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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
Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. Read More
Pfizer is suing a Texas health agency for disclosing pricing and rebate information to state lawmakers, alleging the release violates state and federal laws on confidential data. Read More
Outsourcing facilities and states have faulted the FDA for sluggish progress toward finalizing guidance documents on drug compounding and the differences between state and agency inspection protocols, according to the U.S. Government Accountability Office. Read More
Pharmaceutical representatives in Chicago must complete a professional education course and be licensed before conducting business, following the unanimous passage of a new ordinance by the city council as part of its plan to combat the opioid epidemic. Read More