Regulatory
Aldeyra Therapeutics announced results from a crossover clinical trial, showing that its drug candidate reproxalap was effective in improving ocular redness and tear production in patients with dry eye disease.
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.
PRESS RELEASES