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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
Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for local regulators to tag along on FDA drug manufacturing inspections as observers. Read More