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The Office of Pharmaceutical Quality is in the midst of its third pilot of integrated quality assessments, a team-based review process that will be the central tenet of OPQ’s review of drug applications. Read More
Two British pharmaceutical giants saw positive results in studies of their respective lupus candidates, a rare show of progress for the underfunded condition with few care options and even fewer innovations. Read More
The U.S. Supreme Court has refused to hear patent infringement cases brought by two drugmakers against Apotex, paving the way for the Canadian company to produce a generic version of Benicar. Read More
N.J. Enacts Biosimilars Substitution Law
Federal Court Imposes TRO on Dr. Reddy’s Generic Nexium
Amgen’s ABP501 Biosimilar Meets Primary Endpoint
Astellas to Acquire Ocata Therapeutics for $379 Million Read More
Valeant Pharmaceuticals executives tried to allay nervous investors in a hastily called conference call Nov. 10, following weeks of scandal and falling stock value. However, participants sounded skeptical of the company’s upbeat assessment. Read More
Roche’s Genentech unit and partner Exelixis scored a regulatory win Tuesday, with the FDA approving Cotellic as part of combination treatment for advanced melanoma. Read More
Serious deficiencies for producing sterile drug products have landed the Johnson Memorial Cancer Center an FDA warning letter, which was posted on the agency’s website Tuesday. Read More
CMS issued a letter to four drug companies that produce or sponsor HCV treatments — AbbVie, Gilead, Johnson & Johnson and Merck — seeking answers as to why these drugs are so costly. Read More