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...
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
