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The FDA has posted suggestions for ways to filter out viral contamination during continuous manufacturing of therapeutic proteins, based on studies conducted within the Center for Drug Evaluation and Research. Read More
Johnson & Johnson (J&J) has announced that it will submit data to the FDA showing that its booster shot dramatically raises the levels of antibodies against COVID-19 in people vaccinated six months prior. Read More
More than one-third of consumers and a quarter of physicians exposed to websites with five deceptive claims and tactics “indicated that no inaccuracies were present,” the OPDP found. Read More
In addition, the European regulator has approved a new finished product manufacturing site for the Moderna vaccine in Indiana, owned by Catalent. Read More
Purdue Pharma has released an updated bankruptcy plan that more narrowly defines the legal protections members of the Sackler family would receive in a settlement in a significant shift aimed at addressing the concerns of the federal judge presiding over the company’s bankruptcy case. Read More
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