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ADARx Pharmaceuticals CEO Zhen Li found her way to biopharma through Merck, where she was inspired by the application of powerful science to human medicine.
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The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.
Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir.
Here’s how companies can ensure they’re in compliance with new requirements that go into effect in August.
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4D Molecular Therapeutics today announced that the Company will present the initial interim 24-week landmark analysis from the Population Extension cohort of the PRISM Phase 2 Clinical Trial evaluating 4D-150 in a broad wet AMD patient population at the ASRS Annual Scientific Meeting being held in Stockholm, Sweden from July 17-20, 2024.
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Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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In the second biggest acquisition of the year, Merck gains the commercial COPD drug Ohtuvayre, which could help offset the loss of revenue when Keytruda’s patent expires later this decade.
The high court’s order blocks a May decision by a California court that temporarily blocked the efforts of Health Secretary Robert F. Kennedy Jr. to drastically reduce the size of his agency’s workforce.
Leerink Partners called the announcement a ‘positive’ given the delayed timeframe and the uncertainty that the administration will implement tariffs at all.
The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of the monoclonal antibody drug class that has led to several deaths.
H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health Secretary Robert F. Kennedy Jr. and a plea from patients with ALS for access to BrainStorm’s NurOwn.
Actithera’s radiopharma assets irreversibly bind to their targets, allowing for longer retention of the drug inside tumors.
Armed with the latest biological knowledge and cutting-edge computational techniques—and, of course, investor dollars—these six biotechs are playing in the largely underappreciated longevity space, developing therapies that may improve the quality of aging.
The industry sector focused on aging is only about 10 years old, but acting on what scientists already know, a new crop of biotechs, backed by investors, are taking a disease-centric approach to extending the human lifespan.
Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.
BrainStorm Cell Therapeutics issued a statement Tuesday supporting a Citizens’ Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose BLA was withdrawn in 2023. A Phase IIIb trial was scheduled to begin last month.