Kevin J. Tracey and Christina Brennan | Dec 1, 2020 | 4 min read
As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.
Although scientists debate the ethics of deliberately infecting volunteers with SARS-CoV-2, plenty of consenting participants have been exposed to all sorts of pathogens in prior trials.
The physician-researcher laid the groundwork for genetic cloning and led the US Food and Drug Administration as the country faced the AIDS crisis in the 1980s.
The agency cites safety concerns with customers of Genetech who reported getting E. coli infections and sends letters to other stem cell companies reminding them to follow the rules.
Among a subset of US Food and Drug Administration regulators who leave the agency, more than half go to work for pharmaceutical companies, researchers report.
The change should allow patients with fatal illnesses easier access to experimental drugs, but gaining permission from drug companies remains the biggest challenge.
A panel of experts advised the US Food and Drug Administration that BioMarin Pharmaceutical has not demonstrated efficacy of its new drug for Duchenne muscular dystrophy.
In the midst of a debate about an experimental drug’s early approval, the US Food and Drug Administration requests that full trial results be released.
Biotech company Genervon has requested accelerated approval for its experimental ALS drug after a small but promising Phase 2 trial. Patients advocate for its acceptance, while researchers urge caution.
More than a third of US drug approvals are based on a single large clinical trial, while others require more in-depth study, according to a new report.