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An industry group has updated its pharmaceutical supply chain management guideline, implementing the latest changes in data standards ahead of federal standards mandating the ability to track and trace individual drug products. Read More
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More
The FDA has updated final guidance on safety testing for drug metabolites to conform to the ICH’s latest standards on toxicity detection and testing. Read More
The FDA approved two rival therapies for type 2 diabetes on the same day — Sanofi’s Soliqua and Novo Nordisk’s Xultophy — following a long race to produce the next blockbuster drug. Read More
Antera Therapeutics has drawn FDA scrutiny for marketing and selling Aralyte, a kit of capsules filled with liquid peanut protein, as a preventative treatment to keep children from developing peanut allergies. Read More
GlaxoSmithKline has filed an amicus brief in support of Bristol-Myers Squibb’s U.S. Supreme Court petition, which asks for a review of the California high court’s decision allowing plaintiffs outside the state to sue the drugmaker in the state’s court system. Read More
Mylan declined to voluntarily testify before a Senate committee on its settlement with the Justice Department over its misclassification of the EpiPen for a Medicaid drug rebate program. Read More