PharmaFocus Today – Page 270 – media

ImmunoGen’s ADC Elahere wins FDA priority review for ovarian cancer

The US Food and Drug Administration (FDA) has granted priority review for the full approval of the antibody drug conjugate, Elahere (mirvetuximab soravtansine-gynx) and has set a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024. Elahere was a central element in the $10.1bn ImmunoGen acquisition deal announced by AbbVie last week (30 November). AbbVie expects the acquisition to complete in mid-2024. Elahere is an antibody drug conjugate (ADC) that targets folate receptor alpha (FRα). In November 2022, it was granted accelerated approval as the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for patients who have received one to three prior systemic treatment regimens. The latest supplemental Biologics License Application (sBLA) for Elahere is supported by the data from the Phase III MIRASOL trial, which will allow for the accelerated approval to be converted to a full approval. ImmunoGen reported $105.2m in ...
- Source: drugdu
- 139
- December 7, 2023
As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs. Together, those meds will help the company deliver pharmaceutical sales growth of 5% to 7% between 2025 and 2030, the company said Tuesday. That phalanx of novel products will be essential as J&J’s longstanding immunology star, Stelara, nears its tumble over the patent cliff. Last year, the drug generated $9.7 billion and was J&J’s top product by sales. During an enterprise business review Tuesday, J&J laid out its expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast 10 or more drugs with peak sales potential of at least $5 billion, including cancer launches Talvey and Tecvayli, plus another 15-plus products with sales potential of at least $1 billion. The latter group of therapeutics ...
- Source: drugdu
- 120
- December 7, 2023
EC approves UCB’s Zilbrysq as generalised myasthenia gravis add-on therapy

The European Commission (EC) has approved UCB’s Zilbrysq (zilucoplan) as an add-on therapy for certain patients with generalised myasthenia gravis (gMG), a rare autoimmune disease with a global prevalence of 100 to 350 cases per one million people. The marketing authorisation, which specifically applies to adults who are anti-acetylcholine receptor (AChR) antibody-positive, makes Zilbrysq the first once-daily subcutaneous, targeted component 5 (C5) complement inhibitor for gMG. Patients with gMG can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty swallowing, chewing and talking, and life-threatening weakness of the muscles of respiration. UCB’s Zilbrysq inhibits complement-mediated damage to the neuromuscular junction through its targeted dual mechanism of action, the company said, adding that the therapy can be used simultaneously with intravenous immunoglobulin and plasma exchange without the need for supplemental dosing. The EC’s decision was supported by positive results from the late-stage ...
- Source: drugdu
- 136
- December 7, 2023
Global donors pledge over $777m to fight neglected tropical diseases at COP28 summit

At the 2023 Reaching the Last Mile (RLM) Forum during the United Nations Climate Change Conference (COP28), global donors pledged $777.2m to help control, eliminate and eradicate neglected tropical diseases (NTDs). The funding will accelerate progress towards achieving the goals outlined in the World Health Organization’s (WHO) 2030 roadmap on NTDs. The forum, hosted by RLM in partnership with the Bill & Melinda Gates Foundation, comprised over 450 government ministers, global health leaders and development experts, philanthropists and civil society leaders to mitigate the effects of the climate crisis on human health. Established in 2020, WHO’s roadmap for NTDs includes eliminating at least one NTD in 100 countries by 2030 and reducing the number of people requiring NTD treatment by 90%. Despite progress, climate change has slowed the reach and prevalence of infectious diseases. NTDs are a diverse group of several parasitic viral, bacterial, fungal and non-communicable diseases that can ...
- Source: drugdu
- 130
- December 7, 2023
EyePoint Pharma Stock Surges on Phase II Wet AMD-Therapy Results

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 ...
- Source: drugdu
- 143
- December 6, 2023
Elli Lilly Cancer Drug Lands Its Second FDA Approval This Year

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 ...
- Source: drugdu
- 160
- December 6, 2023
Aledade, Anthem Form New Value-Based Medicaid Partnership for Virginians

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 ...
- Source: drugdu
- 123
- December 6, 2023
GE HealthCare, AirStrip partner on patient monitoring, cardiac data visualization

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 ...
- Source: drugdu
- 138
- December 6, 2023
NEBGH Helps Employers Combat Cardiovascular Disease in Women Through New Guide

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 ...
- Source: drugdu
- 131
- December 6, 2023
Lilly’s Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing

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 ...
- Source: drugdu
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- December 6, 2023

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