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With drugmakers facing a Jan. 1 deadline to begin complying with new product track-and-trace requirements, the FDA has announced a wide range of options that companies can choose from to satisfy the new law in a short guidance that contains no surprises for industry. Read More
Teva has become the second generics maker to settle a lawsuit alleging that it conspired with AstraZeneca to delay generic entry of its blockbuster heartburn therapy Nexium, a move that comes as the judge overseeing the case continues to dampen plaintiffs’ antitrust claims. Read More
The European Medicines Agency has approved AstraZeneca’s Duaklir Genuair as a maintenance treatment for patients with chronic obstructive pulmonary disease. Read More
Manufacturers that adapt existing drugs and biologics to treat rare diseases could receive an additional six months of market exclusivity for the original indication under a new bipartisan House bill. Read More
The European Commission has approved Eli Lilly’s self-injectable diabetes drug Trulicity, a move that follows the FDA’s approval in September. Read More
India’s drug pricing authority has proposed adding 12 cancer drugs to its list of essential therapies that are subject to price controls, while removing three under-utilized drugs. Read More
The European Medicines Agency wants to improve the access to its unpublished documents, but still reserves the right to refuse a request if disclosure would undermine protected information such as the purpose of an investigation or audit into a company. Read More
By the end of next year the FDA is expected to release rules on drug shortages, biologic safety testing, compounding pharmacy oversight and OTC monographs on cough and cold medicines. Read More
Merck has gained exclusive licensing rights to an experimental Ebola vaccine that is still undergoing clinical trials under a deal with NewLink Genetics. Read More