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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
Médecins Sans Frontières is urging Indian generics makers to reject a program Gilead plans to implement in developing countries to prevent illegal diversion of its hepatitis C drugs to more lucrative markets. Read More
An EU-level court has established a precedent that would allow drugmakers to protect orphan drugs from generic competition by developing and patenting a similar drug for the same orphan indications while the original therapy still enjoys market exclusivity. Read More
Biologics makers should file their lot distribution reports using the same electronic messaging standard as is used for drug registration and labeling content of BLAs, FDA final guidance says. Read More