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Replimune is axing 144 employees at its Woburn headquarters and 80 at its Framingham manufacturing site. The cuts follow the FDA’s second rejection of the biotech’s advanced melanoma candidate.
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Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
The Merck update, which will shed light on a $588 million bet to succeed Keytruda, is part of a roster of presentations that could shape the future of ADCs, protein degraders and KRAS-targeted therapies.
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Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
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Nuclidium’s radiopharmaceutical platform is unique in its use of copper-based payloads, which the biotech claims can deliver higher doses while also being safer.
The deal gives AstraZeneca’s rare disease unit Alexion access to specialized capsids developed by the Japanese biotech JCR Pharmaceuticals for use in up to five of Alexion’s gene therapies.
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.
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.