Citeline, a Norstella company

The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

Roche paused shipments of the Duchenne muscular dystrophy gene therapy in countries that reference US FDA approval of Elevidys after the agency asked Sarepta to pause US shipments; it remains available in Japan and Brazil.

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

Scrip spoke with executives at artificial intelligence biotech firms and a big pharma company during the recent BIO conference about using AI in ways that add real value to drug development.

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Biopharma executives and investors at the BIO convention noted the competition emerging from China with high-quality assets that could make strong additions to their portfolios.