FDA gives nod to Moderna vaccine for Covid-19
The company's vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.
With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race
The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
FDA issues Covid-19 vaccine guidance as White House reportedly relents
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, which pushes the date of an EUA past Election Day.
Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study
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.
Inovio shares sink after FDA places partial hold on Phase II/III Covid-19 vaccine study
The company emphasized that the partial hold was due to "additional questions" about the study, including the delivery device being used, and was not related to any adverse events. As such, the Phase I study of the vaccine, INO-4800, is proceeding.
La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
The New York Times reported that in a memo, Alex Azar stated that the power to sign new rules is "reserved" for him, a move that one expert called a "power grab." It is unclear how it will affect authorizations of vaccines against the coronavirus.
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A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
NIH panel contradicts FDA on authorization for convalescent plasma in Covid-19
The agency's Covid-19 Treatment Guidelines Panel stated there was insufficient evidence for or against the treatment and pointed out that in certain groups, such as intubated patients, no benefit in seven-day overall survival was observed.
FDA’s Hahn draws renewed criticism over apparent willingness to fast-track Covid-19 vaccine
In an interview with The Financial Times Sunday, the embattled FDA commissioner said he would be open to the agency green-lighting a vaccine against the SARS-CoV-2 virus before Phase III trials are complete. The agency also ousted its spokesperson, Emily Miller, after only 11 days on the job Saturday.
Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend
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 staffers, prompting calls for his resignation.
FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy
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 and data alone - may have played a role.
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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.
Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns
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.
FDA rejects BioMarin’s hemophilia A gene therapy in ‘massive surprise’
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 issue.
FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug
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.
FDA approves Roche drug for rare autoimmune disorder NMOSD
The agency approved Enspryng for the disease, which is often misdiagnosed as multiple sclerosis and can cause blindness, muscle weakness and paralysis.