Following a patient’s death in Poseida Therapeutics Inc.’s phase I trial of P-PSMA-101 in metastatic castrate-resistant prostate cancer (mCRPC), the FDA has put the study on clinical hold.
Sanofi SA is acquiring Principia Biopharma Inc. in a $3.68 billion deal that brings Sanofi three clinical-stage BTK inhibitors and simplifies a partnership that began three years ago. Paris-based Sanofi plans to acquire all outstanding Principia common stock shares for $100 each at a $3.36 billion enterprise value. Sanofi will get SAR-442168 (PRN-2246), the brain-penetrant candidate at the heart of the deal. The agreement now gives Sanofi full control of the program, bringing a three-year partnership between the two companies to an end
The U.S. government bought 100 million doses of mRNA-1273 from Moderna Inc., of Cambridge, Mass., with a new award worth up to $1.525 billion, a deal that drops the implied cost per dose below that of several other companies receiving funding through the government program.
An interim analysis from Fulcrum Therapeutics Inc.’s phase II study of losmapimod for treating facioscapulohumeral muscular dystrophy (FSHD) produced data that pleased the CEO and displeased investors.
Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist.
Bayer AG’s Lampit (nifurtimox) to treat Chagas disease in pediatric patients, approved by the FDA on Friday, is an oral, antiprotozoal medication for newborns to patients under 18, who weigh at least 2.5 kg and are diagnosed with Chagas disease caused by Trypanosoma cruzi.