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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
AstraZeneca and Eli Lilly have agreed to conduct a clinical trial to assess the safety and preliminary efficacy of AZ’s experimental anti-PD-L1 immune checkpoint inhibitor MEDI4736 in combination with Lilly’s Cyramza treatment for patients with advanced solid cancer tumors. Read More
Canadian drugmaker Tekmira has halted recruitment of patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More
The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More
The FDA has published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More