Finger-pointing abounded Tuesday in a Senate hearing on prescription drugs prices, where branded and generic drug industry representatives testified alongside pharmacist, wholesale distributor and benefit manager groups. Source: Drug Industry…
The European Medicines Agency outlined its thoughts on the use of evidence generated through extrapolation techniques in regulatory assessments, in a draft reflection paper. Source: Drug Industry Daily
A federal judge ruled that Actavis Laboratories infringed on patents held by Orexigen Therapeutics. Source: Drug Industry Daily
A federal judge halted sales by a California company that customizes dietary supplements by name and formulation until the company clears an FDA inspection. Source: Drug Industry Daily
The European Medicines Agency will try to maintain “business as usual” for as long as possible throughout the U.K.’s upcoming exit from the European Union, according to a newly released…
A Texas judge on Monday invalidated the Restasis patents Allergan controversially transferred to a Native American tribe. Source: Drug Industry Daily
The European Medicines Agency’s Committee for Medicinal Products for Human Use had a light meeting load this month, recommending approval for a single generic medicine and expansions of indications for…
A new Cancer Moonshot collaboration of NIH with 11 biopharmaceutical companies will undertake to identify and validate biomarkers to advance immunotherapies as its first order of business, the agency announced.…
The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to…
An FDA advisory committee voted 10-0 in favor of the efficacy of a drug candidate for treatment of glaucoma and ocular hypertension Friday. Source: Drug Industry Daily