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The FDA’s Aug. 23 Emergency Use Authorization (EUA) for convalescent plasma to treat COVID-19 has left hospitals with a choice — give the treatment to individual patients under the EUA or enroll them in clinical trials that will help settle the question of the treatment’s safety and efficacy. Read More
Researchers from Moscow’s Gamaleya Research Institute have posted results from two phase 1/2 trials of their controversial COVID-19 vaccine, showing it was safe and induced the production of antibodies in all adult volunteers. Read More
The U.S. may be gearing up for vaccine distribution, but a World Health Organization (WHO) spokesperson said Friday that the international agency doesn’t expect to see widespread vaccination with a COVID-19 vaccine until the middle of next year, stressing that more time is needed for late-stage clinical trials. Read More
China’s National Medical Products Administration has approved Innovent Biologics’ Humira biosimilar Sulinno (adalimumab injection) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis. 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