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Generics manufacturer Amphastar Pharmaceuticals was silenced by a federal judge in California over its latest whistleblower lawsuit in a 12-year battle over Sanofi’s blockbuster anticoagulant Lovenox. Read More
A Johnson & Johnson factory that closed in 2010 after being at the center of massive recalls of over-the-counter products is close to reopening, the company said Tuesday. Read More
The FDA and its European counterpart will establish a joint patient engagement working group to share best practices on involving patients in drug development and monitoring. Read More
The FDA has banned all imports from Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, facility due to current good manufacturing practice violations, making it the latest in a growing list of Indian firms facing agency action. Read More
Reports of adverse drug reactions in China rose by less than 1 percent last year, compared with 2013, with injectables showing the biggest increase, data released by the China Food and Drug Administration shows. Read More
The FDA has given Blueprint Medicines the go-ahead to begin Phase I clinical trials for its investigational BLU-285 and BLU-554 to treat gastrointestinal tract, liver and biliary duct cancers. Read More
The UK’s healthcare costs regulator is recommending Daiichi Sankyo’s oral anticoagulant Lixiana as a cost-effective drug that causes less disruption to patients’ lives while treating blood clots in deep veins that could lead to fatal blockages. Read More
The European Medicines Agency has initiated a review of human papillomavirus vaccines to determine if product information should be updated, following reports of rare but serious conditions that may be associated with their use. Read More
Otsuka and H. Lundbeck expect to launch once-daily Rexulti as a treatment for schizophrenia and add-on therapy for major depressive disorder in early August, following FDA approval Monday. Read More
AstraZeneca’s kinase inhibitor Iressa received FDA approval Monday as the first and only first-line treatment for patients with metastatic non-small cell lung cancer whose tumors have certain types of gene mutations, along with a companion diagnostic. Read More