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Generics maker Glenmark might have infringed on Merck’s Indian patent covering type II diabetes drugs Januvia and Janumet, the Delhi High Court in India said recently in an interim ruling. Read More
European regulators are establishing a task force that will advise on planning, developing, implementing and maintaining international standards on drug product identification. Read More
Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
Drugmakers may use pharmacokinetic bioequivalence studies to compare how two orally-inhaled drugs with the same active substance disperse in the lungs, the European Medicines Agency says. Read More
A federal appeals court has affirmed a lower court ruling that Allergan’s Zymar eye drop patent is invalid because the process is obvious for others to try. The decision paves the way for generic versions of the drug. Read More
The FTC signed off on a divestiture order allowing Sun Pharma’s imminent $4 billion purchase of fellow Indian generics maker Ranbaxy to go forward as long as the companies relinquish rights to the antibiotic minocycline. Read More