Even though investors viewed the FDA's willingness to give Sarepta another chance to provide more data as a positive step, most analysts said it was simply delaying the inevitable of rejecting the firm's Duchenne muscular dystrophy drug eteplirsen. Others have cautioned the FDA may be setting a new standard for approving rare disease drugs, in which other companies may demand similar attention.
The FDA has done it again – put off its decision on Sarepta Therapeutics Inc.'s new drug application (NDA) for its Duchenne muscular dystrophy (DMD) drug eteplirsen, this time telling the firm regulators want dystrophin data, as measured by Western blot, from biopsies already obtained from the company's ongoing PROMOVI confirmatory study.
Sarepta said it would submit data to the FDA "in the coming weeks" from biopsy samples from 13 patients who...
The Swiss pharma company is rebalancing the portfolio, emphasizing best-in-class drugs and moving into new areas like cardiovascular and metabolic disease.
In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
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