FirstWord Pharma

FDA needs more time to review Bayer's hot flash drug $BAYN $ALPMY firstwordpharma.com/story/5984038

BMS shuffles R&D leadership, bringing in AstraZeneca exec as new CMO $BMY $AZN firstwordpharma.com/story/5983918

EU panel deals another blow to DMD gene therapy Elevidys $RHHBY $SRPT firstwordpharma.com/story/5983866

EU hands Blenrep its latest approval, even as US path hits speed bump $GSK firstwordpharma.com/story/5983727

Rocket axes 30% of staff, narrows focus on heart gene therapies $RCKT firstwordpharma.com/story/5983639

Novartis bets on covalent chemistry in $1B Matchpoint deal $NVS firstwordpharma.com/story/5983622

Galapagos mulls sale of cell therapy unit in latest strategic rethink $GLPG firstwordpharma.com/story/5983608

FDA official says Sarepta faces uphill battle to reintroduce DMD therapy Elevidys $SRPT firstwordpharma.com/story/5983501

Roche considering direct-to-patient sales in US to bypass intermediaries $RHHBY firstwordpharma.com/story/5983488

FDA pushes back verdict on GSK's Blenrep by three months $GSK firstwordpharma.com/story/5983382

EU clears J&J's Darzalex as first therapy for smouldering multiple myeloma $JNJ firstwordpharma.com/story/5983164

Roche nabs EU approval of PI3K inhibitor Itovebi for breast cancer $RHHBY firstwordpharma.com/story/5983114

Apnimed firms up filing plans for oral sleep apnoea drug after second pivotal study win firstwordpharma.com/story/5983155

Abivax flexes dual wins for obefazimod in pivotal ulcerative colitis studies $ABVX firstwordpharma.com/story/5983026

Roche halts some shipments of Sarepta's DMD gene therapy outside US $RHHBY $SRPT firstwordpharma.com/story/5983147

Avalyn pulls in $100M to challenge oral lung fibrosis drugs with inhaled rivals firstwordpharma.com/story/5982858

FDA rebuffs accelerated approval of Replimune's oncolytic virus, citing lack of supporting data $REPL firstwordpharma.com/story/5982796

Sanofi to buy respiratory vaccine biotech Vicebio for $1.6B $SNY firstwordpharma.com/story/5982751

Sarepta capitulates on Elevidys pause after FDA pressure $SRPT firstwordpharma.com/story/5982730

AstraZeneca latest pharma giant to commit billions to US operations $AZN firstwordpharma.com/story/5982723