ENTITY
Akeso, Summit’s PD-1xVEGF Drug Ivonescimab Shows Strong Progression-Free Survival Benefit in Global Lung Cancer Trial
Akeso; Summit Therapeutics; ivonescimab; PD-1xVEGF; bispecific antibody; non-small cell lung cancer; progression-free survival; Phase 3 trial; overall survival; FDA approval
Recent Advances for Confident Cell Line Transfer
cell line development; cell transfer; clone stability; electroporation; transfection; quality assurance; GMP compliance; cell therapy
Akeso Scores Two Wins in Phase 3 Trials, Tees Up Regulatory Submissions in China
Akeso; Phase 3 trials; gumokimab; manfidokimab; ankylosing spondylitis; atopic dermatitis; regulatory submission; China; autoimmune diseases; clinical trial results
Royalty Pharma Buys $885M Imdelltra Royalty Stake from BeOne
BeOne Medicines; Imdelltra; Amgen; Royalty Pharma; $885 million upfront; lung cancer; royalty deal; DLL3 bispecific; small cell lung cancer; ES-SCLC
Argenx’s Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis
Vyvgart; Argenx; Phase 3; myasthenia gravis; seronegative; ADAPT SERON; AChR-Ab; MuSK+; LRP4+; triple seronegative; FDA label expansion
MannKind to Acquire scPharmaceuticals in Up to $360M Deal
MannKind; scPharmaceuticals; acquisition; Furoscix; cardiorenal medicine; cardiometabolic diseases; FDA-approved infuser; ReadyFlow autoinjector; merger agreement; tender offer
CNS Pharmaceuticals Pursues Public Offering to Fund Phase 2 GBM Trial After Cost Cuts
CNS Pharmaceuticals; biotech; layoffs; IPO; public offering; phase 2 trial; glioblastoma multiforme; funding; cash position
Argenx Prepares FDA Filing to Expand Vyvgart Use in Myasthenia Gravis After Late-Stage Trial Win
Argenx; Vyvgart; FDA approval; myasthenia gravis; prefilled syringe; self-injection; chronic inflammatory demyelinating polyneuropathy; generalized myasthenia gravis; clinical trial
FDA Begins Daily Publication of Drug Adverse Event Data
FDA; FAERS; adverse event reporting; daily publishing; data modernization; drug safety; real-time monitoring; public health
FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns
FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths