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Nothing is stopping Sandoz from launching the first U.S. biosimilar, now that a federal judge has denied Amgen’s bid for an injunction blocking the alternate version of its blockbuster chemotherapy product Neupogen. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers for serious manufacturing quality violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
Hundreds of children as young as two years old will now be able to get Vertex Pharmaceuticals’ game-changing cystic fibrosis treatment, following FDA approval Thursday. Read More
Janssen’s blockbuster Xarelto is the target of another liability lawsuit, this time by 12 plaintiffs in California federal court who claim the blood thinner caused gastrointestinal bleeding. Read More
Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks. Read More
The Indian government is planning to relaunch a program that would sell hundreds of quality generic drugs at low cost under its own label, Jan Aushadhi. Read More
The drug pricing authority in India published a compilation of the price caps for 509 drugs, effective this past Jan. 31, to give drugmakers a single source of pricing information. Read More
The European Medicines Agency is establishing a task force to implement common standards for identifying medicines across EU member states, and will require industry and regulators to comply with them beginning in July 2016. Read More