Three host-targeted immune modulators, three anticoagulants, and three to six neutralizing antibodies are to be tested in ACTIV clinical trials, FNIH's David Wholley tells DIA meeting.
The National Institutes of Health's public-private partnership, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), has selected the first therapeutic agents for its COVID-19 master protocol clinical trials.
David Wholley, senior VP of research partnerships at the Foundation for the National Institutes of Health (FNIH), described ACTIV's accomplishments to date at the Drug Information Association's virtual meeting 16 June
In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.
US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
