USA – FDA officials: ‘Significant work’ still needed for rare disease drug development
While much progress has been made in approving treatments for rare diseases, more work is needed in this area, asserted Kerry Jo Lee, MD,...
Europe – EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2...
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement on adapted COVID-19 vaccines and considerations...
Switzerland – New COVID-19 vaccine successfully tested
Rocketvax and researchers at the University of Basel have linked up to develop a new approach for a COVID-19 vaccine.
Researchers led by Professor Thomas...
USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals...
USA – Accelerated approval trials: Commenters seek details on single-arm considerations
The US Food and Drug Administration (FDA) aimed to address some of the criticisms of its accelerated approval program with new draft guidance that...
USA – FDA finalizes drug-drug interaction guidance for therapeutic proteins
The US Food and Drug Administration (FDA) on Friday issued a final guidance to assist sponsors in determining whether to conduct drug-drug interaction studies...
USA – FDA issues draft guidance on developing migraine prevention drugs
The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations...
USA – FDA considers new efficacy endpoint for diabetes drugs
The US Food and Drug Administration (FDA) on Friday released an updated draft guidance to help sponsors demonstrate efficacy for new antidiabetic drugs and...
UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...
USA – FDA finalizes guidance on adjusting for covariates in randomized trials
The US Food and Drug Administration (FDA) on Friday released a final guidance addressing how sponsors can adjust for covariates in analyzing randomized clinical...
