US FDA still deliberating on how best to measure success of the liver safety program for Daiichi's TGCT treatment, but REMS will probably assess both process and outcomes.
The US Food and Drug Administration has yet to determine what would constitute successful risk management for Daiichi Sankyo Co. Ltd.'s proposed rare cancer treatment pexidartinib.
Pexidartinib is proposed for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and...
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.
Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
