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FDA investigators found numerous GMP lapses at Innoveix Pharmaceuticals’ facility in Addison, Texas, including empty syringes, vials, gloves, and other materials left in a biosafety cabinet overnight. Read More
Two lawmakers are pressing Jaguar Health to reverse the three-fold price hike on its diarrhea drug Mytesi (crofelemer) that has been considered as a possible COVID-19 treatment. Read More
Pfizer and BioNTech have started a U.S. trial of COVID-19 vaccine candidates at the NYU Grossman School of Medicine and the University of Maryland School of Medicine. Read More
More than a dozen countries — with the notable exception of the United States — have pledged to contribute approximately $8 billion to develop potential COVID-19 vaccines and treatments. Read More
The former director of HHS’s Biomedical Advanced Research and Development Authority (BARDA) has filed a whistleblower complaint claiming he was removed from his role as head of the federal vaccine development agency in part for pushing for a more aggressive response to COVID-19. Read More
A Federal appeals court has upheld the FDA’s denial of a new drug application for an abuse-deterrent formulation of oxycodone from Pharmaceutical Manufacturing Research Services (PMRS). Read More
Blood pressure medications do not increase the risk of contracting COVID-19 or of serious illness or death in COVID-19 patients as previously thought, three large observational studies showed. Read More
HHS and FEMA will control the distribution of Gilead’s remdesivir as a COVID-19 treatment as a condition of its Emergency Use Authorization (EUA) by the FDA. Read More