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Multiple drugmakers have reportedly drafted a public pledge not to seek FDA approval of their COVID-19 vaccines until they meet certain safety and efficacy standards even as President Trump said a vaccine may be ready as soon as October. Read More
The FDA has updated its guidance on the use of convalescent plasma to treat COVID-19 or in clinical trials of treatments to take account of the administration’s Aug. 23 Emergency Use Authorization (EUA). Read More
Democrats on the House Energy and Commerce committee urged HHS Secretary Alex Azar yesterday to protect the 340B Drug Pricing Program following threats from several drugmakers to end discounts to hospitals that they pass on to patients under the program. Read More
The FDA has ousted another high-ranking communications officer following fallout from FDA Commissioner Stephen Hahn’s misrepresentation of convalescent plasma as a COVID-19 treatment. Read More
Drugmakers are concerned that President Trump may expedite implementation of an executive order aimed at lowering drug prices by ordering HHS to issue an interim final rule ahead of the Nov. 3 presidential election. Read More
California this week passed a bill that would allow the state to partner with generic drugmakers to manufacture its own generics, making it the first state to try this approach to lowering drug prices. Read More
President Trump announced that he would meet with pharma executives this week to discuss drug pricing and his controversial “favored nations” executive order — but PhRMA claimed it hasn’t heard of any such meeting. Read More
Centers for Disease Control and Prevention Director Robert Redfield has sent a letter to the governors of all 50 states urging them to be prepared for COVID-19 vaccine distribution by Nov. 1 — just two days ahead of the presidential election. Read More
The National Institutes of Health (NIH) on Wednesday said that there’s currently not enough data to say if convalescent plasma should be recommended or rejected as a COVID-19 treatment, doubling down on its previous advice to the FDA to delay Emergency Use Authorization (EUA) until more evidence is available. Read More
The FDA has denied a citizen’s petition from the Southern Network on Adverse Reactions (SONAR) to change the labeling on Johnson & Johnson’s antibiotic Levaquin (levofloxacin). Read More
The FDA released a straight-to-final guidance yesterday on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Read More