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The Oregon Attorney General has filed a lawsuit accusing four pharmaceutical companies of filing sham lawsuits to prevent competitors from bringing a lower-priced generic version of their drug to market. Read More
In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28. Read More
The FDA has asked GSK to restrict its second-line maintenance indication for its ovarian cancer drug Zejula (niraparib) to patients with deleterious or suspected deleterious germline BRCA mutations, maintaining approval for the drug’s first-line indication. Read More
The Federal Trade Commission (FTC) has filed an amicus brief in the U.S. District Court for the District of Delaware arguing that some branded drug manufacturers have a history of using restricted distribution programs to delay the introduction of generic drugs. Read More
The FDA is seeking public comment on an International Council for Harmonisation (ICH) draft guidance that describes risk-based principles and mitigation strategies to assure viral safety in biotechnology products from cell lines.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