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Public health advocates called on the FDA Wednesday to expand access to the opioid overdose reversal drug naloxone by converting it from prescription-only to over-the-counter status. Read More
The FDA is revoking general safety test requirements that are duplicative in biologics licensing applications and proposing to remove two obsolete regulations for the review and reclassification of biologics licensed before July 1972. Read More
A federal judge has ordered Apotex to pay AstraZeneca $98.5 million for infringing on patents to the latter’s heartburn drug Prilosec, following an appellate decision affirming most of a $76 million award from a 2013 ruling. Read More
Genentech, whose scleroderma treatment Actemra recently gained breakthrough therapy status from the FDA, topped the list of drugmakers making payments to physicians and teaching hospitals last year, with at least $274.2 million in general payments and $99.2 million in research payments covering more than 16,000 transactions. Read More
Two patient advocacy groups are suing the FDA to force it to release raw clinical trial data on Gilead Sciences’ groundbreaking hepatitis C drugs Sovaldi and Harvoni. Read More
India’s government has announced plans for a $78 million venture capital fund to offer loans to drug companies that are building or expanding manufacturing facilities. Read More
Celgene and Juno Therapeutics have entered into a 10-year collaboration leveraging their T cell strategies to develop treatments for patients with cancer and autoimmune diseases. Read More
Roche announced positive results from two Phase 3 studies pitting its investigational multiple sclerosis drug ocrelizumab against the standard-of-care in patients with relapsing MS, the most common form of the disease. Read More
The European Commission says it does not have the power to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More