StemCell Therapy

With severe winter weather upon us, outdoor activities can result in wounds for an unfortunate few.

Precipitation, such as snow, sleet and freezing rain, can make sidewalks and parking lots dangerous. Falls are much more prevalent during these weather conditions and can result in skin tears and painful abrasions. Sitting close to fireplaces, space heaters or other heat sources can cause burns on the extremities. Many diabetics experience neuropathy keeping these burns from even being noticed, leading to an increased risk of infection.

Megan Barton, APRN, of the Wound Care Center cautions, One of the most common, but often underestimated conditions during this winter season is frostbite.

Frostbite occurs when your skin freezes during exposure to cold weather or water, causing either visible or invisible damage to your cells and soft tissues. Frostbite usually affects your extremities (fingers, toes and ears) first, but can also affect your cheeks, chin or any other exposed skin.

Too much time outdoors in the cold, particularly for those with diabetic neuropathy, can lead to frostbite. Symptoms can include numbness, swelling, blisters, redness or blackened skin.

If you have exposed skin during extremely cold temperatures, you are at risk of developing frostbite. You also are at a higher risk if you take medicine for high blood pressure, have diabetes, suffer from poor circulation, or have been drinking alcohol or taking drugs.

Timely diagnosis and treatment from experts is essential to maximize tissue salvage and achieve the best results, stresses Barton.

Winter weather can be fun for some, tedious for others, but can be dangerous for all. Dress appropriately. Be extremely aware of your extremities, if you have neuropathy. Limit your exposure to the bitter temperatures, and if you are concerned about a wound or frostbite injury, you can call Baptist Health Wound Care at (606) 526-4565 or visit BaptistHealthCorbin.com/wound. Physician referral not required.

Originally posted here:
The News Journal Baptist Health Wound Care offers help with winter wounds - The News Journal

Neuropathy Pain Treatment Market research report is the new statistical data source added by A2Z Market Research.

Neuropathy Pain Treatment Market is growing at a High CAGR during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

Neuropathy Pain Treatment Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.

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Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

Top Key Players Profiled in this report are:

Pfizer, Depomed, Eli Lilly, Endo, Grnenthal Group, Arbor Pharmaceuticals.

The key questions answered in this report:

Various factors are responsible for the markets growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Neuropathy Pain Treatment market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Neuropathy Pain Treatment markets trajectory between forecast periods.Regions Covered in the Global Neuropathy Pain Treatment Market Report 2021: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

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Regions Covered in the Global Neuropathy Pain Treatment Market Report 2021: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The cost analysis of the Global Neuropathy Pain Treatment Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

The report provides insights on the following pointers:

Market Penetration: Comprehensive information on the product portfolios of the top players in the Neuropathy Pain Treatment market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Neuropathy Pain Treatment market.

Table of Contents

Global Neuropathy Pain Treatment Market Research Report 2021 2027

Chapter 1 Neuropathy Pain Treatment Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10 Marketing Strategy Analysis, Distributors/Traders

Chapter 11 Market Effect Factors Analysis

Chapter 12 Global Neuropathy Pain Treatment Market Forecast

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Impact of COVID-19 on Neuropathy Pain Treatment Market 2021 | Size, Growth, Demand, Opportunities & Forecast To 2027 | Pfizer, Depomed, Eli Lilly,...

The end of February and beginning of March is a busy time for the U.S. Food and Drug Administration (FDA), with a number of PDUFA dates on the calendar. Read on for more.

Athenexs Oral Paclitaxel for Metastatic Breast Cancer

Athenexhas a target action date of February 28, 2021, for its New Drug Application (NDA) for Oral Paclitaxel for metastatic breast cancer, under Priority Review. The submission was built on topline data released in August 2019 for its Phase III trial.

On December 9, 2020, the company presented updated Phase III progression-free survival (PFS) and overall survival (OS) data on the clinical benefits in efficacy and tolerability of oral paclitaxel versus intravenous paclitaxel (IVP) in patients with metastatic breast cancer. The median PFS data demonstrated a benefit for oral paclitaxel compared to IVP, 8.4 versus 7.4 months, respectively, and median OS data was 23.2 months compared to 16.3 months, respectively.

The oral paclitaxel regimen appears to overcome some of the limitations of IV therapy, particularly in terms of reducing the risk of neuropathy, said Gerardo Antonio Umanzor Funez, lead investigator and medical oncologist at Centro Oncologico Integral, working with DEMEDICA of San Pedro Sula, Honduras. The lessened burden of neuropathy, the ability to manage GI side effects with prophylactic treatments, and the convenience of home-based administration, could be transformational in the treatment of metastatic breast cancer, especially in the current environment.

Blueprint Medicines Pralsetinib for Thyroid Cancer

Blueprint Medicines had a target action date of February 28 for its NDA for pralsetinib for patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. It was accepted for review under the agencys Real-Time Oncology Review (RTOR) pilot program. Its designed to assess a more efficient review process. It was approved on December 1, 2020, and will be marketed as Gavreto (pralsetinib).

The approval expanded the labeled indications for Gavreto to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, if radioactive iodine was appropriate.

Gavreto is a once-daily oral therapy that potently and selectively targets RET alterations that drive multiple tumor types. It is jointly commercialized in the U.S. by Blueprint and Genentech, a Roche company.

CorMedix Defencath for Bloodstream Infections Associated with Catheters in Hemodialysis Patients

CorMedix has a target action date of February 28 for its NDA for Defencath for the treatment of life-threatening bloodstream infections associated with the use of central venous catheters in patients receiving chronic hemodialysis. It has been designated by the FDA as a Fast Track and Qualified Infectious Disease Product, which offers an additional five years of marketing exclusivity.

On November 18, 2020, the company announced that the FDA had decided to cancel the Antimicrobial Drug Advisory Committee meeting that had been tentatively scheduled for January 14, 2021, to discuss the NDA.

Defencath is a proprietary formulation of taurolidine 1.35%, citrate 3.5% and heparin 1000 units/mL. Taurolidine is an amino acid derivative that has broad antimicrobial activity against gram-positive and -negative bacteria, including antibiotic resistant strains, in addition to mycobacteria and clinically relevant fungi including Aspergillus. The company also is working to develop Defencath as a catheter lock solution for use in oncology and total parenteral nutrition patients.

Sanofis Libtayo for Advanced Non-Small Cell Lung Cancer

Sanofihad a target action date of February 28 under Priority Review of Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with 50% PD-L1 expression. Libtayo is a fully human monoclonal antibody that targets the PD-1 immune checkpoint receptor on T-cells. On February 22, 2021, the FDA approved Libtayo for this indication. The patients must either have metastatic or locally advanced tumors that are not candidates for surgery or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations. The PD-L1 expression level is determined by an FDA-approved test.

The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease, said Naiyer Rizvi, Price Family Professor of Medicine, Director of Thoracic Oncology and Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center. Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation.

KemPharms KP415 for ADHD

KemPharmhas a target action date of March 2 for the NDA for KP415 for treatment of attention deficit hyperactivity disorder (ADHD). The drug is made up of serdexmethylphenidate (SDX), the companys prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. It is designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments, including earlier onset of action, longer duration of therapy, and avoiding unnecessary spikes in d-MPH concentrations.

On December 2, 2020, after a Late-Cycle Communication Meeting with the FDA, company president and chief executive officer Travis Mickle stated, The late-cycle review meeting with the FDA continued a series of productive meetings with the agency, and sets the stage for the next phase of the NDA review process, including the potential for confidential discussions of the KP415 product label.

Gilead and Kites Yescarta for R/R Follicular Lymphoma and Marginal Zone Lymphoma

Gilead Sciencesand Kite Pharma, a Gilead company, have a target action date of March 5 for their Yescarta (axicabtagene ciloleucel) for the treatment of follicular lymphoma (FL) and marginal zone lymphoma (MZL). The results from the ZUMA-5 clinical trial was the basis for the supplemental Biologics License Application (sBLA).

On December 5, 2020, the companies announced results from the primary analysis of ZUMA-5, a Phase II trial of Yescarta in adults with r/r indolent non-Hodgkin lymphoma (iNHL) after at least two previous lines of therapy. In the trial 92% of iNHL patients responded, including 76% with a complete response (CR) at a median follow-up of 17.5 months. The drug had previously been granted a Breakthrough Therapy Designation (BTD) by the FDA for FL and MZL.

It is encouraging to see this level of response to CAR T-cell therapy in a heavily pretreated and multiply relapsed patient population, in whom response duration to other available therapies is expected to be short, said Caron A. Jacobson, medical director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School.

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FDA Action Alert: Athenex, Blueprint, CorMedix and More - BioSpace

The treatment landscape of Waldenstrm macroglobulinemia (WM) is becoming increasingly complex with second-generation BTK inhibitors; however, the combination of bendamustine and rituximab (Rituxan; BR) remains the frontline standard of care for this patient population, said Morie A. Gertz, MD, in a virtual presentation during the 25th Annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma, an event hosted by Physicians Education Resource, LCC.

BR remains the frontline standard of care for patients with WM based on data from a phase 3 trial (NCT00991211) showing improved progression-free survival (PFS), less toxicity, and fewer relapses with BR vs R-CHOP [rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone] in patients with WM (n = 41), said Gertz, a consultant in the Division of Hematology, Department of Internal Medicine, and a professor of medicine at Mayo Clinic.1

To build upon this regimen, rituximab was evaluated as maintenance therapy in the phase 3 StiL NHL-2008 MAINTAIN trial. The study randomized 218 patients who responded to BR induction therapy to rituximab maintenance or observation. The 2-year course of rituximab maintenance led to a numerical improvement in PFS of 101 months compared with 83 months with observation in this patient population; however, the difference in PFS was not statistically significant (HR, 0.80; 95% CI, 0.51-1.25; P = .32).2 As such, rituximab maintenance is not indicated for patients with WM who respond to BR induction, said Gertz.

Other treatment options for patients with WM include bortezomib (Velcade) in combination with dexamethasone and rituximab. This regimen induced an overall response rate (ORR) of 96% in patients (n = 23) and a median time to response (TTR) of 1.4 months.3

Similarly, carfilzomib (Kyprolis) plus rituximab and dexamethasone led to an ORR of 87.1% in patients (n = 31) and a median TTR of 2.1 months.4 Moreover, responses were not affected by MYD or CXCR4 mutational status, and the combination did not cause higher than grade 1 peripheral neuropathy, explained Gertz.

Carfilzomib is less neurotoxic than bortezomib, Gertz said. Neurotoxicity is a real issue in patients with IgM monoclonal proteins [because] they have high peripheral neuropathy rates with bortezomib.

In addition to these therapies, BTK inhibitors have led to a paradigm shift in WM, said Gertz.

In 2015, ibrutinib (Imbruvica) was granted a breakthrough therapy designation by the FDA as monotherapy for the treatment of patients with WM.5 Updated results of the pivotal study that led to the approval reported an ORR of 90.5% and a major response rate of 79.4% at a median follow-up of 59 months.6 Improvement in immunoglobulin M serum (IgM), bone marrow disease involvement, and hemoglobin were also observed.

Grade 3 or greater adverse effects (AEs) included neutropenia (15.9%), thrombocytopenia (11.1%), and pneumonia (3.2%). Notably, a 12.7% rate of atrial arrhythmia was observed with ibrutinib.

Atrial fibrillation in this elderly population raises issues of anticoagulation, rate control, and ablation. It is a serious complication in this group, said Gertz.

In 2018, the FDA expanded the label for ibrutinib to include its use in combination with rituximab to treat patients with WM based on findings from the phase 3 iNNOVATE trial.7

In December 2020, the prescribing information for ibrutinib was updated to include efficacy and safety data from the final analysis of the iNNOVATE trial, which demonstrated significantly higher rates of PFS with ibrutinib/rituximab (n = 75) compared with placebo/rituximab (n = 75) in patients with treatment-nave and relapsed/refractory disease.8

At Mayo Clinic, we still use BR as our first-line [regimen], with the exception of central nervous system lymphoplasmacytic lymphoma, or so-called Bing-Neel Syndrome. In this situation, bendamustine does not cross the blood-brain barrier, but ibrutinib does, said Gertz.

Additionally, the second-generation BTK inhibitor acalabrutinib (Calquence) was evaluated in a phase 2 trial in patients with treatment-nave (n = 14) or relapsed/refractory (n = 92) WM.9 Findings from the study demonstrated an ORR of 93% in both cohorts of patients. Moreover, a lower rate of severe atrial fibrillation was observed with acalabrutinib (1%) compared with what had been reported with ibrutinib.

Another second-generation BTK inhibitor, zanubrutinib (Brukinsa) was compared with ibrutinib in the ASPEN trial, wherein the rate of complete response plus very good partial response was 28.4% with zanubrutinib compared with 19.2% with ibrutinib (P = .09).10 Notably, the 12-month PFS and 12-month overall survival rates in the overall and relapsed/refractory populations were numerically improved with zanubrutinib vs ibrutinib.

Additionally, regarding safety, zanubrutinib was associated with lower rates of atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, pneumonia, and AEs leading to treatment discontinuation or death compared with ibrutinib.

Although the efficacy improvements in the ASPEN trial were not considered statistically significant, the lower rates of toxicity suggest that zanubrutinib could have clinical utility for patients with WM, said Gertz.

Taken collectively, these data provide a potential treatment algorithm for patients with WM. At Mayo Clinic, current practice dictates that patients with IgM monoclonal gammopathy of undetermined significance with less than 10% lymphoplasmacytic infiltration, asymptomatic/smoldering WM, and patients with no cytopenias can be safely observed without therapeutic intervention. Single-agent rituximab should be given to those with IgM-related neuropathy, WM-associated hemolytic anemia, or symptomatic cryoglobulinemia. Finally, 4 to 6 cycles of BR without rituximab maintenance should be given to those patients with bulky disease, profound cytopenias, constitutional symptoms, and/or hyperviscosity symptoms, Gertz said.

Patients who had a response to previous therapy lasting 3 or more years could be considered for retreatment with their original therapy. Conversely, patients whose response was less than 3 years should be considered for zanubrutinib, acalabrutinib, or ibrutinib monotherapy if not previously used, bortezomib plus dexamethasone and rituximab if preexisting peripheral neuropathy is less than grade 2, rituximab plus dexamethasone and cyclophosphamide, or BR alone if not previously used.

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BR Retains its Role in Frontline Waldenstrm Macroglobulinemia Despite the Utility of BTK Inhibitors - OncLive

An early access treatment protocol (EAP) found that daratumumab monotherapy was safe in a population of patients with heavily treated relapsed or refractory multiple myeloma (RRMM).

Collectively, this EAP provides additional evidence of the favorable safety profile of daratumumab in patients with heavily pre-treated RRMM and the associated maintenance of patient-reported health-related quality of life (HRQoL), the researchers concluded.

Patients who were previously treated with at least three lines of therapy including a including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) or who were double refractory to a PI and IMiD were given intravenous daratumumab 16 mg/kg.

Final analysis included 293 patients who received at least one dose of daratumumab. A third of patients were from the UK, a quarter each from Spain and Italy, and 17.1% from Russia. The median age was 64 years (range, 32-85 years); 13.7% of patients were aged 75 years or older. Most patients were male (56.7%), White (93.5%), and had a baseline Eastern Cooperative Oncology Group performance status of 0 or 1 (88.7%).

Patient histories included vascular disorders (38.9%); surgical and medical procedures (31.1%); musculoskeletal and connective tissue disorders (22.9%); metabolism and nutrition disorders (20.8%); and benign, malignant, and unspecified (including cysts and polyps) neoplasms (15.0%). Comorbidities affecting more than 5% of patients included hypertension (31.4%), peripheral neuropathy (6.8%), anemia (6.8%), hypercholesterolemia (5.8%), deep vein thrombosis (5.5%), back pain (5.5%), and pulmonary embolism (5.1%).

The median duration of daratumumab exposure was 4.2 months (range, 0.03-24.1 months), and median number of infusions was 13 (range, 1-37). The overall response rate was 33.1%. Progression-free survival was 4.63 months. Overall, 60.1% of patients experienced grade 3 or 4 treatment-emergent adverse events (AEs), the most common being thrombocytopenia (18.8%), anemia (11.9%), and neutropenia (11.6%); serious AEs most commonly reported were pneumonia (4.4%) and pyrexia (4.1%).

Overall, the study yielded no new safety signals, and patients maintained their HRQoL, the study authors reported.

The study was published in Oncology and Therapy.

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Daratumumab Monotherapy Safe in Heavily Treated Relapsed or Refractory Multiple Myeloma - DocWire News