By Connor Lynch Pictured: A patient being examined by an eye doctor EyePoint Pharmaceuticals marked a major win Monday, with Phase II results of its anti-VEGF therapy for wet age-related macular degeneration showing comparable results to Regeneron’s Eylea on a less-frequent dosing regimen. Share prices jumped over 200% in premarket trading on the news that EYP-1901 had hit all primary and secondary endpoints in the DAVIO 2 trial. The trial was investigating EyePoint’s EYP-1901 therapy, an “investigational sustained delivery maintenance treatment” for wet age-related macular degeneration (AMD) that combines vorolanib, a selective tyrosine kinase inhibitor, with “bioerodible Durasert E,” an injectable drug delivery system. The study tested two doses of the therapy, both 2 mg and 3 mg in 160 patients, finding both met all of the primary and secondary endpoints. That included the primary endpoint of “statistical non-inferiority change in best corrected visual acuity,” compared to the control of ...
Eli Lilly cancer drug Jaypirca is closing 2023 the same way it started—with an FDA approval. The latest regulatory nod adds two additional types of blood cancers to the list of indications for the therapy. Friday’s accelerated approval for Jaypirca covers the treatment of adults with either chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The once-daily oral drug is a small molecule designed to block Bruton’s tyrosine kinase, or BTK, a cancer-driving enzyme. While other drugs already do this, Lilly’s molecule has an edge. The FDA based its decision on the results of an open-label, single-arm Phase 1/2 study in blood cancers that included more than 100 patients with CLL or SLL previously treated with at least two prior lines of therapy. Participants had received a median of five prior lines of therapy; the FDA said 77% of these patients had discontinued a BTK inhibitor after their cancer ...
Anthem Blue Cross and Blue Shield in Virginia has partnered with Aledade, a network of independent primary care practices, to improve access to value-based primary care for Medicaid members, the companies announced last week. Bethesda, Maryland-based Aledade helps independent practices, health centers and clinics engage in value-based care through data insights, policy expertise and contracting support. It works with more than 1,500 practices and community health centers across 46 states and the District of Columbia. Through the partnership, Anthem’s Medicaid members will have better access to primary and preventive care, including health screenings. Aledade and Anthem began working together last year with the insurer’s Medicare Advantage and commercially insured members. The partnership enables Aledade to bring value-based care — in which clinicians are paid based on the quality of care they deliver versus the volume of care they provide — to more than 80 practices, 15 health centers and 25 ...
BY SEAN WHOOLEY GE HealthCare (Nasdaq: GEHC)+ announced today that it entered into a joint commercialization agreement with AirStrip to distribute patient monitoring technology. AirStrip, a member of the Nantworks group of AI-driven companies, develops cardiology and patient monitoring solutions. These technologies offer data visualization technology through a proprietary, native mobile application. Clinicians can see clinical data on mobile devices and on the web with the AirStrip technology. Under the agreement, GE HealthCare now serves as the exclusive distributor of AirStrip cardiology and patient monitoring solutions in the U.S. The deal offers data visualization that healthcare systems can purchase together. GE HealthCare says that pairing its technology with AirStrip’s allows for remote collaboration. It enables clinicians to view patient data from a distance and view multiple patients on one screen by level of priority. The collaboration has a focus on streamlining and optimizing in-patient care solutions. “We are proud to ...
A new guide from Northeast Business Group on Health helps employers understand the challenges women face when it comes to cardiovascular disease, diabetes and obesity. It also recommends actions that employers can take to support women in their workforce. By MARISSA PLESCIA About 44% of women in the U.S. are living with a form of heart disease, and heart disease is the leading cause of death for women in the U.S. Making matters worse is the lack of knowledge about these stats: only 56% of women realize that heart disease is the number one killer for American women. Cardiovascular disease in the U.S. costs about $363 billion annually in direct and indirect costs (such as missed workdays). That’s why the Northeast Business Group on Health (NEBGH) released a free guide for employers on Thursday that is focused on cardiovascular disease, diabetes and obesity in women. New York City-based NEBGH is ...
As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. On Friday, Dec.1, the FDA granted accelerated approval to Lilly’s Jaypirca for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. Jaypirca, which is itself a BTK inhibitor, is now allowed following treatment with a BTK inhibitor and a BCL-2 inhibitor. The ability to help patients who have failed on a BTK inhibitor makes Jaypirca unique. The Lilly med is a non-covalent BTK inhibitor that binds to BTK by a mechanism different from existing covalent agents, namely AbbVie/J&J’s Imbruvica, AZ’s Calquence and BeiGene’s Brukinsa. “Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be ...
The University of Edinburgh, the University of Arts London, Silchar Medical College, Assam University and the Indian Institute of Technology Delhi have collaborated on a new UK-India research project, DOSA2, to help combat antimicrobial resistance (AMR). LifeArc, UK Research and Innovation, Economic Social Science Research Council, the Newton fund and the government of India’s Department of Biotechnology will fund and support the Diagnostics for One Health and User Driven Solutions for Antimicrobial Resistance (DOSA) project. Designated as one of the top ten global public health threats facing humanity by the World Health Organization, AMR occurs when bacteria, fungi and parasites change and adapt to antibiotics over time. Globally, urinary tract infections (UTIs) are the second leading cause of antibiotic consumption, often purchased over the counter in India, one of the highest human antibiotic-using countries in the world, and taken without medical supervision, contributing to the global issue of AMR. The ...
Cancer Research UK (CRUK), its innovation unit, Cancer Research Horizons, and Guardant Health have announced a collaboration to advance the development and precision of cancer detection and treatment. The mission-focused collaboration aims to accelerate the discovery and development of cancer drugs and diagnostics for patients. Affecting 20% of people in the UK, rare cancers are forms of cancer that can occur in unusual places in the body, requiring special treatment. Challenging to treat, rare cancer types include melanoma skin cancer, kidney cancer, brain tumours, non-Hodgkin lymphoma and pancreatic cancer. As part of the agreement, the parties will be able to discuss opportunities for collaboration to support CRUK’s research and development activities. In particular, the agreement will focus primarily on the charity’s clinical trials run by its Centre for Drug Development (CDD), including the DETERMINE trial, as well as other CRUK and Cancer Research Horizon research collaborations. The DETERMINE trial is ...
Several pharmaceutical industry advocacy and lobby organisations have bandied together to release a joint industry statement supporting the Declaration on Climate and Health released at the ongoing COP28 meeting. The joint statement is from associations in Europe, US, Canada, and Japan, like the Association of the British Pharmaceutical Industry (ABPI), European Federation of Pharmaceutical Industries and Associations (EFPIA), Pharmaceutical Research and Manufacturers of America (PhRMA), as well as The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) which represents over 90 pharmaceutical companies worldwide. The declaration highlights the negative impacts of climate change on health, and details objectives to ensure better health outcomes, such as implementing adaptation interventions against climate-sensitive disease and health risks. The aim of the declaration is to strengthen the implementation of policies to protect populations most vulnerable to the health impact of climate change. The COP 28 meeting is an international gathering of national leaders, regulators, ...
By Tristan Manalac Pictured: GSK building in Poznan, Poland/iStock, Wirestock GSK CEO Emma Walmsley on Thursday touted the smooth launch of its respiratory syncytial virus vaccine Arexvy and its strong potential for growth in the coming years. In an interview with Reuters, Walmsley said the British biopharma is “delighted” with the progress it has made in the RSV vaccine race with Pfizer. “We are delighted with the start of our RSV vaccine,” Walmsley said, adding that the company expects Arexvy “will be more than £1 billion in its first year, (it) has lots of headroom for growth.” GSK is positioning Arexvy to be its next blockbuster asset. The U.S. launch of the vaccine has so far reached three million of the more than 80 million adults over 60 at risk from RSV, according to Walmsley. Arexvy became the first FDA-approved RSV shot in May 2023 and is authorized for use ...
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