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In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The designation, granted last month, was the first of its kind to be announced publicly.
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It’s early days for xenotransplantation, but eGenesis, Eledon, United Therapeutics and more are working to develop solutions to make this approach a viable option and help ease the organ shortage crisis.
Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue.
Since 2016, the FDA has approved three disease-modifying treatments for spinal muscular atrophy, with several companies—including Novartis, Scholar Rock and Biogen—progressing novel candidates through clinical trials.
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Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab’s efficacy and safety profile before making its final decision on whether to grant the drug approval.
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After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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Looking for a new opportunity in New Jersey? These nine companies have open roles that could be a great fit for you.
The eight new committee members replace the 17 Kennedy removed earlier this week. In “repopulating” the committee, the HHS Secretary fulfilled the fears of some analysts, naming scientists who appear to reflect his anti-vaccine views.
The downsizing comes after a year of workforce cuts and reorganization for Roche’s subsidiary.
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s priorities, including accelerating cures and the rapid deployment of artificial intelligence.
Instead of homing in on PSMA—currently the most validated target in prostate cancer—BMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3.
The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration.
The American Medical Association is also urging an “immediate reversal” of the HHS Secretary’s decision to oust all 17 members of the CDC’s vaccine advisory board.
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one.
Guggenheim Partners called Insmed’s Phase IIb readout “impressive across the board,” with an efficacy profile that positions TPIP to be best-in-class in pulmonary arterial hypertension.
For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharma’s amylin efforts underwhelmed investors.