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The FDA is seeking public comment on an International Council for Harmonisation (ICH) draft guidance that describes risk-based principles and mitigation strategies to assure viral safety in biotechnology products from cell lines.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
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
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
Members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee agreed 16-1 that the first-ever inhaled combination of two already-approved asthma drugs would benefit adults, but they declined to recommend it for teens (9-8) and children age four to 12 (16-1). Read More
The FDA’s efforts to improve premarket safety analytics and documentation were met with comments from several drugmakers expressing concerns about standardization and harmonization with other data systems. Read More
Generic drug makers are responsible for providing sufficient information in their abbreviated new drug applications (ANDA) to show that the generic drug’s active ingredient is the same as that of its reference listed drug (RLD), the FDA said in a draft guidance issued today. Read More
In the ongoing saga of the Pasteur Act — a thus-far unsuccessful bill introduced in 2020 to encourage new treatments for fighting drug-resistant pathogens — a group of academics and advocacy organizations sent a letter to Congress contending that the “fatally flawed” bill would squander taxpayer dollars and may exacerbate the threat of antibiotic resistance in the U.S. rather than fix it. Read More
In the latest twist in an ongoing patent case with far-reaching implications, the U.S. Supreme Court will consider Amgen’s petition seeking review of an appeals court decision that invalidated the company’s patent for its blockbuster cholesterol drug Repatha (evolocumab). Read More
Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the rare disease, the scope of the application, the drug’s active substance and mode of action and supporting clinical and nonclinical data. Read More