The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance,… Read More »FDA issues Covid-19 vaccine guidance as White House reportedly relents
Food and Drug Administration
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA… Read More »Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend
While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science… Read More »FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy
Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19
Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.
The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.
In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to rely on the earlier trial to support durability of effect, which an analyst said likely referred to a product comparability… Read More »FDA rejects BioMarin’s hemophilia A gene therapy in ‘massive surprise’
While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
The agency approved Enspryng for the disease, which is often misdiagnosed as multiple sclerosis and can cause blindness, muscle weakness and paralysis.
Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of which are under investigation, the company said.