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AstraZeneca eyes first-line gMG market with self-administered gefurulimab
Biotechnology
UK pharma major AstraZeneca is preparing to advance gefurulimab as a potential new treatment for generalized myasthenia gravis, following positive results in a global Phase III trial that could pave the way for regulatory filings.   24 July 2025


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Biotechnology
US biotech Genascence today announced the US Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to GNSC-001, a potential first-in-class gene therapy blocking interleukin 1 (IL-1) for the treatment of knee osteoarthritis (OA).   16 July 2025

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Last week, a US Food and Drug Administration (FDA) advisory committee (AdCom) voted against approval of Danish drugmaker Lundbeck and Japan-based Otsuka’s Rexulti for post-traumatic stress disorder. France’s Sanofi announced it is expanding its respiratory vaccines pipeline with an up to $1.6 billion acquisition of UK biotech Vicebio. French biotech Abivax released new Phase III data on its investigational ulcerative colitis candidate obefazimod that saw its shares nearly quadruple. Also of note was the latest setback for Sarepta’s Duchenne muscular dystrophy drug Elevidys, when the European Medicines human health committee, the CHMP, declined partner Roche’s accelerated approval of the drug.   27 July 2025

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