of the conferences speakers.

Highlights of the 2020 conference include a new panel composed of ARA Academy scholars and fellows and a theme that is on point, Harper said.

This [upcoming] year is on AI, and theres just been an explosion of growth around AI, he said. The computational requirements of personalized medicine alone, not to mention things like driverless cars and all that, make it a pretty strategic theme.

Harper also said the FDA, a major sponsor, will need AI to do its job, which is to protect human health.

In addition, the topic is timely, he said, because ARA fellow Xiuzhen Huang of A-State recently founded the Arkansas AI-Campus. It is a virtual statewide interactive training program seven institutions are participating in. The program allows researchers to work with global and national experts in machine learning, artificial intelligence and deep learning. Deep learning is the practice of imitating the workings of the human brain in processing data and creating patterns for use in decision-making.

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Conference to Focus on AI in Arkansas - Arkansas Business Online

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov 18, 2019--

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that results from a number of studies across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019. These data include new results in HER2-positive breast cancer and studies of new molecules in hormone receptor-positive (HR-positive) breast cancer.

For the past three decades, we have remained dedicated to improving outcomes for people with breast cancer, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. This sustained commitment is exemplified by new data for our approved and investigational medicines across the spectrum of breast cancer being presented at SABCS this year.

Key presentations

New data will be presented from a second interim overall survival (OS) analysis of the Phase III APHINITY trial evaluating Perjeta (pertuzumab) and Herceptin (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC). This latest interim OS analysis also includes updated descriptive invasive disease-free survival and cardiac safety data.

Genentech will also present data from the primary analysis of the Phase III FeDeriCa study which evaluated a new investigational fixed-dose combination (FDC) of Perjeta and Herceptin administered as a single subcutaneous formulation in combination with intravenous chemotherapy. The FDC is administered under the skin in just minutes, significantly reducing the time spent receiving treatment and providing people with HER2-positive breast cancer a potential new treatment option for faster delivery of the Perjeta-based regimen.

Data will also be presented from studies in HR-positive breast cancer, including findings from early studies investigating Genentechs pipeline molecules GDC-9545, a selective estrogen receptor degrader, and GDC-0077, a mutant selective PI3K inhibitor.

Overview of Genentech studies to be presented at SABCS 2019

Medicine(s)

Abstract title

Abstract number

(date, time, location of presentation)

HER2-positive breast cancer

Perjeta and Herceptin

Interim OS analysis of APHINITY (BIG 4-11): a randomized multicenter, double-blind, placebo-controlled trial comparing chemotherapy plus trastuzumab plus pertuzumab versus chemotherapy plus trastuzumab plus placebo as adjuvant therapy in patients with operable HER2-positive eBC

Abstract GS1-04

(Oral)

Wednesday, December 119:30 9:45 AM CST

Hall 3

Perjeta and Herceptin

Subcutaneous trastuzumab and hyaluronidase-oysk with intravenous pertuzumab and docetaxel in HER2-positive advanced breast cancer: final analysis of the Phase IIIb, multicenter, open-label, single-arm MetaPHER study

Abstract P1-18-05

(Poster)

Wednesday, December 115:00 7:00 PM CST

Hall 1

Perjeta and Herceptin

Risk of recurrence and death in patients with early HER2-positive breast cancer who achieve a pathological complete response (pCR) after different types of HER2-targeted therapy: a retrospective exploratory analysis

Abstract P1-18-01

(Poster)

Wednesday, December 115:00 7:00 PM CST

Hall 1

Perjeta and Herceptin

Use of pertuzumab in combination with taxanes for HER2-positive metastatic breast cancer (MBC): analysis of United States electronic health records

Abstract P1-18-14

(Poster)

Wednesday, December 115:00 7:00 PM CST

Hall 1

Kadcyla (ado-trastuzumab emtansine)

Cardiac events in patients with HER2-positive MBC who have low left ventricular ejection fraction prior to initiating treatment with ado-trastuzumab emtansine: a retrospective cohort study using electronic health record data

Abstract P1-18-11

(Poster)

Wednesday, December 115:00 7:00 PM CST

Hall 1

Tecentriq (atezolizumab), Kadcyla, Perjeta and Herceptin

Atezolizumab in combination with ado-trastuzumab emtansine or with trastuzumab and pertuzumab in patients with HER2-positive breast cancer and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer: safety and biomarker outcomes from a multi-cohort Phase Ib study

Abstract PD1-05

(Poster discussion)

Wednesday, December 115:00 7:00 PM CST

Hemisfair Ballroom

Perjeta and Herceptin

Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive eBC: primary analysis of the Phase III, multicenter, randomized, open-label, two-arm FeDeriCa study

Abstract PD4-07

(Poster discussion)

Thursday, December 12

7:00 9:00 AM CST

Stars at Night Ballroom 1&2

Kadcyla and Perjeta

Association of immune gene expression with outcome in the MARIANNE Phase III clinical trial in HER2-positive MBC

Abstract PD5-11

(Poster discussion)

Thursday, December 12

7:00 9:00 AM CST

Stars at Night Ballroom 3&4

Kadcyla and Herceptin

Adjuvant ado-trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: KATHERINE subgroup analysis

Abstract P3-14-01

(Poster)

Thursday, December 12

5:00 7:00 PM CST

Hall 1

Herceptin

Palbociclib in combination with trastuzumab and endocrine therapy versus treatment of physician's choice in metastatic HER2-positive and HR-positive breast cancer with PAM50 luminal intrinsic subtype (SOLTI-1303 PATRICIA II): a multi-center, randomized, open-label, Phase II trial

Abstract OT2-02-06

(Poster)

Thursday, December 12

5:00 7:00 PM CST

Hall 1

Kadcyla and Herceptin

Cost-effectiveness of ado-trastuzumab emtansine versus trastuzumab for the adjuvant treatment of patients with residual invasive HER2-positive eBC in the United States

Abstract P6-13-01

(Poster)

Saturday, December 14

7:00 9:00 AM CST

Hall 1

Hormone receptor-positive

GDC-0077

A first-in-human Phase Ia dose escalation study of GDC-0077, a p110a-selective and mutant-degrading PI3K inhibitor, in patients with PIK3CA-mutant solid tumors

Abstract OT1-08-04

(Poster)

Wednesday, December 11

5:00 7:00 PM CST

Hall 1

GDC-0077

A Phase Ib dose escalation study evaluating the mutant selective PI3K-alpha inhibitor GDC-0077 in combination with letrozole with and without palbociclib in patients with PIK3CA-mutant HR-positive, HER2-negative breast cancer

Abstract P1-19-46

(Poster)

Wednesday, December 11

5:00 7:00 PM CST

Hall 1

GDC-9545

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Genentech to Present New and Updated Data for Seven Approved and Investigational Medicines Across Multiple Types of Breast Cancer at the 2019 San...

Why has nobody really 3D printed a heart yet? Will animals also benefit from 3D printing in the veterinary field? How to start a 3D printing lab in a public hospital? And who is Gary? These are just a few of the proposals answered at the latest and fifth edition of the 3D Med Australia Conference, which concluded last Saturday after three days of workshops, lab tours, and lectures at the AAMI Park, a huge Stadium in Melbourne. The event highlighted 3D printing applications in various health areas like presurgical planning in adult and pediatric fields, bioprinting, medical device design, prosthetic and implantable device design, education of trainees and medical students, as well as patient experience, and even 3D printing to support longevity of equipment for helicopter retrieval (from blood warmers to vial containment).It is the largest 3D technologies in medicine conference in Australasia, convened by Jason Chuen, Associate Professor at The University of Melbourne and Director of Vascular Surgery at Austin Health, in Melbourne, and Jasamine Coles-Black, doctor and vascular researcher at the Department of Vascular Surgery at Austin Health and Austin 3D Medical Printing Laboratory (Austin 3D Med Lab). Apart from featuring frontier health innovation in 3D printing, it was attended by most major labs and scientists in this space.

The highly awaited experience showcased The University of Melbournes experience in this space, as a recognized hotspot of medical device innovation. The multidisciplinary nature of frontier technologies in health meant the work presented is a result of the collaboration between doctors, engineers, veterinarians, cell biologists, industrial designers, lawyers, and policymakers.

3D technologies, including 3D printing and augmented reality, are set to radically transform the way we teach, train, plan, rehearse, and perform surgery; and Australia is lining up to be one of the leaders in the field, said Chuen. We are proud to support this by bringing together all of these great minds: from what I can see, Australia, and Melbourne, in particular, will be a major hub of medical technology development, and 3D related technologies will be a key part of this.

Atandrila Das, General Surgeon at Northern Health, Melbourne, presented a world-first case combining 3D visualization with robotic cancer surgery, which was a result of a collaboration between Austin Health and the Peter MacCallum Cancer Centers Department of Surgery doctoral students and surgeons. In addition, Claudia di Bella, Orthopaedic Surgeon, and researcher at Biofab3D in St Vincents Hospitalat The University of Melbourne exhibited her robotics and tissue engineering work.

Additionally, ethics and regulation were a big part of the event, with attendees getting updates from Australian governing bodies like the Therapeutic Goods Administration (TGA), the Department of Health and Human Services (DHHS), and Medical Device Innovation. The TGAs John Skerritt provided leading researchers with an update on the current changes to custom medical device and implant regulations coming in late November. Some of the proposals for change include a medical device production system framework to allow healthcare providers to produce lower risk personalized devices without manufacturing certification and regulation of medical devices with a human origin component as medical devices with a biological component rather than biologicals.

What is wrong with this image? OConnell explains why nobody has really 3D printed a heart yet (Image Credit: Cathal OConnell)

During the talk Dont Print Your Heart Out, facility manager at BioFab3D, Cathal OConnell, dissected the hype from reality and explained why nobody has really 3D printed a heart yet, suggesting it is dangerous to provoke so much buildup in platform technologies and how clinicians, scientists, and reporters need to be careful when delivering their message on medical technologies.

In the original printed heart scientific paper, Israeli scientists describe [] the main focus was to print a square patch of heart cells and blood vessels using a personalized bioink. As a final flourish, the team also printed the cells into a thumbnail-sized, heart shape. The text of the original paper clearly states the printed heart-shaped structure is not a real heart and lacks most of the features required to make a heart work. This is impressive work the cardiac patches may indeed turn out to be an important development in the field. Im more worried about media reports giving the impression that our field of research is far more advanced than it is, said OConnell.

Elizabeth Sigston at the Women in 3D Med Event (Image Credit: Austin 3D Med Lab)

While Blake Cochran, from the University of New South Wales (UNSW), Sydney, introduced Gary, a 3D printed radiologically realistic skull, and Stewart Ryan, from The University of Melbourne Universitys vet school, explored the importance of 3D printing for the training of veterinary surgeons for all creatures great and small, and Ryan should know, he has even performed surgery for a 14-year old tiger at the Melbourne Zoo to remove a cancerous tumor.

As part of the event, the inaugural Women in 3D Technologies networking drinks were held in partnership with the Commonwealth Scientific and Industrial Research Organisation (CSIRO), with Elizabeth Sigston (a leading head and neck cancer surgeon) giving the keynote speech. The conference proved that there is a strong representation of women in STEMM careers across Medicine, Dentistry and Health Sciences (MDHS) in Melbourne.

3D technologies are the natural next steppingstone in the era of personalised medicine, said Coles-Black. Australian doctors, engineers and other researchers need to come together in order to make the most of this new frontier in medicine. Our conference provides a collegiate environment for much-needed multidisciplinary collaboration.

Jason Chuen, Elizabeth Sigston, Frank McGuire, and Jasamine Coles-Black at the 3D Med Conference (Image Credit: Austin 3D Med Lab)

Coles-Black also explained that this conference seeks to bring together experts to solve the often-quoted barriers to the adoption of 3D printing technologies in healthcare settings, such as the lack of technical and regulatory knowledge, perceived costs, and lack of expertise in implementation.

A tour of RMITs Additive Manufacturing Precinct (Image Credit: Austin 3D Med Lab)

In addition, the conference featured a tour of the new MDHS SBS Digital Learning Hub. Other University of Melbourne labs featured through hands-on tours included the Melbourne School of Designs NExT Lab and BioFab3d, Austin 3D Med Lab, and the Australian Research Council Training Centre for Medical Implant Technologies (ARC-CMIT)which launched on November 8. In addition, there was a significant focus on industry, startup and commercialization, and medical device development with representatives from the Medical Device Partnering Program, Stratasys, HP, Evok3D, Kyocera, Leapfrog, Gore, Global3D and Materialise.

Clinicians and engineers need to work together to develop this technology and find ways to implement it effectively and safely. Collaboration is key in this industry, claimed Chuen.

During the occasion, there was a lot of hype about the clinical uses of augmented and virtual reality in presurgical planning, medical student education, forensics, trauma simulation, and to improve hospital systems.

At the Anatomical 3D Segmentation Workshop, in collaboration with Evok3D, an HP 3D Partner in Australia, guests learned more about the end-to-end workflows for the production of 3D printed color anatomical models, which can be used to improve pre-surgical planning, patient consultation, and support medical education. Medical 3D technology for patient care is getting more and more accessible, every day, providing patients personalized treatment based on their scans as point-of-care 3D printing enables manufacturing directly on location.

Promotional booths were a big part of the event, with visitors looking into how Materialise solutions can provide personalized treatment to patients and guidance on setting up a 3D point-of-care facility at hospitals. And Stratasys even chose the 3D Med Conference to launch its J750 Digital Anatomy Printer in the Australasia region.

The last day of the event kicked off with Mia Woodruff, Professor of Biomedical Engineering at Queensland University of Technology (QUT), and Gordon Wallace, a distinguished professor at theUniversity of Wollongong (UOW), talking about the future of bioprinting. Woodruff shared challenges and motivations to translate biofabrication in the hospital of the future, and along with Wallace announced the Biofabrication 2020 event: Biofab by the Beach, set for September 27 through 30, in 2020, proving its all about teamwork, something Wallace was keen on emphasizing during his panel, claiming cross-disciplinary collaboration is key and Australia leads the way as Australians are collaborative by nature. Finally, rounding up the event was Peter Lee, Director of the ARC CMIT, focusing on building the multidisciplinary networks needed to train the new generation of implant engineers. Thats what it was all about at the 3D Med Conference, looking into the future for biotechnology and medical applications that will pave the way for future research and adoption of 3D printing technology.

The entrance to the 3D Med Conference (Image Credit: Austin 3D Med Lab)

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Australias 3D Printing Medical Conference: Focusing on Technology and Teamwork to Advance the Field - 3DPrint.com

New Orleans, LA, November 18, 2019 --(PR.com)-- David Crais, CEO of CMG Carealytics, was invited to the 4th Cross-Industry Innovation Summit held at Johnson Space Center in Houston, Texas last week. An exclusive group of Chief Innovation Officers from NASA, the US Navy, Army, Columbia University Business School, Barnard College, Amazon, Google, Dow Jones, and other global organizations.

Held over three days last week at Johnson Space Center, the Cross Industry Innovation Summit is a deep dive into innovation theory and practice from venture capital, startups, and technology transfer to corporate innovation labs and research and development programs. Exploring the discovery and investigative process with manufacturing, development, and commercialization and adoption of emerging technologies, new ideas, and new program development, these business, social, and government leaders work hands on to share ideas and cultural outlook and framework to bring about advances to their domains and constituencies . This is the fourth year of the program and the fourth year David Crais was asked to participate.

CMG Carealytics, a product management and development firm specializing in scientific, medical, and complex systems and industries, is known as a leader in the innovation and commercialization field. Working with incubators, accelerators, R&D teams, tech parks, venture capital firms, and expert networks, CMG Carealytics founded and led by David Crais continues to spearhead new innovation methods and practices in quality engineering, agile, scrum, lean, buisness analysis, product management, and other sociotechnical methods and in technologies from biotech, regenerative medicine, medical device, digital medicine, personalized medicine, printed electronics, imaging, thermography, and other technologies.

Crais has been engaged in innovation theory since his university education in scientific history and social change up to his development of medical technologies and taking them to market as publicly traded companies, private placements, new product launches, non-profits, and with economic development initiatives.

His participation in the Cross-Industry Summit with NASA is in addition to his work in serving on the Master Plan Task Force with Stennis Space Center in Mississippi, as a board member on the LSU Stephenson Entrepreneurship Institute, an advisor to Nevada State College Entrepreneurship Program, UC Irvine Medical Technology Commercialization Program, and with organizations like the Urban Land Institute, Angel Capital Association, Association for Corporate Growth, and other roles.

Contact Information:CMG CarealtyicsDavid Crais773-398-4143Contact via Emailcraisgroup.comghartman1@hotmail.com

Read the full story here: https://www.pr.com/press-release/799655

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David Crais of CMG Carealytics Invited to NASA Cross Industry Innovation Summit - Benzinga

Augmentedintelligence(AI) iscertainto bea key player in revolutionizinghealthcare for the next generation of physiciansand patients. Butwhat about actual intelligence, the kind producedby human brains?

It, too, will be instrumental, AMA Executive Vice President and CEO James L. Madara, MD, noted in his address to delegates at the opening session of the 2019 AMA Interim Meeting in San Diego.

To make his point, Dr. Madara cited a recent anecdote from tech entrepreneur and investor Elon Musk, the founder of electric automaker Tesla. When the car company struggled to keep up with the production schedule on the Tesla Model 3, Musk came to the conclusion that the problem was an overreliance on AI.

Now, this story captures two principles, Dr. Madara said. The first is that to produce something of value, one needs to perform a complicated series of discrete actions in a highly coordinated way. The second, the best outcomes may require powerful technologies optimally mixed with distinctively human capabilities.

These principles, Dr. Madara said, are reflected in the AMAs work on evaluating and acting on chronic disease. Among the interventions the CEO cited:

Policies and reports adopted in the AMA House of Delegates over the past half decade that detail significant health burdens of diabetes and hypertension.

When complete, our collective work will have ushered in more accurate and organized measures of blood pressure, better insights into how to better control blood pressure, no paperwork, and added revenue to physicians for evaluating and acting on hypertension, this the No. 1 killer in our society, Dr. Madara said.

This blood pressure story is but one example of how were harnessing the power of the AMAexpertise across many units cross-leveraging many strengthsand doing so in a systematic and coordinated fashion.

In providing additional examples of what can be accomplished with the collective power of the AMAs membership, Dr. Madara again called out the AMA Ed Hub.

Launched in May, the platform hosts a broad spectrum continuing medical education (CME) content. Some of that material is sourced from the American College of Radiology, with other medical specialties, expressing interest in a similar arrangement.

Ed Hub also began electronically syncing CME offerings with specialty boards, such as the American Board of Internal Medicine, and has the capability to connect with state licensing processes. That atuomatic tracking is now being piloted in North Carolina, Tennessee and Maine, and other states will follow.

Taking the concept of innovation a step further, Ed Hub is working with the AMAs tech incubator, Health2047 Inc., to potentially develop AI features that could personalize a physicians CME options.

Imagine a future where your CME choices are crafted as a bespoke menu, customized to what you actually see in your practice, and where the hassles of filling out forms for credentialing and licensing disappear. Thats the pathway were building, Dr. Madara said.

Technology advancements, Dr. Madara said, are only a tool to provide better carenot a way to replace physicians, nurses and other dedicated health professionals.

Dr. Madara illustrated that point through the changes in the process of counting blood cell types. As a medical student, he counted them using a clicker. Over time, that process changed from a clicker to a coulter counter to a flow cytometers to a cell separator.

Each time, the old task was replaced by a more interesting new taskallowing advances in diagnosis and therapy, he said.When it comes to powerful new tools and machines, its important to remember these replace tasks, not jobs. Its our role to imagine new frontiersnew tasksthat further advance our fields with yesterdays brute labor now taken up by the machines.

In the end, more time with patients for physicians because of these advancements will change the job, in a way that makes it more fulfilling.

Count me among those excited about the future of medicine, and the powerful new tools that will define the new era of personalized patient care, and also personalized physician education driven by the AMA Ed Hub, he said. Im confident in the physicians ability to always reach the next future statein part because physicians will always have the AMA as their powerful ally in patient care, and because we will forever strive to promote the art and science of medicine and the betterment of public health.

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The right tech can help give doctors back time with patients: AMA CEO - American Medical Association

According to the report, the global artificial intelligence (AI) in medicine market generated $719 million in 2017 and is expected to garner $18.12 billion by 2026, growing at a CAGR of +49.6% during the forecast period.

The growth of global artificial intelligence (AI) in the medical market is driven by a surge in AI functioning due to increased processing capacity, the need to compensate for the lack of skilled professionals in health care, and increased awareness of the importance of personalized medicine. . But the limitations of AI in decision making and the slow acceptance of AI by healthcare professionals hinder market growth. Nevertheless, as the adoption of AI technology increases in developing countries, it will soon be a lucrative opportunity for players in emerging markets.

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Companies Profiled in this Report Includes:Welltok, Inc., Intel Corporation, Nvidia Corporation, Google Inc., IBM Corporation, Microsoft Corporation, General Vision, Inc., Enlitic, Inc., BioXcel Corporation, and Berg Health.

Increased investment in pharmaceutical and biotechnology companies for Artificial Intelligence in Medicine and the growing number of patients requiring organ transplantation are key factors supporting the growth of the Artificial Intelligence in Medicine market worldwide. In addition, animal research and testing bans are expected to drive Artificial Intelligence in Medicine across a variety of applications. However, high initial investment can inhibit market growth. In addition, the development of Artificial Intelligence in Medicine for making customized cosmetics will provide growth opportunities for the market in the near future.

The key questions answered in the report:

The global Artificial Intelligence in Medicine market is classified as technology, application and end user. By technology, the market is classified as extracellular matrix, bioreactor, gel, scaffold free platform and microchip. Depending on the application, the market is subdivided into research, drug discovery, tissue engineering, clinical applications and stem cell biology. End users are also divided into laboratories and laboratories, biotechnology and biopharmaceutical industries, and hospitals and diagnostic centers.

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A viable analysis of the Artificial Intelligence in Medicine market has also been provided in this statistical report in which the outlines of the key market players have been studied thoroughly to regulate the markets hierarchy. As per the research report, the market is greatly uneven and competitive due to the number of participants. This research study is intended to give a clear picture of the Artificial Intelligence in Medicine market to the readers in order to benefit them in gaining a better understanding of this market.

Globally, Europe, Asia-Pacific, North America, Middle East & Africa and Latin America are the geographical regions of the market for agricultural impetus. This Artificial Intelligence in Medicine market report also elaborates on the drivers, restraints and opportunities of the market in the present and forthcoming years.

Objectives of this research report:

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Tremendous Opportunities in Artificial Intelligence in Medicine Market 2019 Development Trend and Forecast with Top Players | Welltok, Inc., Intel...

Cardiac resynchronization therapy (CRT) improved left ventricular ejection fraction(LVEF) after six months in cancer survivors with chemotherapy-induced cardiomyopathy, according to a study published in JAMA.

The uncontrolled, prospective, cohort Multicenter Automatic Defibrillator Implantation TrialChemotherapy-Induced Cardiomyopathy study was conducted between November 21, 2014, and June 21, 2018, at 12 U.S. tertiary centers with cardio-oncology programs.

A total of 30 patients (mean age, 64 years) were implanted with CRT due to reduced LVEF (defined as 35%), New York Heart Association class II-IV heart failure symptoms, and wide QRS complex, with established chemotherapy-induced cardiomyopathy. Among this cohort, 73% had a history of breast cancer and 20% had a history of lymphoma or leukemia. Twenty-six patients were evaluable for primary endpoint data (change in LVEF from baseline to six months after CRT initiation).

Patients had non-ischemic cardiomyopathy with left bundle branch block, a median LVEF of 29%, and a mean QRS duration of 152 ms.

Patients with CRT experienced a statistically significant improvement in mean LVEF at six months, up from 28% to 39% (95% CI, 8.0-13.3;P<0.001). Patients with CRT also had a reduction in left ventricular (LV) end-systolic volume from 122.7 to 89.0 mL (95% CI, 28.2-45.8), as well as a reduction in LV end-diastolic volume from 171.0 to 143.2 mL (95% CI, 22.1-41.6; P<0.001 for both).

Treatment-related adverse events included a procedure-related pneumothorax (n=1), a device pocket infection (n=1), and heart failure requiring hospitalization during follow-up (n=1).

The study is limited by its small patient cohort, short duration of follow-up, and lack of control group.

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Cardiac Resynchronization Therapy Helps Cancer Survivors With Heart Failure - DocWire News

The Ambulatory Healthcare IT market report contains thorough description, competitive scenario, wide product portfolio of key vendors and business strategy adopted by competitors along with their SWOT analysis and porters five force analysis. This report gives an actionable market insight to the clients with which they can create sustainable and profitable business strategies. This market research report is an absolute outline of the global industry which is penned down so that an unskilled individual as well as professional can easily extrapolate the entire Ambulatory Healthcare IT market within a few seconds. According to this market report, new highs will take place in the Ambulatory Healthcare IT market in 2019 2026.

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Ambulatory care is also referred as outpatient care. It is a medical care given on outpatient criteria such as consultation, rehabilitation, observation, intervention, diagnosis, and treatment services. Ambulatory care involves emergency care, primary care, ambulatory services, and others. In this intervention and surgery, overnight hospital stay is not required.

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Few of the major market competitors currently working in the global ambulatory healthcare IT market are AmSurg Corp, Surgical Care Affiliates, Surgery Partners, Healthway Medical Group, SurgCenter, Trillium Health Partners, Medical Facilities Corporation, Nueterra Capital, Aspen Healthcare, Suomen Terveystalo Oy, IntegraMed America, Inc., SHERIDAN HEALTHCARE, NueHealth, Athenahealth, GENERAL ELECTRIC, Optum, Inc., Apria Healthcare Group, Inc., DaVita Inc., LVL Medical, Fresenius Kabi AG, Sonic Healthcare among others.

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The predictions featured in this report have been derived using proven research methods and standards. With this data, the research report serves as a source of information and analysis for every segment of the market, including but not restricted to: local markets, product, and application.

Global Ambulatory Healthcare IT Market By Type (Ambulatory Services, Primary Care Offices, Outpatient Departments, Emergency Departments, Surgical Specialty, Medical Specialty, Others), Modality (Hospital-affiliated, Freestanding), Surgery Type (Opthalmology, Orthopedics, Gastroenterology, Pain Management, Others), Application (Laceration Treatment, Bone Fracture Treatment, Emergency Care Service, Trauma Treatment)

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North America

South America

Asia and Pacific region

Middle east and Africa

Europe

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Ambulatory Healthcare IT Market Syndicated Research, Industrial Analysis With AmSurg Corp, Surgical Care Affiliates, Surgery Partners, Healthway...

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cellular therapies for unmet medical needs, today provided an update on OPC1, the Companys oligodendrocyte progenitor cell (OPC) therapy currently being tested in a Phase I/IIa clinical trial, the SCiStar Study, for the treatment of acute spinal cord injury (SCI). Lineage reported positive results from the ongoing SCiStar study of OPC1, where the overall safety profile of OPC1 has remained excellent with robust motor recovery in upper extremities maintained through Year 2 patient follow-ups available to date. Additionally, OPC1 manufacturing has been completely transferred to the Companys cGMP manufacturing facility in Israel and manufacturing process improvements are planned to continue throughout 2020. Moreover, Lineage intends to meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program around the middle of 2020.

We remain extremely excited about the potential for OPC1 to provide enhanced motor recovery to patients with spinal cord injuries. We are not aware of any other investigative therapy for SCI which has reported as encouraging clinical outcomes as OPC1, particularly with continued improvement beyond 1 year, stated Brian M. Culley, CEO of Lineage Cell Therapeutics. Overall gains in motor function for the population assessed to date have continued, with Year 2 assessments measuring the same or higher than at Year 1. For example, 5 out of 6 Cohort 2 patients have recovered two or more motor levels on at least one side as of their Year 2 visit whereas 4 of 6 patients in this group had recovered two motor levels as of their Year 1 visit. To put these improvements into perspective, a one motor level gain means the ability to move ones arm, which contributes to the ability to feed and clothe oneself or lift and transfer oneself from a wheelchair. These are tremendously meaningful improvements to quality of life and independence. Just as importantly, the overall safety of OPC1 has remained excellent and has been maintained 2 years following administration, as measured by MRIs in patients who have had their Year 2 follow-up visits to date. We look forward to providing further updates on clinical data from SCiStar as patients continue to come in for their scheduled follow up visits.

SCiStar Study Clinical Update

- Overall safety profile of OPC1 to date is excellent for Year 2 follow-ups available to date (21 patients)

- Motor level improvements

- Upper Extremity Motor Score (UEMS)

OPC1 Clinical Program Update

About the SCiStar Clinical Study

The SCiStar Study is an open-label, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in 25 patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had essentially lost all movement below their injury site and experienced severe paralysis of the upper and lower limbs. AIS-A patients had lost all motor and sensory function below their injury site, while AIS-B patients had lost all motor function but may have retained some minimal sensory function below their injury site. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions as measured by upper extremity motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations at 30, 60, 90, 180, 270, and 365 days after injection of OPC1.

About OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) therapy currently being tested in a Phase I/IIa clinical trial known as SCiStar for the treatment of acute spinal cord injuries. OPCs are naturally-occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. The clinical development of the OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to planned manufacturing process improvements and meetings with regulatory agencies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 14, 2019 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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Lineage Cell Therapeutics Provides Update on SCiStar Clinical Study and OPC1 Spinal Cord Injury Program - Business Wire

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of REVLIMID (lenalidomide) in combination with rituximab (anti-CD20 antibody) (R) for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). If approved by the European Commission (EC), R2 will be the first combination treatment regimen for patients with FL that does not include chemotherapy.

Since its initial approval in 2007, REVLIMID has continued to demonstrate its benefits across a range of serious blood disorders in Europe and a CHMP positive opinion for this combination with rituximab is very good news for patients with follicular lymphoma. We look forward to the European Commission decision, said Tuomo Ptsi, President of Hematology/Oncology for Celgene Worldwide Markets.

In FL, a subtype of indolent NHL, the immune system is not functioning optimally.1,2 When this dysfunction occurs, the immune system either fails to detect or attack cancerous cells.1,2 Rituximab is a monoclonal antibody that targets the CD 20 antigen on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab causes B-cell lysis. Lenalidomide is an immunomodulator that increases the number and activation of T and natural killer (NK) cells, resulting in the lysis of tumor cells. The R2 combination regimen acts by complementary mechanisms to help the patients immune system to find and destroy the cancer cells.3

Given the incurable nature of FL2, a high unmet medical need exists for the development of novel treatment options with new mechanisms of action and a tolerable safety profile to help improve progression-free survival (PFS) especially in the setting of previously treated FL.

The estimated incidence of NHL in Europe was 100,055 cases in 2018; FL accounts for approximately 25% of all NHL cases and is the most common form of indolent NHL.3,4,5

Chemotherapy is a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment, said Prof. John Gribben, President of EHA and Centre for Haemato-Oncology, Barts Cancer Institute, in England The combination of REVLIMID and rituximab could represent a new, chemotherapy-free treatment option for patients with previously treated follicular lymphoma.

The CHMP positive opinion is based primarily on results from the randomized, multi-center, double-blind, Phase 3 AUGMENT study, which evaluated the efficacy and safety of the R combination versus rituximab plus placebo in patients with previously treated FL (n=295).6,7 Additionally, findings from the MAGNIFY study were included as support for the safety and the efficacy of lenalidomide plus rituximab in patients with relapsed or refractory FL, including rituximab refractory FL patients.8

The CHMP reviews applications for all member states of the European Union (EU), as well as Norway, Liechtenstein, and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the REVLIMID Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

About Follicular Lymphoma

Lymphoma is a blood cancer that develops in lymphocytes, a type of white blood cell in the immune system that helps protect the body from infection.9 There are two classes of lymphoma Hodgkins lymphoma and non-Hodgkins lymphoma (NHL) each with specific subtypes that determine how the cancer behaves, spreads and should be treated.3,10,11 Other differentiating factors of lymphomas are what type of lymphocyte is affected (T cell or B cell) and how mature the cells are when they become cancerous.11

Follicular lymphoma is the most common indolent (slow-growing) form of NHL, accounting for approximately 25% of all Non-Hodgkin lymphoma (NHL) patients.5,12 Most patients present with advanced disease usually when lymphoma-related symptoms appear (e.g., nodal disease, B symptoms, cytopenia) and receive systemic chemoimmunotherapy.5 While follicular lymphoma patients are generally responsive to initial treatment, the disease course is characterized by recurrent relapses over time with shorter remission periods.13

About AUGMENT

AUGMENT is a Phase 3, randomized, double-blind clinical trial evaluating the efficacy and safety of REVLIMID (lenalidomide) in combination with rituximab (R) versus rituximab plus placebo in patients with previously treated follicular lymphoma (FL). AUGMENT included patients diagnosed with Grade 1, 2 or 3a FL, who were previously treated with at least 1 prior systemic therapy and two previous doses of rituximab. Patients were documented relapsed, refractory or progressive disease following systemic therapy, but were not rituximab-refractory.6,7

The primary endpoint was progression-free survival, defined as the time from date of randomization to the first observation of disease progression or death due to any cause. Secondary and exploratory endpoints included overall response rate, durable complete response rate, complete response rate, duration of response, duration of complete response, overall survival, event-free survival and time to next anti-lymphoma therapy.6,7

About REVLIMID

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation. REVLIMID as combination therapy is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMID is approved in Europe for the treatment of patients with mantle cell lymphoma (MCL) and in the United States for the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS

REVLIMID REMS Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID as maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction

Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision

Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment

Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy

Early Mortality in Patients with MCL: In another MCL study, there was an increase in early deaths (within 20 weeks), 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L)

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

DRUG INTERACTIONS

Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS.

Please see full SmPC for further information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond each company's control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in the Annual Report on Form 10-K and other reports of each company filed with the Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: managements time and attention is diverted on transaction related issues; disruption from the transaction make it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.

1 Scott DW, Gascoyne RD. The tumour microenvironment in B cell lymphomas. Nat Rev Cancer. 2014;14(8):517-534.2 Kridel R, Sehn LH, Gascoyne RD. Pathogenesis of follicular lymphoma. J Clin Invest. 2012;122(10):3424-3431.3 Chiu H, Trisal P, Bjorklund C, et al. Combination lenalidomide-rituximab immunotherapy activates anti-tumour immunity and induces tumour cell death by complementary mechanisms of action in follicular lymphoma. Br J Haematol. 2019;185(2):240-253.4 European Cancer Information System. Estimates of cancer incidence and mortality in 2018, for all countries. Available at: https://ecis.jrc.ec.europa.eu/explorer.php. Accessed August 2019.5 European Society for Medical Oncology. Follicular Lymphoma: A Guide for Patients. 2014. Available at: https://www.esmo.org/content/download/52236/963497/file/EN-Follicular-Lymphoma-Guide-for-Patients.pdf . Accessed September 2019.6 Leonard JP, Trneny M, Izutsu K, et al. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019;10;37(14):1188-1199.7 ClinicalTrials.gov Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT). Available at: https://clinicaltrials.gov/ct2/show/NCT01938001 Accessed September 2019.8 ClinicalTrials.gov Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma (MAGNIFY). Available at: https://clinicaltrials.gov/ct2/show/NCT01996865 Accessed August 2019.9 American Cancer Society. Lymphoma. Available at: https://www.cancer.org/cancer/lymphoma.html. Accessed August 2019.10 American Cancer Society. What is Hodgkin Lymphoma? Available at: https://www.cancer.org/cancer/hodgkin-lymphoma/about/what-is-hodgkin-disease.html. Accessed August 2019.11 American Cancer Society. What is Non-Hodgkin Lymphoma? Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html. Accessed August 2019.12 Lymphoma Action. Follicular lymphoma. Available at: https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/follicular-lymphoma. Accessed November 2019.13 Montoto S, Lopez-Guillermo A, Ferrer A, et al. Survival after progression in patients with follicular lymphoma: analysis of prognostic factors. Ann Oncol. 2002;13(4):523-30.

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Celgene Receives CHMP Positive Opinion for REVLIMID (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously...

Huaixiao Ma

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.State Key Laboratory of Genetic Resources and Evolution, Kunming Institute of Zoology, Chinese Academy of Sciences, Kunming 650223, China.Innovation Academy for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing 100101, China.

Jinglei Zhai

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.Innovation Academy for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing 100101, China.Institute of Zoology, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Beijing 100049, China.

Haifeng Wan

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.Innovation Academy for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing 100101, China.

Xiangxiang Jiang

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.Innovation Academy for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing 100101, China.

Xiaoxiao Wang

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.Innovation Academy for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing 100101, China.Institute of Zoology, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Beijing 100049, China.

Lin Wang

State Key Laboratory of Genetic Resources and Evolution, Kunming Institute of Zoology, Chinese Academy of Sciences, Kunming 650223, China.

Yunlong Xiang

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.

Xiechao He

Primate Research Center, Yunnan Key Laboratory of Animal Reproduction, Kunming Institute of Zoology, Chinese Academy of Sciences, Kunming 650223, China.

Zhen-Ao Zhao

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.

Bo Zhao

State Key Laboratory of Genetic Resources and Evolution, Kunming Institute of Zoology, Chinese Academy of Sciences, Kunming 650223, China.

Ping Zheng

State Key Laboratory of Genetic Resources and Evolution, Kunming Institute of Zoology, Chinese Academy of Sciences, Kunming 650223, China.Primate Research Center, Yunnan Key Laboratory of Animal Reproduction, Kunming Institute of Zoology, Chinese Academy of Sciences, Kunming 650223, China.Center for Excellence in Animal Evolution and Genetics, Chinese Academy of Sciences, Kunming 650223, China.

Lei Li

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.Innovation Academy for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing 100101, China.Institute of Zoology, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Beijing 100049, China.

Hongmei Wang

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China.Innovation Academy for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing 100101, China.Institute of Zoology, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Beijing 100049, China.

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In vitro culture of cynomolgus monkey embryos beyond early gastrulation - Science Magazine

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

The deal will make Editas eligible for a $70 million payment along with other possible milestones and royalties.

Its a significant expansion of the deal, Editas CSO Charlie Albright toldEndpoints News. These cells are part of the immune system and have significant potential to treat solid tumors.

Since it began in 2015, the Juno-Editas collaboration has focused largely on alpha-beta cells, the ones outfitted with the special receptors in current CAR-T treatments. Scientists at those companies and elsewhere have most publicly tried to apply CRISPR to improve CAR-T, which now work solely through viral gene transfer.

But they have also worked on expanding the approach to other immune cell types in hopes of making the treatment more effective, more accessible or as is the case with some of the gamma delta research expand it into other cancer types, especially solid tumors.

Editas has been slowly building their gamma-delta base throughout the year, Albright said. In April, they signedan agreement with BlueRock, in part to access pluripotent stem cells they hope to make into engineered gamma-delta cells that can be delivered to a patient. (Essentially a form of off-the-shelf CART).

Several companies are now pursuing gamma-delta immunotherapies, including GammaDelta Therapeutics and its new spinoff Adaptate and Regeneron-backed Adicet Bio. Theyre betting chiefly on these cells ability to penetrate the solid tumors that have been so resistant to the first wave of CAR-T treatments.

Albright argued, though, that for these techniques to work you need gene editing. Innate abilities in the cells have to be tuned up, he said. You have to increase cells persistence and enhance their ability to survive in a tumors micro-environment. Ideally, he said, you even give it new abilities, such as the power to catalyze the bodys innate immune system.

You cant do that with viral transduction, Albright said. You need gene editing.

Excerpt from:
Editas and Celgene sub Juno are tackling hottest immunotherapy cells - Endpoints News

Growing Opportunities in Global Stem Cell Banking Industry 2019

The market report envelopes all-in information on the global Stem Cell Banking Market and the nature of the market growth over the foreseeable period. The report provides a comprehensive elaboration of the positives and negatives of the global Stem Cell Banking market with Regression Analysis, S.T.E.E.P.L.E and Porters Five Forces Analysis. With SWOT analysis, the report offers detailed insights about different players operating within the Stem Cell Banking market. In addition, the analysts of the report have served the qualitative and quantitative scrutinizing of different micro- and macro-economic factors influencing the global Stem Cell Banking market.

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China Cord Blood Corporation (China), CBR Systems, Inc. (U.S.), Esperite (Netherlands), Vcanbio (U.S.), Boyalife Group (China), LifeCell (India), Crioestaminal (U.S.), RMS Regrow (Korea), Cryo-cell (U.S.), Cordlife Group (Singapore), PBKM FamiCord (Switzerland), Cells4life (UK), Beikebiotech (China), StemCyte (U.S.), Cellsafe Biotech Group (Malaysia), PacifiCord (U.S.), Familycord (U.S.), Cryo Stemcell (India), Stemade Biotech (India)

Product type Coverage (Market Size & Forecast, Major Company of Product type, etc.): Umbilical Cord Blood Stem Cell, Embryonic Stem Cell, Adult Stem Cell

Application Coverage (Market Size & Forecast, Different Demand Market by Region, Main Consumer Profile, etc.): Diseases Therapy, Healthcare

This report studies the global market size of Stem Cell Banking especially focuses on key regions like the United States, European Union, China, and other regions (Japan, Korea, India and Southeast Asia).

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Inputs of Historical Illustration: 2014 to 2018; Growth Estimation: 2019 to 2025.

Proficient Analysis of Industry, Innovation, Development, Contemporary Trends, Threats, and SWOT.

Forecasts of Market: Main products and geographies and leading divisions including applications.

Competitive Landscape Picture: Market drivers and top players, the abilities of companies with regards to manufacturing as well as continuation and potentials.

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Major Highlights of the Stem Cell Banking Market Report:

Stem Cell Banking Market Overview, Market shares, and strategies of key players, Sales Market Forecast, Industry Analysis of Stem Cell Banking Market and its Driving Factor Analysis, Market Competition Status by Major Key players, Upstream and Downstream Market Analysis of Stem Cell Banking Market. It also Contains Cost and Gross Margin Analysis of Stem Cell Banking Market.

Stem Cell Banking Market

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Understand the drivers, restraints, opportunities and trends that impact the overall growth of the Stem Cell Banking market. Grasp the market outlook in terms of value and volume. Study the strengths, weaknesses, opportunities and threats of each stakeholder operating in the Stem Cell Banking market. Learn about the manufacturing techniques of Stem Cell Banking in brief. Figure out the positive and negative factors impacting product sales.

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Regional and country-level analysis of the Stem Cell Banking market, by end-use.

Detailed analysis and profiles of additional market players.

Read more:
Stem Cell Banking Market Overview and Scope 2019 to 2025 | Key Players: China Cord Blood Corporation (China), CBR Systems, Inc. (US), & more -...