We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Baxter International has filed a lawsuit against generics maker Mylan over its patent challenge to the brandmaker’s heart rate control drug Brevibloc. Read More
Endo and Bayer are suing generics maker Perrigo’s subsidiary Paddock Laboratories over its patent challenge to the brand firms’ testosterone replacement therapy Aveed. Read More
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
Amgen pulled the plug on its experimental stomach cancer drug rilotumumab after data from two late-stage clinical trials raised serious safety concerns, marking the company’s second failed cancer drug this month. 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The European Medicines Agency wants to improve the access to its unpublished documents, but still reserves the right to refuse a request if disclosure would undermine protected information such as the purpose of an investigation or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
In observance of the Thanksgiving holiday, Drug Industry Daily will not be published Thursday, Nov. 27, or Friday, Nov. 28. The next issue will be published Monday, Dec. 1. Read More