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Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More
Horizon Pharma CEO Timothy Walbert says the company will re-evaluate its relationship with Express Scripts after the pharmacy benefits manager filed suit against the drugmaker and terminated one of its drug dispensers, Linden Care. Read More
FDA AdComm to Review Merck’s Coronary Heart Disease Drugs
Senate Passes VA Appropriations Bill Providing for HCV Treatments
Destiny Pharma Wins QIDP Designation for Staph Drug Read More
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