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The FDA is seeking public comment on an International Council for Harmonisation (ICH) draft guidance that describes risk-based principles and mitigation strategies to assure viral safety in biotechnology products from cell lines. Read More
EQRx Therapeutics is dropping its U.S. developmental efforts for sugemalimab plus chemotherapy, a combination it was working on as a treatment for stage IV nonsmall cell lung cancer (NSCLC). Read More
BrainStorm Cell Therapeutics received an FDA refusal to file letter for NurOwn — the FDA’s third negative reaction to the investigational treatment — an autologous stem cell therapy aimed at promoting new nerve growth in patients with amyotrophic lateral sclerosis (ALS). Read More
The FDA offers detailed information on the regulatory flexibilities it offers to drugmakers that have products in expedited programs to help them overcome chemistry, manufacturing and controls (CMC) in a Manual of Policies and Procedures (MAPP) released yesterday. Read More
Because Abraxis Bioscience, a subsidiary of BMS, didn’t fix the problem of multiple media fill failures along the aseptic processing line at its biologics plant, the FDA hit the Phoenix, Ariz., company with a warning letter. Read More
Addressing sponsors’ desires to evaluate multiple versions of cell and gene therapy candidates in a single early phase trial, the FDA has issued guidance that encourages separate Investigational Drug Applications (INDs) but under an umbrella trial design. Read More
ADC Therapeutics’ Cami (camidanlumab tesirine), an investigational antibody-drug conjugate, has hit the end of its quest to gain accelerated approval for adults with heavily pretreated Hodgkin lymphoma, but — if ADC can find a willing partner — it may live on as a combination treatment for solid tumors. Read More
In an 8-5 split, the members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted yesterday against an emergency use authorization (EUA) for VERU-11 (sabizabulin) for treatment of COVID-19 at patients at high risk for acute respiratory syndrome which occurs when fluid builds up in the lungs. Read More