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Indian generics maker Sun Pharmaceutical said that it will close its Detroit, Mich., plant this summer as part of its consolidation of U.S. manufacturing operations. Read More
A federal appeals court has ruled that generic manufacturers of Merck’s osteoporosis drug Fosamax cannot be held liable for “design defect” claims against the product. Read More
Mylan and Actavis are challenging the FDA’s April 24 decision to grant 180-day marketing exclusivity to Teva for a generic version of the blockbuster arthritis drug Celebrex. Read More
The FDA’s top drug official slammed the current clinical trial system as a major barrier to rapid drug development and urged the drug industry to adopt clinical trial networks as a better way to evaluate new products. Read More
AstraZeneca said the FDA has approved its fish oil-based cardiovascular drug Epanova (omega-3-carboxylic acids) for the treatment of adults with very high triglyceride levels. Read More
A federal appeals court has ruled that generic manufacturers of Merck’s osteoporosis drug Fosamax cannot be held liable for “design defect” claims against the product. Read More
A judge in London’s high court has ruled that local healthcare provider organizations known as Clinical Commissioning Groups (CCGs) cannot choose to ignore UK health guidance simply because they disagree with it. Read More
The FDA is seeking industry feedback on a proposed study to better understand direct-to-consumer advertisements that compare drug pricing, and how that information affects a consumer’s perception of a drug’s overall safety and efficacy versus the comparator product. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More