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The Trump administration’s Aug. 24 deadline has come and gone for the pharma industry to come up with a drug pricing strategy that would prevent a threatened executive order by President Trump from going into effect — but the White House and big pharma have remained silent. Read More
FDA Commissioner Stephen Hahn issued an apology Tuesday for the way he portrayed the effectiveness of convalescent plasma as a COVID-19 treatment during the announcement of the FDA’s Emergency Use Authorization (EUA) — but he stressed the independence of the agency in its regulatory decisions amidst concerns of political pressure. Read More
The FDA rapped an AbbVie manufacturing facility in Barceloneta, Puerto Rico, for good manufacturing practice failures, including missing written procedures. Read More
The FDA has turned down Tricida’s new drug application for veverimer (TRC101) as a treatment for metabolic acidosis in patients with chronic kidney disease and said it needs to see more supporting data. Read More
Moderna announced that it has concluded exploratory talks with the European Commission for a deal to supply up to 160 million doses of its COVID-19 vaccine. Read More
The World Health Organization (WHO) has expressed doubts about the FDA’s decision to grant an Emergency Use Authorization (EUA) for convalescent plasma as a COVID-19 treatment, claiming that the supporting evidence is weak. Read More
AstraZeneca has denied claims that it is in talks with the U.S. government about receiving a potential Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate. Read More