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The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain could be a reasonable predictor of clinical benefit.
Sanofi’s asthma drug Dupixent met all targets in a trial to treat “smoker’s lung”, potentially adding billions to the French drugmaker’s growth prospects, but also underscoring a heavy reliance on its bestseller.
The deal gives Moderna access to Generation Bio’s proprietary drug delivery system and DNA technology to develop drugs targeting immune cells and the liver.
Antibiotics maker Melinta Therapeutics, which has commercialization rights for the drug in the U.S. market, plans to make rezafungin available this summer.
The agency approved the therapy in Merkel cell carcinoma patients for whom the cancer has come back or spread to other parts of the body.
Flare Therapeutics closed Wednesday an oversubscribed Series B funding round, counting $123 million in earnings, which it will use to advance its lead precision oncology asset FX-909 in urothelial cancer.
Abbvie said it plans to resubmit the marketing application as soon as possible.
Altimmune released mid-stage data Tuesday showing pemvidutide helped reduce patients’ weight by 10%, but the company’s shares tumbled 55% over safety concerns with the obesity drug.
The expanded approval makes Regeneron’s Evkeeza the first drug to treat kids under 10 with the condition.
Under the ORION-17 trial, planned to involve 40,000 patients, Novartis was trying to show that its Leqvio drug could prevent the first occurrence of major cardiovascular health problems in high-cholesterol patients, part of a broader collaboration with the British health system.
