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The Association for Accessible Medicines (AAM) has filed an amicus brief in a federal court in support of Hikma Pharmaceuticals’ generic version of the Amarin Pharmaceuticals heart drug Vascepa. Read More
Within its commitment letter for the upcoming reauthorization of the Prescription Drug User Fee Amendments (PDUFA), the FDA and the pharmaceutical industry have agreed to collaborate closely on pilot programs for rare diseases. Read More
Distributors McKesson, Cardinal Health and AmerisourceBergen and drugmaker Johnson & Johnson (J&J) have until Sept. 4 to decide whether enough states signed on to the proposed $26 billion opioid settlement by the Aug. 21 deadline to allow the deal to go forward. Read More
The drug sponsor “would require specialist expertise in AI, data quality and pharmacovigilance signal detection to govern its use,” the ICMRA says. Read More
Generic drug sponsors should use the highest strength of the drug in their pivotal bioequivalence studies, unless safety considerations forbid that, the FDA recommends in a new guidance. Read More
Insulin makers Eli Lilly, Novo Nordisk and Sanofi are under even more pressure from Congress to justify high and rising prices for their product. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is setting up a new board to strengthen pharmaceutical supply-chain monitoring in the wake of COVID-19-related drug shortages, CDER Director Patrizia Cavazzoni announced on Friday. Read More
Federal officials are said to be examining whether Moderna’s COVID-19 vaccine is linked with higher risks of heart inflammation in younger people than once thought, possibly delaying the shot receiving authorization for adolescents. Read More
The White House said Friday that acting FDA Commissioner Janet Woodcock has not been taken off the list of potential nominees to head the agency despite widespread media reports. Read More
Manufacturers are “already assessing whether they are affected by these vulnerabilities, evaluating the risk and developing remediation actions,” the agency said. Read More