The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
Penn spinout, Verismo Therapeutics, says the FDA has granted Orphan Drug Designation (ODD) to its KIR-CAR T-cell immunotherapy drug, SynKIR-110, for the treatment of patients with mesothelin-expressing mesotheliomas.
iBio is jockeying for position as a leading player in AI-powered drug discovery while also expanding its immuno-oncology pipeline after closing on the acquisition of multiple assets from its partner, RubrYc Therapeutics.
The US National Institutes of Health plans to invest $130m in accelerating the widespread use of artificial intelligence (AI) by the biomedical and behavioral research communities through its Bridge2AI program.
Rocket Pharmaceuticals, a late-stage, clinical biotech advancing a pipeline of genetic therapies for rare childhood disorders, will acquire Renovacor: helping it strengthen its position in AAV-based cardiac gene therapy.
A new pilot training model, one using augmented reality (AR) and virtual reality (VR) to support learning, is aimed at individuals looking to boost their knowledge and skills so they can continue to progress the area of Advanced Therapy Medicinal Product...
Ncardia’s cell therapy development and manufacturing business Cellistic will acquire Celyad Oncology’s GMP grade cell therapy manufacturing capability, covering Celyad’s Mont-Saint-Guibert facility in Belgium and all related staff.
The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bio’s Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral...
Pfizer will submit a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine (MenABCWY) to the US Food and Drug Administration (FDA) later this year, following positive top-line results from a Phase 3 trial.
Novo Nordisk and Microsoft have entered a new strategic collaboration to combine Microsoft’s computational services, cloud, and artificial intelligence (AI) with Novo Nordisk’s drug discovery, development, and data science capabilities.
Orca Bio, a biotech developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, will expand its current manufacturing capabilities with the construction of a new 100,000-square-foot commercial...
What role does Bioprocessing 4.0 have to play in the ongoing energy crisis? How can we train and develop the right skills for the industry? These are just some of the questions we’ll ask in our free-to-attend webinar tomorrow!
A collaboration between Touchlight and Lonza expands the Swiss CDMO’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material, the UK biotech’s doggybone DNA (dbDNA).
Technology firm, Benchling, has developed what it calls the biopharma industry’s first set of full capabilities for designing, modelling, and studying both natural and chemically modified RNA in a single platform.