StemCell Therapy

CHICAGO, Sept. 07, 2022 (GLOBE NEWSWIRE) -- A Qualitative Research Study accomplished by Data Bridge Market research's database of 350 pages, titled as "Global Whole Exome Sequencing Market" with 100+ market data Tables, Pie Charts, Graphs & Figures spread through Pages and easy to understand detailed analysis. This Whole Exome Sequencing report contains a comprehensive data of market definition, classifications, applications, engagements, market drivers and market restraints of this industry all of which is derived from Porte's Five Forces analysis. Market definition covered in this Whole Exome Sequencing report gives the scope of particular product with respect to the driving factors and restraints in the market. The sources of data and information mentioned in the Whole Exome Sequencing report are very reliable and include websites, annual reports of the companies, journals, and mergers which are checked and validated by the market experts.

Global whole exome sequencing market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with a CAGR of 19.0% in the forecast period of 2022 to 2029. The increase in healthcare expenditure and funding are the major drivers which propelled the demand of the market in the forecast period.

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MarketSynopsis:-

Whole exome is a genomic technique for sequencing the entire protein-coding region of genes in a genome. Whole exome sequencing is available to patients who are searching for a unifying diagnosis for multiple medical conditions. A laboratory process that is used to determine the nucleotide sequence primarily of the exonic (or protein-coding) regions of an individuals genome and related sequences, representing approximately 1% of the complete DNA sequence, also called WES. Whole-exome sequencing is a widely used whole exome sequencing method that involves sequencing the protein-coding regions of the genome. The human exome represents less than 2% of the genome, but contains ~85% of known disease-related variants, making this method a cost-effective alternative to whole-genome sequencing.

Exome sequencing using exome enrichment can efficiently detect coding variants across a wide range of applications, including population genetics, genetic disease and cancer studies. The growth of the global whole exome sequencing market is attributed to the reduction in time and cost for sequencing. With the development of new technologies and cancer cure treatment, the whole exome sequencing market in clinical oncology has huge potential in the coming years.

The major companies which are dealing in the whole exome sequencing market are

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Recent Development

Opportunity

The demand for whole exome sequencing is increasing in the market owing to the increased incidence of geneticdisease along with increased geriatric population across the region. Thus, the top market players have implemented the strategy of collaboration with other market players aimed at improving business operations and profitability.

Global Whole Exome Sequencing Market Segmentation

Global Whole Exome Sequencing Market is segmented on the basis of component, product and service, application, end user and distribution channel. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Component

Product and Services

Application

End User

Distribution Channel

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Regional Analysis/insights

The whole exome sequencing market is analyzed and market size information is provided by component, product and service, application, end user and distribution channel.

The countries covered in the whole exome sequencing market report are U.S., Canada, Mexico, Germany, France, Italy, U.K., Spain, Netherlands, Russia, Switzerland, Turkey, Belgium, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific, Brazil, Argentina, Rest of South America, Saudi Arabia, South Africa, UAE, Israel, Egypt and Rest of Middle East & Africa.

North America is dominating due to the presence of key market players along the largest consumer market with high GDP. U.S. is expected to grow due to rise in technological advancement.

Key Industry Drivers:-

Drivers

As genomics-focused pharmacology continues to play a greater role in the treatment of various chronic diseases especially cancer,next-generation sequencing(NGS) is evolving as a powerful tool for providing a deeper and more precise insight at molecular underpinnings of individual tumours and specific receptors.

NGS offers advantages in accuracy, sensitivity and speed compared to traditional methods that have the potential to make a significant impact on the field of oncology. Because NGS can assess multiple genes in a single assay, the need to order multiple tests to identify the causative mutation is eliminated.

As genomics-focused pharmacology continues to play a greater role in the treatment of various chronic diseases especially cancer, next-generation sequencing (NGS) is evolving as a powerful tool for providing a deeper and more precise insight at molecular underpinnings of individual tumours and specific receptors.

NGS offers advantages in accuracy, sensitivity and speed compared to traditional methods that have the potential to make a significant impact on the field of oncology. Because NGS can assess multiple genes in a single assay, the need to order multiple tests to identify the causative mutation is eliminated.

Points Covered in Table of Content of Global Whole Exome Sequencing Market:

Chapter 1: Report Overview

Chapter 2: Global Market Growth Trends

Chapter 3: Value Chain of Whole Exome Sequencing Market

Chapter 4: Players Profiles

Chapter 5: Global Whole Exome Sequencing Market Analysis by Regions

Chapter 6: North America Whole Exome Sequencing Market Analysis by Countries

Chapter 7: Europe Whole Exome Sequencing Market Analysis by Countries

Chapter 8: Asia-Pacific Whole Exome Sequencing Market Analysis by Countries

Chapter 9: Middle East and Africa Whole Exome Sequencing Market Analysis by Countries

Chapter 10: South America Whole Exome Sequencing Market Analysis by Countries

Chapter 11: Global Whole Exome Sequencing Market Segment by Types

Chapter 12: Global Whole Exome Sequencing Market Segment by Applications

Check Complete Table of Contents @ https://www.databridgemarketresearch.com/toc/?dbmr=global-whole-exome-sequencing-market

Key Coverage in the Whole Exome Sequencing Market Report

Detailed analysis of Global Whole Exome Sequencing Market by a thorough assessment of the technology, product type, application, and other key segments of the report

Qualitative and quantitative analysis of the market along with CAGR calculation for the forecast period

Investigative study of the market dynamics including drivers, opportunities, restraints, and limitations that can influence the market growth

Comprehensive analysis of the regions of the Whole Exome Sequencing industry and their futuristic growth outlook

Competitive landscape benchmarking with key coverage of company profiles, product portfolio, and business expansion strategies

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Whole Exome Sequencing Market Projected to Reach CAGR of 19.0% Forecast by 2029, Global Trends, Size, Share, Growth, Future Scope and Key Player...

Clifford has a background in materials engineering, worked for Teck as an undergrad student on a co-op doing corrosion studies on base metals, and became an expert on functional coatings for biomaterials.

Copper alloy surfaces are naturally antimicrobial with self-sanitizing properties, and research showed these surfaces eliminate up to 99.9% of harmful bacteria and viruses but there was a lag time in killing gram positive bacteria and that was the challenge to overcome.

My idea was for copper it has one limitation that it kills gram positive more slowly, if we could change the surface chemistry, the topography or roughness, we can kill bacteria more quickly, Clifford told MINING.com.

One way we can do this, is copper is antimicrobial because its actually corroding very slowly, so its not copper in a zero state oxidation thats antimicrobial, its positively charged copper ions that kill bacteria.

The Coptek covid killing copper coating that has been deployed at most of the Applied Science buildings on the UBC campus and at the British Columbia Institute of Technology was funded by Tecks Copper & Health program. The formula came from the surface engineering Dr. Clifford and her research team Dr. Edouard Asselin, Dr. Elizabeth Bryce, and Dr. Marthe Charles developed a collaboration between the Department of Materials Engineering and the Faculty of Medicine at the University of British Columbia.

The study was published inJuly in Advanced Materials Interfaces.

What the team did to mitigate the lag time in killing bacteria with pure copper while its corrodes or oxidizes, was couple two dissimilar metals, in this case zinc, which due to the different reduction potential corrodes first.

That gets things going its spontaneous, the zinc will just start corroding and then the copper will corrode. It got everything going and we got a lot better results. Another thing we did was add nano-scale roughness, Clifford said.

That idea came from knowing that certain insects and reptiles skins have nanoscale roughness, which are naturally anti-bacterial.

For our coating we took copper and zinc and added this nanoscale roughness, and now all of a sudden its overcoming the issue of killing gram positive bacteria slowly and now its killing 99.7% within an hour, so half the time, Clifford said.

The coating could significantly reduce the incidence of contracting bacterial infections from high-touch surfaces in healthcare facilities and other public spaces.

The next phase is to do a trial in hospitals where the germ killing copper could have the most impact. Clifford said the strategy is to combat antibiotic resistance which can lead to superbugs afflicting patients who are already sick.

Part of that is decreasing the overall amount of pathogens and antibiotic resistant bugs that are already in public spaces, so this coating has that.

The team is still studying how the coating works on other viruses in the hopes of making a bigger impact.

Almost all the principles that were used to make this medical innovation were just pure metallurgical engineering applied to a medical application, Clifford pointed out.People who think that metallurgical mining engineering has a very niche application the tools that you learn you can also apply to other applications such as medicine.

Clifford didnt realize the idea she had walking home from the subway that winter day would be developed to the point where it would be deployed on university campuses and next in hospitals.

As an academic you can make educated guesses, she said.

I thought it would work, and it did.

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Another 'Dr. Copper' - MINING.COM - MINING.com

Doctor of Optometry Ron Kleinman, left, performs an eyesight prescription test on patient Gloria McKinney at the Remote Area Medical (RAM) clinic inside the Los Angeles Sports Arena.

(The Center Square) Health officials and optometrists are calling on Gov. Gavin Newsom to sign a bill on his desk that would allow qualified optometrists to perform certain advanced procedures, a measure supporters say will improve access to eye care for all Californians.

Assembly Bill 2236,sponsored by Assemblymember Evan Low, would allow optometrists who are certified to treat glaucoma to perform certain other advanced procedures if they meet other education and training requirements.

Specifically, the bill would allow optometrists who complete additional certifications and training to use certain types of lasers for treatment and remove skin tags or non-cancerous lesions that are smaller than five millimeters.

The bill comes as Californians across the state are waiting months for specialty eye care treatment, as ophthalmology care can be difficult for many patients to access. Thirteen out of Californias 58 counties have no ophthalmologists, six counties have just one ophthalmologist and two counties have two ophthalmologists, according to a news release from the California Optometric Association.

Health officials say it will help address the crisis level of limited specialty eye care and increase access to treatment for many Californians by authorizing optometrists who receive additional training and certification to perform minimally invasive procedures.

We have the pieces in place to increase access optometrists are out there, optometrists are willing, optometrists are trained, Jeffrey Garcia, optometrist and member of the California State Board of Optometry, told reporters Thursday. We just need the governor to sign this bill to give us that opportunity.

Garcia, who practices in Kings County in Californias central valley, said it is extremely hard for patients to access ophthalmology care, particularly Medi-Cal beneficiaries. Garcia said Kings and Tulare counties have no ophthalmologists that accept Medi-Cal, which leaves one ophthalmologist who accepts Medi-Cal in Fresno County to see over 600,000 patients within their health service area.

If Newsom signs this bill, California will join 10 other states that allow optometrists to use lasers and 17 other states that authorize them to remove skin tags. Officials said Thursday that optometrists in other states are already performing all procedures included in the bill.

The bill was opposed by the California Medical Association as it moved through the legislature, despite amendments taken to require optometrists seeking certification for advanced procedures to complete at least 43 complete surgical procedures on live human patients.

While the latest amendments increase the number of required surgeries to 43, that number is far below the clinical education requirements of ophthalmology residency programs, CMA wrote in opposition.

Supporters contend, however, that the law would implement the nations strictest standards for the training and certification of optometrists before they can perform these procedures, John Flanagan, dean of the Herbert Wertheim School of Optometry & Vision Science at UC Berkeley, told reporters.

The bottom line is that AB 2236 will help patients access the care they need, Flanagan said. As the dean of UC Berkeleys optometry school, I can say confidently that the training measures in the bill protect the quality and safety of that care.

Supporters of AB 2236 said Thursday they are hopeful the bill will earn Newsoms signature. The measure is among hundreds of bills currently sitting on Newsoms desk with a Sept. 30 deadline to be signed.

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Optometrists call on Newsom to sign bill to expand eye care - HDDailyNews

GENEVA (7 September 2022) Independent UN experts* said today that profound concerns over systematic human rights violations and their widespread effect on individuals and minorities in Chinas Xinjiang Uyghur Autonomous Region cannot, and should not, be ignored by the international community. They repeated a call for the Human Rights Council to convene a special session on China.

In supporting the recently released assessment by the UN Human Rights Office on allegations of abuses in Xinjiang, the experts highlighted the conclusion from the assessment that the extent of arbitrary and discriminatory detention of members of Uyghur and other predominantly Muslim minorities may constitute international crimes, in particular crimes against humanity. They also drew attention to the reports findings of credible allegations of patterns of torture or ill-treatment, including forced medical treatment and adverse conditions of detention, as well as incidents of sexual and gender-based violence including invasive gynaecological exams, and indications of coercive enforcement of family planning and birth control policies.

The experts described the assessment, released on 31 August 2022, as comprehensive and principled, adding that it built on and backed the findings and views of multiple Special Procedure mandate holders and Working Groups.

The experts welcomed the attention given in the report to widespread misuse of counter-terrorism and counter-extremism laws, policies and practice.

The experts are particularly concerned that both UN human rights mechanisms in tandem with this assessment demonstrate that: Chinas policies and practices have limited the legitimate exercise of the right to freedom of religion or belief, the right to family life including reproductive rights for women, freedom of opinion and expression, the right to assemble and associate peacefully, the right to privacy, the right to cultural life, and the right to live free from arbitrary detention, forced labour as well as freedom from any violation of the right to life and from torture, inhuman and degrading treatment and from enforced disappearance as well as the right of religious and ethnic minorities to enjoy their own culture, to profess and practice their own religion, or to use their own language.

The experts said they endorse and support all the recommendations made by the UN Human Rights Office and offer their support to facilitate the implementation of these recommendations. They called on the Government to invite mandate holders and affirmed their availability to undertake country visits, as well as to provide technical assistance and support to the Government.

The experts also reiterated recommendations made in their June 2020 joint statement, urging the Human Rights Council to hold a special session to address human rights issues more broadly in China precisely because key issues of concern, especially arbitrary detention, enforced disappearances, restrictions to movement, privacy, freedom of religion, freedom of expression are occurring in other parts of the country premised on grounds of national security. The Human Rights Council should urgently consider the creation of a Special Procedures mandate, or a panel of experts to closely monitor, analyse and report annually on the human rights situation in China; the General Assembly or Secretary-General should consider the creation of a special envoy; and they urge UN Member States and UN agencies and business enterprises to demand that China fulfils its human rights obligations, including during their ongoing dialogues with the Government.

ENDS

The experts: Fionnuala N Aolin,Special Rapporteur on the promotion and protection of human rights while countering terrorism;Alice Edwards, Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, Siobhn Mullally, Special Rapporteur on trafficking in persons, especially women and children; Clment Nyaletsossi Voule,Special Rapporteur on the rights to freedom of peaceful assembly and of association; Balakrishnan Rajagopal, Special Rapporteur on adequate housing as a component of the right to an adequate standard of living, and on the right to non-discrimination in this context; Attiya Waris,Independent Expert on the effects of foreign debt and other related international financial obligations of States on the full enjoyment of all human rights, particularly economic, social and cultural rights; Tomoya Obokata, Special Rapporteur on contemporary forms of slavery, including its causes and consequences; Luciano Hazan (Chair-Rapporteur), Aua Bald (Vice Chair), Grayna Baranowska, Gabriella Citroni and Angkhana Neelapaijit,Working Group on Enforced or Involuntary Disappearances; Ana Brian Nougrres,Special Rapporteur on the right to privacy; Tlaleng Mofokeng, Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health; Miriam Estrada-Castillo(Chair-Rapporteur),Mumba Malila(Vice-chairperson),Elina Steinerte, Priya Gopalan,Matthew Gillett,Working Group on arbitrary detention;Nazila Ghanea,Special Rapporteur on freedom of religion or belief; Reem Alsalem, Special Rapporteur on violence against women and girls, its causes and consequences; Fernand de Varennes, Special Rapporteur on Minorities Issues; Sorcha MacLeod(Chair-Rapporteur), Jelena Aparac, Ravindran Daniel, Chris Kwaja, Carlos Salazar Couto,Working Group on the use of mercenaries; Irene Khan,Special Rapporteur on the promotion and protection of the right to freedom of opinion and expression; Melissa Upreti(Chair),Dorothy Estrada Tanck(Vice-Chair),Elizabeth Broderick,Ivana Radai, andMeskerem Geset Techane,Working Group on discrimination against women and girls; Tendayi Achiume, Special Rapporteur on contemporary forms of racism, racial discrimination, xenophobia and related intolerance; Alexandra Xanthaki, Special Rapporteur in the field of cultural rights; Farida Shaheed, Special Rapporteur on the right to education; Claudia Mahler Independent Expert on the enjoyment of all human rights by older persons; Morris Tidball-Binz,Special Rapporteur on extrajudicial, summary or arbitrary executions; Fabin Salvioli, Special Rapporteur on the promotion of truth, justice, reparation and guarantees of non-recurrence; Fernanda Hopenhaym(Chairperson), Elbieta Karska,Robert McCorquodale,Damilola OlawuyiandPichamon Yeophantong (Vice-Chairperson),Working Group on Business and Human Rights; Michael Fakhri, Special Rapporteur on the right to food.

The Special Rapporteurs, Independent Experts and Working Groups are part of what is known as theSpecial Proceduresof the Human Rights Council. Special Procedures, the largest body of independent experts in the UN Human Rights system, is the general name of the Councils independent fact-finding and monitoring mechanisms that address either specific country situations or thematic issues in all parts of the world. Special Procedures experts work on a voluntary basis; they are not UN staff and do not receive a salary for their work. They are independent from any government or organization and serve in their individual capacity.

UN Human Rights, country page China

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Xinjiang report: China must address grave human rights violations and the world must not turn a blind eye, say UN experts - OHCHR

PDUFA Action Date is June 28, 2023

VAUGHAN, Ontario and HEIDELBERG, Germany, Sept. 6, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

"With the FDA commencing review of the NDA filing, we are one step closer to bringing an important new treatment option to the millions of Americans affected by dry eye disease associated with Meibomian gland dysfunction," said Joseph C. Papa, CEO, Bausch + Lomb. "NOV03 is distinct from anti-inflammatory and immunomodulatory agents, and, if approved, would be the first prescription eye drop to address excessive tear evaporation. The approval would also mark a significant milestone for Bausch + Lomb, as the company's first FDA approval for a prescription medicine since becoming a publicly traded company earlier this year."

DED is one of the most common ocular surface disorders, with MGD as a major cause of development and progression, affecting approximately nine out of 10 people with DED.1,2 DED due to MGD is caused by a deficient tear film lipid layer that leads to increased tear evaporation.3 There is currently no approved prescription eye drop in the United States for DED associated with MGD.

"We are thrilled the FDA has accepted our NDA filing for NOV03," said Christian Roesky, Ph.D., CEO, Novaliq. "With only limited treatment options currently available, NOV03 is a promising potential new therapy, specifically designed to alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction."

The clinical development program for NOV03 includes two Phase 3 studies (GOBI and MOJAVE), both of which demonstrated statistically significant improvement vs. control for both primary and key secondary sign and symptom endpoints as early as day 15 and through day 57. NOV03 was well tolerated in both studies.

About NOV03 (perfluorohexyloctane) Ophthalmic SolutionNOV03 (perfluorohexyloctane) is an investigational, proprietary, water-free, non-steroidal, single-component preservative-free eye drop.4In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 inthe United StatesandCanada.Data from the first pivotal Phase 3 trial (GOBI) were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C. on April 24, 2022. Data from the second pivotal Phase 3 trial (MOJAVE) were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022. Results from the pivotal Phase 2 trial (SEECASE) were published in Cornea in September 2021.5 The clinical program for NOV03 concluded with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).

About NovaliqNovaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases. NovaliqGmbH is headquartered inHeidelberg,Germanyand Novaliq Inc. has an office inCambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More onwww.novaliq.com.

About Bausch + LombBausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visitwww.bausch.comand connect with us on Twitter, LinkedIn, Facebook and Instagram.

Forward-looking StatementsThis news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb's filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

All product/brand names and/or logos are trademarks of the respective owners. 2022 Bausch & Lomb Incorporated or its affiliates.NOV03.0016.USA.22

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SOURCE Bausch + Lomb Corporation

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Bausch + Lomb and Novaliq Announce U.S. FDA Filing Acceptance for Investigational Treatment NOV03 (Perfluorohexyloctane) - BioSpace

A research team led by the Department of Ophthalmology, School of Clinical Medicine, LKS Faculty of Medicine of The University of Hong Kong (HKUMed), with collaborators from the Faculty of Medicine of The Chinese University of Hong Kong (CU Medicine) and local and international partners, have developed a new technology ROTA (Retinal nerve fibre layer Optical Texture Analysis) to unveil the optical texture and trajectories of the axonal fibre bundles on the retina. ROTA outperforms the current clinical standards, attaining 15.0% to 28.4% higher in sensitivity in detecting early optic nerve damage in glaucoma the leading cause of irreversible blindness. The research has been published in Nature Biomedical Engineering1[link to publication].

BackgroundGlaucoma is the most common form of neurodegenerative disease. Whereas clinical diagnosis of glaucoma is predicated on the measurement of retinal nerve fibre layer (RNFL) thickness, typically obtained with a non-invasive digital imaging device, optical coherence tomography (OCT)2, false positives and false negatives are common, which renders clinical interpretation of OCT findings difficult, even for glaucoma specialists. This is supported by a meta-analysis reporting that the sensitivities of best-performing OCT parameters for detection of RNFL thickness abnormalities were only 65%-75% at specificities of 90%-95%3.

Research findings and significanceROTA is a patented algorithm (US Patent No. 10,918,275)4that integrates RNFL thickness and RNFL reflectance measurements obtained from standard OCT scans to discern the optical texture and trajectories of the axonal fibre bundles and reveal RNFL defects. ROTA can detect focal RNFL defects that are missed by standard clinical tests. Compared with OCT, ROTA can increase the sensitivity of detecting early optic nerve damage in glaucoma by 15-22%. At 95% specificity, the sensitivity of ROTA was 97.3-98.4% for detection of early glaucoma, 15.0% to 28.4% higher than the current clinical standards. HKUMed is working with the University of California San Diego (UCSD), the United States, to apply ROTA in research and patient care, while patients can find the application of ROTA at HKU Eye Centre and Southern District Hong Kong Eye Survey.

In a diagnostic study examining 177 healthy individuals and 363 glaucoma patients at the CUHK Eye Centre of CU Medicine, ROTA attained significantly higher sensitivity and specificity than conventional OCT RNFL thickness analysis to detect glaucoma1. Furthermore, ROTA is able to identify axonal fibre bundle damage in optic neuritis, ischemic optic neuropathy, and compressive optic neuropathy.

We are delighted to have worked with CU Medicine to develop ROTA, which brings new hope to early identification and timely treatment of glaucoma due to its high sensitivity and specificity, said Professor Christopher Leung Kai-shun, Chairperson and Clinical Professor of the Department of Ophthalmology, School of Clinical Medicine, HKUMed. Our next steps include enrolling patients from Queen Mary Hospital, Grantham Hospital, and Hong Kong Eye Hospital for longitudinal studies to examine the effectiveness of ROTA for detection of glaucoma progression, as well as working with OCT industrial partners to deploy ROTA in clinical care. Furthermore, HKU Eye Centre welcomes patients with questionable diagnosis of glaucoma for ROTA assessment.

Professor Clement Tham Chee-yung, Chairman of the Department of Ophthalmology and Visual Sciences and S.H. Ho Professor of Ophthalmology and Visual Sciences, CU Medicine, remarked, Glaucoma can lead to irreversible loss of vision, if it is not diagnosed and treated early. In Hong Kong, about 25% of irreversible blindness is caused by glaucoma, and there are more about 100,000 glaucoma patients suffering from various levels of visual disability. Achieving earlier diagnosis of glaucoma and detection of progression through advanced imaging technologies is essential. I am glad that ROTA was developed by CU Medicine and HKUMeds collaboration and now it can be used in clinical practice.

Clinical applicationsROTA underpins a highly sensitive and specific technique to advance the diagnosis of glaucoma and optic neuropathies. ROTA will be deployed on the Advanced Nerve and Glaucoma Imaging Network (ANGI Network), which comprises ophthalmologists, neuro-ophthalmologists and clinical researchers around the world. The committee members of ANGI Network include world-leading institutions in glaucoma research such as HKU, Asan Medical Center (Korea), Beyer Eye Institute at Stanford University (US), Moorfields Eye Hospital (UK), NTU Langones Eye Center (US), and University College London (UK).

About the research teamThis research was directed by Professor Christopher Leung Kai-shun, Chairperson and Clinical Professor of the Department of Ophthalmology, School of Clinical Medicine, as well as Director of HKU Eye Centre, HKUMed, the corresponding author of the study, and Dr Alexander Lam Ka-ngai, Research Officer of the Department of Ophthalmology, School of Clinical Medicine, HKUMed. Co-authors include Dr Carol Cheung Yim-lui, Associate Professor; Dr Kelvin Wan Ho-nam, Clinical Assistant Professor (Honorary); Dr Mandy Wong, Clinical Assistant Professor (Honorary); Dr Carmen Chan, Clinical Associate Professor (Honorary); Dr Noel Chan, Clinical Assistant Professor (Honorary); Dr Kam Ka-wai, Clinical Assistant Professor (Honorary) and Dr Lin Chen from the Department of Ophthalmology and Visual Sciences at CU Medicine; Professor Robert N. Weinreb, Chair and Distinguished Professor of the Department of Ophthalmology at UCSD; Professor Ted Garway-Heath, IGA Professor of Ophthalmology at the UCL Institute of Ophthalmology; Dr Marco Yu from Singapore Eye Research Institute; Philip Guo Yawen, Vivian Chiu and Gilda Lai from the Department of Ophthalmology, School of Clinical Medicine, HKUMed.

AcknowledgementsThe research was supported by the General Research Fund (14101518), Hong Kong University Grants Committee and the Technology Start-up Support Scheme for Universities (2019-2020), Hong Kong Innovation and Technology Commission.

Media enquiriesPlease contact LKS Faculty of Medicine of The University of Hong Kong by email (medmedia@hku.hk).

1Leung CKS, Lam AKN, Weinreb RN, Garway-Heath DF, Yu M, Chiu V, Wan K, Wong M, Wu K, Cheung CY, Lin C, Chan C, Chan NC, Kam KW, Lai G. Diagnostic assessment of glaucoma and non-glaucomatous optic neuropathies via Retinal nerve fiber layer Optical Texture Analysis. Nature Biomedical Engineering Published 2022;6(5):593-604.

2Weinreb RN, Leung CK, Garway-Heath DF, Medeiros FA, Liebmann J. Consensus series 8 Diagnosis of primary open angle glaucoma (Kugler Publications, 2016).

3Oddone F, Lucenteforte E, Michelessi M, et al. Macular versus Retinal Nerve Fiber Layer Parameters for Diagnosing Manifest Glaucoma: A Systematic Review of Diagnostic Accuracy Studies. Ophthalmology. 2016;123:939-49.

4Leung CKS, Lam AKN. Optical Texture Analysis of the Inner Retina (US20190110681).

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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A new technology ROTA developed by HKUMed and CU Medicine can visualise axonal fibre bundles on the retina to advance early diagnosis of glaucoma and...

SOUTH SAN FRANCISCO, Calif., Sept. 11, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients (ClinicalTrials.gov Identifier: NCT03947385).

"The confirmed partial responses and high percentage of patients with tumor shrinkage shown in these interim Phase 2 data are extremely encouraging for patients with metastatic uveal melanoma. The 50% overall response rate and greater than 5 months median progression free survival observed in first-line MUM patients reflects the potential for a compelling clinical efficacy profile irrespective of haplotype (HLA-A*02:01) status. The partial responses shown in first-line and any-line MUM patients are clinically significant and build on previously-reported results for any-line MUM patients, now with a larger patient data set," said Dr. Marlana Orloff, M.D., Associate Professor, Sidney Kimmel Cancer Center, Jefferson Health.

"The clinical efficacy observed in first-line patients in these interim Phase 2 data presents an opportunity to pursue a front-line strategy and provides a rationale for a potential registration-enabling clinical trial in MUM," said Dr. Matt Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, IDEAYA Biosciences.

There are currently no FDA approved therapies for GNAQ and GNA11 solid tumors, and current therapies for MUM have relatively low objective response rates and short median progression free survival (PFS), highlighting the high unmet medical need. Approximately 90% of MUM has either a GNAQ or GNA11 mutation that activates the protein kinase C (PKC) signaling pathway. The historical overall response rate (ORR) in MUM clinical trials has generally been reported with an ORR ranging from approximately 0 to 5%, including: pembrolizumab and tebentafusp (each ~5%); MEK inhibitor selumetinib in combination with dacarbazine (~3%); and cMET inhibitor cabozantinib monotherapy (~0%). In addition, the historical median PFS in MUM clinical trials has been reported ranging from approximately 2.0 to 2.8 months, including: tebentafusp (~2.8 months, IMCgp100-102 study); MEK inhibitor selumetinib in combination with dacarbazine (~2.8 months); and cMET inhibitor cabozantinib monotherapy (~2.0 months).

Darovasertib (IDE196) is a small molecule, potential first-in-class protein kinase C (PKC) inhibitor. IDEAYA is evaluating the synthetic lethal combination of darovasertib and crizotinib, a small molecule cMET inhibitor, in MUM and other GNAQ/11 tumors pursuant to a clinical trial collaboration and drug supply agreement with Pfizer.

Clinical Data Update Darovasertib and Crizotinib Combination in MUM The interim Phase 2 clinical data update is based on an initial thirty-seven (37) patients enrolled in the darovasertib and crizotinib combination study at the expansion dose of 300mg twice-a-day darovasertib and 200mg twice-a-day crizotinib, as of the data analysis cutoff date of June 26, 2022. Out of the thirty-seven (37) patients enrolled, there were thirty-five (35) evaluable patients and two (2) non-evaluable patients. The two (2) non-evaluable patients were both pretreated and withdrew from the trial prior to the first scan. Neither of the two non-evaluable patients progressed due to disease: one (1) patient withdrew consent and one (1) patient discontinued early due to fatigue. Reported data are preliminary and based on an unlocked database as of the data analyses cutoff date, except one confirmatory scan after the data cutoff date or as otherwise noted. Enrollment in the darovasertib and crizotinib combination expansion dose cohort of the clinical trial is ongoing.

The company observed encouraging clinical activity in Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients in the expansion dose cohort. These investigator-reviewed data by RECIST 1.1 include:

These data provide robust clinical proof-of-concept for the efficacy of the darovasertib and crizotinib synthetic lethal combination treatment.

The darovasertib and crizotinib combination therapy has a manageable adverse event profile in MUM patients (n=37), with a low rate of drug-related serious adverse events (SAE's). Patients reported predominantly Grade 1 or 2 drug-related adverse events: all patients experienced a drug-related AE, of which 76% were reported as Grade 1 or 2 and 24%were reported as Grade 3. No patients observed Grade 4 or Grade 5 AE's. One patient discontinued treatment due to a drug-related adverse event.

The potentially addressable patient population for metastatic uveal melanoma is estimated to include over 4,000 patients across US and Europe, based on estimated annual incidence. As an orally-administered small molecule precision medicine therapeutic, with demonstrated anti-tumor activity and manageable adverse event profile, the company considers the darovasertib and crizotinib combination therapy to have the potential to be broadly impactful to the MUM patient population.

IDEAYA is currently targeting to initiate a potential registration-enabling trial in Q1 2023. The company is evaluating first-line MUM as a potential registrational regulatory strategy. As of August 31, 2022, IDEAYA has enrolled 21 first-line MUM patients at the expansion dose of the darovasertib and crizotinib combination study.

Darovasertib (Neo)Adjuvant Uveal Melanoma and Other Potential Expansion OpportunitiesIDEAYA is also evaluating the potential for darovasertib in other oncology indications, including as (neo)adjuvant therapy in primary uveal melanoma (UM), in cMET-driven tumors and in KRAS-mutation tumors.

(Neo)Adjuvant UM represents a significant expansion opportunity for darovasertib with a potential annual incidence of approximately 8,700 patients aggregate in US and Europe.

The company has observed preliminary proof of concept for potential darovasertib use in the (neo)adjuvant uveal melanoma setting, including responses of the primary orbital tumor. Clinical data reflects an observed tumor shrinkage by investigator review of primary ocular lesions in 5 of 5 (100%) UM or MUM patients treated as monotherapy or in combination with Crizotinib, including preliminary observation of tumor reductions in uvea lesion of two patients after the data cut-off date of August 19, 2022:

"I am excited to explore the potential for darovasertib as a (neo)adjuvant approach for the treatment of uveal melanoma patients. The observed clinical experience provides a basis for clinical investigation to evaluate whether darovasertib, can improve current primary treatment paradigms, which typically include radiotherapies and/or enucleation of the eye," said Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Oncology Site Lead at Princess Margaret Cancer Centre inToronto,Canada, and Ocular Melanoma Physician Task Force ofCanadaCo-Lead.

IDEAYA is supporting St. Vincent's Hospital Sydney Limited, which has initiated an Investigator Sponsored Trial, or IST, captioned as the "Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM) study, to evaluate darovasertib monotherapy in a neo-adjuvant and adjuvant setting in primary UM patients. IDEAYA is targeting initiation of a company-sponsored clinical trial in Q4 2022 to further evaluate darovasertib monotherapy in (neo)adjuvant uveal melanoma, and is evaluating potential near-term clinical endpoints such as vision and organ preservation.

IDEAYA Investor Webcast and Conference CallIDEAYA will host an investor webcast and conference tomorrow morning, September 12, 2022 at 8:00 am ET, to present darovasertib and crizotinib Phase 2 interim clinical efficacy and tolerability data, as well as clinical landscape, potential registrational strategies and expansion opportunities.

Presenters at the investor webcast and conference call will include Dr. Marlana Orloff, M.D., Associate Professor, Sidney Kimmel Cancer Center, Jefferson Health, and Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Oncology Site Lead at Princess Margaret Cancer Centre inToronto,Canada, and Ocular Melanoma Physician Task Force ofCanadaCo-Lead, each of whom are key opinion leaders and clinical investigators. Yujiro S. Hata, President and Chief Executive Officer, and other members of the IDEAYA management team will also present.

IDEAYA's darovasertib investor webcast presentation, as well as an updated corporate presentation, will be available on the company's website, at its Investor Relations portal (https://ir.ideayabio.com/) in advance of the investor webcast presentation at approximately 6:00 am ET.

Corporate UpdatesIDEAYA had cash, cash equivalents and marketable securities of approximately $324 million as of June 30, 2022, which it currently projects will be sufficient to fund its planned operations into 2025.

About IDEAYA BiosciencesIDEAYA is a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality which represents an emerging class of precision medicine targets.

Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to (i) timing for initiating potential registration-enabling trial in MUM, (ii) potential clinical efficacy profile, and (iii) timing of initiation of a company-sponsored clinical trial for in Q4 2022 to further evaluate to evaluate darovasertib in a neo-adjuvant and adjuvant setting in primary UM patients. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, the ongoing military conflict between Russia and Ukraine, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Quarterly Report on Form 10-Q filed on August 15, 2022 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

SOURCE IDEAYA Biosciences, Inc.

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IDEAYA Reports Positive Interim Phase 2 Clinical Results for Darovasertib and Crizotinib Synthetic Lethal Combination in Metastatic Uveal Melanoma -...

Biotechnology engineering is an undergraduate degree programme in applied sciences that amalgamates the facts from both Biological sciences and technology. This study utilizes the biological processes which include the study of microorganisms or knowledge of antibiotics and further implement them in various industrial purpose.

In simple terms, Biotechnology is a study which involves the use of living organisms. The living organisms are used to make useful chemicals which can be utilized in industries. Biotechnological products are used in areas like agriculture, food sciences and medicine.

Biotechnology engineers tend to work with a broad range of medical, technical and admin professionals. The key skillsets include:

The minimum eligibility criteria required in order to pursue a BTech programmein Biotechnology states that a candidate should have completed their + 2 education with PCB. While there are engineering institutes that consider Mathematics a compulsory subject in order to offer admissions to candidates, institutes like JNU does not make maths mandatory for seeking admissions into the BTech in Biotechnology programmes. Candidates who have studied Biology in +2 can also apply for admissions.

The syllabus and course curriculum for BTech in Biotechnology vary for each university. However, we have enlisted a general list of topics included in the course programmes.

Subjects

Topics

Objective

Inorganic chemistry

Chemical bonding

Acids and Bases

Catalysis

Polymers

Colloids

This course introduces the concepts of inorganic chemistry.

Foundation course in physics

Interference by the division of wavefront

Diffraction

Polarization

Introduction to lasers

Fibre optical

This course is designed to provide fundamental knowledge of theories and concepts in physics.

Life sciences

Origin of life

Histology

Nutrition

Energy utilization

This course focuses on the discipline of Life Sciences and concepts related to it.

Essential in mathematics

Algebra of matrices

Quadratic forms

Mean value theorems

Partial derivatives

Mathematics is an essential part of the core curriculum for engineering courses.

Concepts in biotechnology

Introduction to biotechnology

Protein structure and engineering

Plant cell culture

This course introduces to the discipline of biotechnology and explains some of the basic concepts of biotechnology.

Introduction to computers

Introduction

Data storage

Programming using C

In this course, students learn the basics of computer and programming languages.

Foundation course in organic chemistry

Electronic displacements

Reactive intermediaries

Stereochemistry

Organic Chemistry is an important subject in Biotechnology. This course explains the basic ideas in organic chemistry.

Life sciences

Coordination and control

Homeostasis

Asexual reproduction

This course intends to study Life Science in a broader horizon.

Electric sciences

Properties of conductor and insulators

Alternating currents

Measuring instruments

Transformers

This paper focuses on the basic concepts of electronics and electrical science.

Microbiology

Microbes in human life

Functional anatomy

Microbial growth

Microbiology is another important paper for Biotechnology. It introduces topics and concepts of microbiology.

Bioenergetics

Biochemical evolution

Carbohydrates

Nucleic acids

Lipids

This course focuses on the study of energy flow through living systems.

Cell biology

Cell

Nucleus

Cell signalling

Cell cycle and division

This course intends to study the structure and function of living cells.

Chemical engineering

Chemical equations

Hearts of solution

The flow of incompressible fluids

This course focuses on the basic concepts of chemical engineering.

Molecular biology

Structure and properties of nucleic acids

DNA replication

Gene mutation

This paper aims to study biological activity at the molecular level.

Enzyme technology

Introduction to enzymes

Specificity of enzymes

Immobilization of enzyme

Enzyme technology is a subfield of biotechnology. This course introduces the concepts and theories of this field.

Plant tissue culture

Cellular totipotency

Cell and suspension culture

Protoplast culture

Haploid culture

This course studies techniques used to maintain or grow plant cells, tissues or organs artificially in a lab.

Animal biotechnology

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Higher Education in India | Shiksha.com

On August 16, 2018, the NIH Director issued a statement describing a proposal to streamline the federal framework for oversight of gene therapy. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to eliminate duplicative review and reporting requirements for human gene transfer protocols. The statement also describes NIHs effort to refocus the role of the NIH Recombinant DNA Advisory Committee (RAC) to be closer to its original mandate a transparent forum for science, safety, and ethics of emerging biotechnologies. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

The charter of the NExTRAC reflects the shift in focus of the committee while embracing the continuity of this important advisory committee.

Federal Register Notice

Charter of the NExTRAC

NIH Directors Statement

Under the Poliscope Blog

NIH Guide to Grants and Contracts Notice

More here:
NIH Guidelines - National Institutes of Health

HSINCHU, Sept. 11, 2022 /PRNewswire/ --Brain Navi, the leading surgical robot manufacture in Taiwan, announced a strategic partnership with distributor, Medtreq Medical Equipment, to expand the distribution of the Surgical Navigation Robot, NaoTrac, throughout the region of GCC region, Jordan, Egypt plus other countries in the Middle East and Philippines, Indonesia, Malaysia, and Singapore which will be covered by Medtreq branch in Philippines.

NaoTrac, a CE-certified and local government approval neurosurgical navigation robot from Brain Navi Biotechnology, is embedding dissimilar technology named SMART Technology which combining the machine vision and in-house algorithm to perform robot-assisted surgery, to streamline surgical procedures with real-time imaging and minimal invasive outcomes.

"We are always scouting for the new technology to help as many people as we can. We have many neurosurgeons coming from Riyadh and some other territories keening and willing to learn more about this technology, and the NaoTrac from Brain Navi is one of them. We are always happy to partner with an innovative technology company," said Sherif Bayoumy, the General Manager of Medtreq Medical Equipment.

The collaboration and partnership between Brain Navi and Medtreq enables greater innovative outcome in the Middle East neurosurgery, such as Saudi Arabia, UAE, Egypt, Jordan, and some of the other countries on progressing, to streamline the surgical procedure, improve the surgical accuracy and pass-on knowledge to shorten the learning curves. "We seek strategic partners that can accelerate Brain Navi's growth mission. This partnership is a significant step toward scaling our business and getting more robot-assisted neurosurgery into the world," said Jerry Chen, the CEO of Brian Navi Biotechnology. "The collaboration between Metreq and Brain Navi is looking positive because we share the same mission to innovate with technologyto make the life bright. We truly believe that the collaboration between Brain Navi and Medtreq can maximum the value of both sides to bring the neurosurgery to the next level."

About Metreq Medical Equipment Bahrain

Medtreq Medical Equipment provides professional technical support and after-service to clients in the MENA region with a presence in Bahrain and GCC, Egypt, North Africa, Turkey, Europe, the United States (Medtreq Tenessee USA), and the Philippines, Singapore, Malaysia, and Indonesia. Medtreq is built on high values, principles, and social commitment to society and humanity.

About Brain Navi

Brain Navi Biotechnology is a leading Taiwanese surgical robotic company. We design and develop innovative navigation and robotic surgery technologies for surgeons to improve surgical accuracy. Brain Navi's exclusive Surface Mapping Auto-registration Technology (SMART) is a significant surgical robotic breakthrough that merges machine vision, robotics, and AI technology to achieve streamlined surgical procedures with real-time imaging and minimal invasive outcomes.

SOURCE Brain Navi Biotechnology Co., Ltd.

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Brain Navi Biotechnology Announced Partnership with Distributor, Medtreq Medical Equipment, to enter the Middle East and Egypt with NaoTrac...

LOS ANGELES, September 11, 2022--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of updated findings from the Phase II SUMMIT basket trial of neratinib for HER2 (ERBB2)-mutant, metastatic cervical cancer at the 2022 European Society for Medical Oncology (ESMO) Congress, currently taking place in Paris, France. The poster (#559P) entitled, "Neratinib in HER2-mutant, recurrent/metastatic cervical cancer: updated findings from the phase 2 SUMMIT basket trial," was presented by Claire F. Friedman, M.D., Melanoma and Immunotherapy Service, Memorial Sloan Kettering Cancer Center, on September 11 at 11:10 a.m. CEST.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220911005034/en/

The Phase II SUMMIT basket trial is an open-label, multicenter, multi-national study evaluating the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The cervical cancer cohort was comprised of 22 patients with persistent, recurrent, or metastatic cervical cancer and a HER2 mutation, as documented by institutional testing at a CLIA/CAP- (or regionally equivalent) certified laboratory. Patients were treated with neratinib monotherapy (240 mg/day); 22 patients (100%) had previously received platinum-based chemotherapy, 16 patients (73%) had prior bevacizumab, and 4 patients (18%) received prior pembrolizumab. Overall, the objective response rate was 18.2% (95% CI: 5.240.3%) and the clinical benefit rate was 45.5% (95% CI: 24.467.8%), which included 1 patient with a confirmed complete response, 3 patients with confirmed partial responses, and 6 patients with stable disease at equal or greater than 16 weeks. The median progression-free survival was 5.1 months (95% CI: 1.77.2 months). Among the 13 patients (59.1%) who had tumors with a highly activating HER2 S310F/Y mutation, 4 had confirmed responses.

Story continues

The safety profile observed in the neratinib-treated cervical cancer patients was consistent with that reported for neratinib monotherapy in HER2-amplified breast cancer. The most frequently observed treatment-related adverse event was any-grade diarrhea (n=18; 81.8%), which included 5 (22.7%) Grade 3 or higher diarrhea events. Diarrhea was manageable with anti-diarrheal prophylaxis and none of the diarrhea events resulted in dose reduction or treatment discontinuation.

"HER2 mutations are present in 5% of cervical cancers, most commonly in endocervical adenocarcinomas, and HER2 targeted therapy is a potential treatment option for patients whose cancer has grown after standard first lines of treatment, including platinum-based chemotherapy," said Dr. Friedman, an investigator of the study from Memorial Sloan Kettering Cancer Center. "Neratinib treatment has been effective against several HER2-mutant cancers and the observed durable responses and disease control in metastatic patients with HER2-mutant cervical cancer are extremely promising for patients."

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased to observe that treatment with neratinib led to durable response and effective disease control in patients with aggressive HER2-mutant cervical cancer and that the adverse event of diarrhea could be managed with prophylaxis. Improving the lives of our cancer patients is our foremost goal, and we are pleased to see the benefit that was provided to these patients in the SUMMIT trial."

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https://www.NERLYNX.com or 1-855-816-5421.

INDICATIONS:

NERLYNX (neratinib) tablets, for oral use, is a kinase inhibitor indicated:

As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

IMPORTANT SAFETY INFORMATION Regarding NERLYNX (neratinib) U.S. Indication:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade 2 diarrhea that occurs after maximal dose reduction.

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: The most common adverse reactions (reported in 5% of patients) were as follows:

NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.

NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

DRUG INTERACTIONS:

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids.

Strong CYP3A4 inhibitors: Avoid concomitant use.

P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.

Strong or moderate CYP3A4 inducers: Avoid concomitant use.

Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:

Please see Full Prescribing Information for additional safety information.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the development of Pumas product candidates. All forward-looking statements involve risks and uncertainties that could cause Pumas actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Pumas Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent reports. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220911005034/en/

Contacts

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500info@pumabiotechnology.com ir@pumabiotechnology.com

David Schull or Olipriya Das, Russo Partners, +1-212-845-4271david.schull@russopartnersllc.com olipriya.das@russopartnersllc.com

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Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib for HER2-Mutant, Recurrent/Metastatic Cervical Cancer...

SAN DIEGO--(BUSINESS WIRE)--Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, announced today that company management will participate virtually in the UBS Biotechnology Private Company Symposium, being held September 21-22, 2022. Pipeline will present a company overview and will conduct virtual one-on-one meetings with investors during the conference.

About Pipeline Therapeutics

Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair. The Company has a broad pipeline of programs to address multiple CNS disorders. Its flagship program, PIPE-307, has completed two Phase 1 clinical trials - a SAD/MAD study and a PET study - in healthy volunteers, and has received Investigational New Drug clearance from the Food and Drug Administration to initiate clinical development in relapsing-remitting MS patients.

For more information, please visit http://www.pipelinetherapeutics.com and engage with us on LinkedIn.

Link:
Pipeline Therapeutics to Participate in the UBS Virtual Biotechnology Private Company Symposium - Business Wire

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will present an overview of the Company at the hybrid H.C. Wainwright 24th Annual Global Investment Conference, which will be held September 12-14, 2022. The virtual presentation will be available for 30 days beginning at 7:00 a.m. EDT on September 12, 2022 on the Companys website at https://www.pumabiotechnology.com.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.

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Puma Biotechnology to Present at the H.C. Wainwright 24th Annual Global Investment Conference - Business Wire

Did you know Wilson Community College offers a two-year degree in biotechnology?

This field is designed to meet the ever-increasing demands for skilled lab technicians in a wide range of fields in biological and chemical technology. So if you find yourself interested in the sciences, this is a great option to explore. The program focuses on biological sciences, biochemistry and genetics.

The biotechnology program at WCC includes a diverse group of students, including traditional students, early college students and high school students. Biotechnology students attending the Wilson Academy of Applied Technology, one of our early colleges, not only earn a high school diploma, but they also get a two-year degree at the same time. And we also partner with the Sallie B. Howard School of Art & Science to provide biotechnology courses to juniors and seniors as part of the College and Career Promise program.

WCCs biotechnology instructor, Stephanie Winstead, has a degree in chemistry and has work experience in the pharmaceutical industry a win-win for our students. She knows firsthand the importance of and the need for skilled workers in this field.

After 17 years in the pharmaceutical industry, and as my career evolved from a training role to a more administrative role, I realized my passion was teaching, she said. While my career has changed, my goal is the same. I now have the opportunity to train personnel for the job they want, rather than training them for the job they have. I am committed to giving students the skills necessary to successfully gain employment in the biotech field upon graduation. I am incredibly thankful for the privilege of serving the needs of my community.

And to add to that, we just received some exciting news. The North Carolina Community College System just announced that it was awarded $16.4 million over three years in federal funding to implement the N.C. BioBetter project. This is part of the U.S. Economic Development Administration Phase 2 Build Back Better Regional Challenge spearheaded by the N.C. Biotechnology Center.

The funding, awarded to Wilson Community College and nine other community colleges in the state, will help strengthen our states life sciences manufacturing cluster by expanding training and helping promote career opportunities to underserved communities.

With careers in biotechnology, the skys the limit. Graduates are qualified in all kinds of industry and government, including research, manufacturing and sales, just to name a few. We work with some of our local industries like Merck & Co., Purdue Pharma, Fresenius Kabi, Mayne Pharma and Global Laboratory Services Inc. Side note: Global Laboratory Services is not pharma, but rather agricultural biotechnology. We have students doing work-based learning with the company as crop protection agents, and Global Laboratory Services has recently hired one of our biotech graduates with hopes to hire more. And we also have an apprenticeship program with GlaxoSmithKline in Zebulon.

But to be more specific, here are the different types of work available. Graduates will be able to do the following:

Monitor or measure manufacturing processes to identify ways to reduce losses, decrease time requirements or improve quality.

Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods or stability samples.

Interpret test results, compare them to established specifications and control limits and make recommendations on appropriateness of data for release.

Compile laboratory test data and perform appropriate analyses.

Complete documentation needed to support testing procedures, including data capture forms, equipment logbooks or inventory forms.

If youd like more information about the biotechnology program, contact Stephanie Winstead, biotechnology instructor, at swinstead@wilsoncc.edu, or Travis Flewelling at tflewelling@wilsoncc.edu or 252-246-1210. At #WilsonCC, we make Wilson work.

WHATS HAPPENING

Sept. 14 New student orientation.

Sept. 19 Community chorus practice at 7 p.m.

Sept. 24 WCC Car & Truck Show from 9 a.m. to 3 p.m.

Jessica Griffin is director of institutional advancement at Wilson Community College. She can be reached at jgriffin@wilsoncc.edu or 252-246-1271.

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WCC Corner: Interested in the sciences? How about biotechnology? - Restoration NewsMedia

New Jersey, United States, Sept. 4, 2022 /DigitalJournal/ Cellular reprogramming is the process of reverting mature and specialized cells into induced pluripotent stem cells. Reprogramming also refers to the erasure and resetting epigenetic marks during mammalian germ cell development. Stem cells are studied and developed in treatments for various ailments using cell reprogramming methods, as a method of replenishing cells damaged by disease. These cells are created from somatic cells, such as blood or skin cells, that have undergone genetic reprogramming to resemble embryonic stem cells to produce an endless supply of a wide variety of human cells for therapeutic purposes.

The Cell Reprogramming Market research report provides all the information related to the industry. It gives the markets outlook by giving authentic data to its client which helps to make essential decisions. It gives an overview of the market which includes its definition, applications and developments, and manufacturing technology. This Cell Reprogramming market research report tracks all the recent developments and innovations in the market. It gives the data regarding the obstacles while establishing the business and guides to overcome the upcoming challenges and obstacles.

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Competitive landscape:

This Cell Reprogramming research report throws light on the major market players thriving in the market; it tracks their business strategies, financial status, and upcoming products.

Some of the Top companies Influencing this Market include:Allele Biotechnology, ALSTEM, Applied Biological Materials, Axol Bioscience, Creative Bioarray, DefiniGEN, Fujifilm Cellular Dynamics, Lonza, Mogrify, REPROCELL, Stemnovate, Thermo Fisher Scientific

Market Scenario:

Firstly, this Cell Reprogramming research report introduces the market by providing an overview that includes definitions, applications, product launches, developments, challenges, and regions. The market is forecasted to reveal strong development by driven consumption in various markets. An analysis of the current market designs and other basic characteristics is provided in the Cell Reprogramming report.

Regional Coverage:

The region-wise coverage of the market is mentioned in the report, mainly focusing on the regions:

Segmentation Analysis of the market

The market is segmented based on the type, product, end users, raw materials, etc. the segmentation helps to deliver a precise explanation of the market

Market Segmentation: By Type

Sendai Virus-based ReprogrammingmRNA ReprogrammingEpisomal ReprogrammingOthers

Market Segmentation: By Application

Research & Academic InstitutesBiotechnology & Pharmaceutical CompaniesHospitals & Clinics

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An assessment of the market attractiveness about the competition that new players and products are likely to present to older ones has been provided in the publication. The research report also mentions the innovations, new developments, marketing strategies, branding techniques, and products of the key participants in the global Cell Reprogramming market. To present a clear vision of the market the competitive landscape has been thoroughly analyzed utilizing the value chain analysis. The opportunities and threats present in the future for the key market players have also been emphasized in the publication.

This report aims to provide:

Table of Contents

Global Cell Reprogramming Market Research Report 2022 2029

Chapter 1 Cell Reprogramming 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 Cell Reprogramming Market Forecast

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Cell Reprogramming Market is Expected to Record the Massive Growth, with Prominent Key Players Allele Biotechnology, ALSTEM, Applied Biological...

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With one of the highest concentrations of high-quality startups in the world, Israel has built a global reputation, rightfully earning the nickname of 'startup nation'. Industries ranging from agriculture, technology, healthcare, and more, have benefitted from the immense levels of innovation coming from Israel. In an attempt to become self-reliant, Israel invested in infrastructure, education, and technology to empower innovative leaders and field experts to lead the charge in their respective industries.

Biotechnology is one of Israel's most dominant sectors, with life science companies raising nearly $7 billion in the last decade on the NASDAQ. Israel's clear prominence in this industry has led major companies such as Pfizer, GE, Johnson & Johnson and more, to build R&D centers and startup incubators in the country. Garnering recognition on a global scale, helping other countries solve their own problems, and cultivating innovation within its own borders have propelled Israel to the center of biotech, and this is just the beginning.

What sets Israel apart

In the healthcare sector, many countries have failed to update medical procedures, opting for traditional, outdated approaches that fail to optimize procedures and client experiences. Israel is setting a new standard by showcasing the value of innovation and technology in medicine. For instance, the Israel-based company Nanox, which uses AI to redefine the landscape in early medical detection, had the largest IPO of any young medical company in history in 2020. This is just one example of how Israel has fostered innovation in biotech.

There are many factors that play into Israel's ambitious successes in biotechnology, but top-notch education and high levels of R&D investment are two of the most notable. Israel spends roughly 6 per cent of its GDP on education, and its academic institutions foster creative learning, innovation and technology for their students at all levels.

With educated citizens, grand investments in R&D, and an ever-changing landscape of need, Israel is poised to serve as a leader in biotechnology for the foreseeable future. Global landscapes across several industries are changing thanks to Israel's commitment to cutting-edge advancements in biotech.

Advancing the future of meaty technology

As more consumers grow weary of the potential health risks, environmental impact, and animal cruelty aspect of eating meat, alternative options are taking form at a rapid pace. Aleph Farms is the world's first company to produce steaks from animal cells. Recently, they announced that will join the Agriculture Innovation Mission for Climate (AIM for Climate) as an Innovation Sprint Partner.

Aleph Farms sees cellular agriculture as a practical solution to the world's most urgent issues and is working on developing affordable cell growth media for cultivated meat production, as well as conducting groundbreaking experiments on cultivated meat in space.

Revolutionizing Spinal Cord Treatment

There are between 250,000 and 500,000 new spinal cord injuries each year, according to the World Health Organization (WHO). These injuries are largely irreversible, leaving patients with costly medical care needs, extensive therapy treatments, and not much hope. Cutting-edge biotechnology is being developed to offer patients treatment that could restore some of the lost function.

NurExone, an Israel-based biotechnology company uses exosome technology to deliver proprietary agents that have the potential to support nerve regeneration. NurExone's studies show that their technology can create significant functional improvements. In one of their studies, they showed how animals who were able to walk again due to their treatment. NurExone's technology has been shown to stimulate nerve regeneration all while being non-invasive something quite revolutionary. Although they are still early-on in their journey, NurExone is reigniting treatment approaches for spinal cord injuries (SCI). With the total market for spinal cord trauma expected to reach $3.04 billion by 2025, NurExone's is tackling a large issue and brining hope to SCI patients around the world.

Treating cancer with precision medicine

Every patient is different, and Imagene AI is making it possible to treat them as such. With digitized biopsy imaging, Imagene AI can offer real-time molecular analysis to cancer patients, reducing the normal lead time from two weeks to two minutes. This level of innovation is astounding, but Imagene AI takes it even further. With wide-scope treatment-response prediction, medical professionals can gain an understanding of how each patient's body will respond to a variety of treatment plans.

A recent investment round brought in $21.5 million, with $18.5 million coming from Oracle co-founder Larry Ellison, and his fellow investors Dr. David Angus and Eyal Gura. At only two years old, Imagene AI has already begun changing the landscape of cancer treatment.

Biotech innovation addresses humanity's biggest problems

With Israel, the hub of innovation, leading the charge, the future is bright for biotechnology and the impact it will have on the world. While many medical needs can be addressed with the right advancements in the industry, it is becoming more clear that igniting growth in the biotech industry will bring abundant benefits to many other industries that need to be propelled into the future.

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Israeli Companies Are Leading the Global BioTech Charge, Here's How And Why - Entrepreneur

OSLO, Norway, Sept. 09, 2022 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced that its Chief Executive Officer, Michael Engsig, and Chief Business Officer & Co-founder, Agnete Fredriksen, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Tuesday, September 13, 2022 at 11:00 a.m. ET / 5:00 p.m. CET and are available for 1:1 investor meetings.

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Nykode Therapeutics to present at H.C. Wainwright 24th Annual Global Investment Conference

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Orion Corporation: Acquisition of Own Shares 09.09.2022

New York, NY, and Tel Aviv, ISRAEL, Sept. 09, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today released the Nasdaq MarketSite interview between Moneta Advisory Group’s Managing Partner Marc LoPresti and CEO Gerald Commissiong, discussing the impact of Long COVID on the economy and how SARS-CoV-2 viral persistence is damaging population-level immunity leading to the rise of viral outbreaks such as MonkeyPox. A link to the interview can be found at: https://youtu.be/55pv1zKCDgI.

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Todos Medical CEO Discusses Long COVID Economic Impact with Moneta Advisory Managing Partner Marc LoPresti

GAITHERSBURG, Md., Sept. 09, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced that Kristi Jones, Chief Executive Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12 at 11:00 am ET.

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NexImmune to Present at the H.C. Wainwright 24th Annual Global Investment Conference