Clinical-stage biotechnology company Tenaya Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its gene therapy product candidate, TN-201.
Novartis has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended approval for the company’s Entresto (sacubitril/valsartan) to treat paediatric heart failure.
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Rocket Pharmaceuticals’ RP-A501, an investigational adeno-associated virus (AAV)-based gene therapy to treat Danon Disease.
Biopharmaceutical company Quantum Genomics has signed an exclusive license and production agreement with Julphar to market and manufacture firibastat.
Merck (MSD) has agreed to acquire all the outstanding shares of Acceleron Pharma for $11.5bn in cash.
Cambridge-based global, science-led biopharmaceutical company AstraZeneca and German manufacturer of viral vaccines and biologics IDT Biologika have signed a Letter of Intent (LOI) to increase Europe’s Covid-19 vaccine manufacturing capability.
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