Food and Drug Administration (FDA)
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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).
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.
DiaMedica Therapeutics’ Phase II/III ReMEDy2 trial is on hold by the FDA because patients were experiencing severe drops in blood pressure.
When GSK’s consumer health spinoff Haleon launches later this month, the new business will carry more than $12 billion in debt when it lists on the London Stock Exchange.
Intercept Pharmaceuticals, Annovis Bio and Biohaven Pharma are moving forward with late-stage Phase III clinical trials.
The granting of the EUA comes with certain limitations, as the prescribing pharmacist must refer patients for clinical assessment with a physician.
Emory University’s Ken Thorpe told BioSpace that the average Medicaid spending on drugs approved under the accelerated pathway in relation to total Medicaid spending is.2%.
A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.
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