Government
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.
In 17 identical letters posted to his Truth Social account, the president said companies must lower their prices or the government ‘will deploy every tool in our arsenal to protect American families from continued drug pricing practices.’
For now, Sanofi’s U.S. inventory is insulating the company from a potential 15% tariff on drugs shipped from the EU.
Employed biopharma professionals are highly likely to look for new jobs in the next 12 months, although not quite as likely as their unemployed counterparts, according to a BioSpace LinkedIn poll. Three recruitment experts discuss the findings and what’s driving job searches.
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a second FDA division to his portfolio after Vinay Prasad’s sudden departure.
Monarez is the first CDC director to be confirmed by the Senate under a new 2023 law and will be the first person without a medical degree to assume leadership of the agency in more than 70 years.
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price negotiation purposes—even if approved by the FDA under a separate application—disincentivizing companies from investing time and money in gaining approval for new formulations and indications.
Six weeks after HHS Secretary RFK Jr. cited unexplained conflicts of interest in dismissing all 17 members of the CDC’s vaccine advisory committee, Democrats are asking for details.
While some analysts forecast the tariffs could mean billions in additional industry expenditure, others expect the overall impact to be “manageable.”
PRESS RELEASES