Sanofi US
NEWS
Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir.
The Plavix lawsuit dates back to 2014, when Hawaii first sued BMS and Sanofi, alleging that they failed to properly inform patients in the state that the drug is likely to be less effective for them.
After losing its powerhouse partner, IGM Biosciences closed “most” of its labs and offices and initiated a strategic review of potential strategic alternatives and options for the business.
On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
Analysts at Leerink agreed with Sanofi that, despite falling short of statistical significance in the Phase II TIDE-Asthma trial, amlitelimab warrants further development in this indication.
Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.
The deal is the latest in a series of Sanofi investments in its immunology portfolio. According to Sanfoi, DR-0201 can achieve deep B cell depletion, giving it the potential to reset the immune system.
On the agenda for the FDA this month are two RNA-based treatments for rare diseases.
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
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