Regulatory
Exelixis’ Cabometyx, in combination with two BMS-owned drugs, hit the primary endpoint of progression-free survival but missed the secondary endpoint of overall survival in renal cell carcinoma.
Vertex Pharmaceuticals plans to acquire ViaCyte for $320 million in cash. ViaCyte focuses on stem cell-derived cell replacement therapies that they hope will cure type 1 diabetes (T1D).
HRA Pharma, a Perrigo company, has submitted an application to the FDA seeking approval for the country’s first-ever over-the-counter (OTC) birth control pill.
Sanofi announced positive data for its therapeutic, fitusiran, for treating patients with hemophilia A and B, as well as efanesoctocog alfa therapy for treating hemophilia A.
Last year, the FDA’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.
Adverum Biotechnologies is cutting 78 jobs after announcing it had successfully amended its Investigational New Drug application for ADVM-022.to treat wet age-related macular degeneration.
DiaMedica Therapeutics’ Phase II/III ReMEDy2 trial is on hold by the FDA because patients were experiencing severe drops in blood pressure.
Intercept Pharmaceuticals, Annovis Bio and Biohaven Pharma are moving forward with late-stage Phase III clinical trials.
As the global life sciences industry slows down, companies are gathering money through means other than VC funding. BioSpace shines a light on some of these recent transactions.
Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.
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