One of the uncertainties in the changing of the guard in both the U.S. administration and Congress is the future of 340B reforms. Now the Inflation Reduction Act makes reforms more critical than ever, as it requires manufacturers of drugs selected for price negotiations to certify that they’re giving 340B entities the lowest price, be it the 340B discount or the maximum fair price set by the CMS as part of the negotiation process.

Biopharma financings saw their third highest year, with companies collectively raising $102.15 billion in 2024, behind only 2020 and 2021. The amount marked a 44% jump from $70.97 billion in financings in 2023 and a 68% increase from $60.81 billion in 2022. The fourth quarter (Q4) contributed $15.45 billion, the lowest quarter of the year, following $16.38 billion in Q3, $23.07 billion in Q2, and a strong $47.25 billion in Q1.

At his confirmation hearing, Robert F. Kennedy Jr., the nominee for secretary of the U.S. Department of Health and Human Services, claimed that he is not anti-vaccine. But his record does not bear that out. Kennedy is a longstanding vaccine denier, and in 2021 was identified as one of the “Disinformation Dozen” – the 12 accounts responsible for the majority of disinformation about COVID-19 vaccines on social media platforms – by the British-American nonprofit Center for Countering Digital Hate.

In December 2024 BioWorld recorded 212 clinical trial updates, an increase from 180 in November and closely aligning with 219 in October. The month saw 16 successful phase III outcomes, along with two mixed results and two trial failures. Eli Lilly and Co. reported that its FDA-approved weight-loss drug Zepbound (tirzepatide) outperformed Novo Nordisk A/S’s Wegovy (semaglutide) in the phase IIIb Surmount-5 trial.

The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in December, bringing the year's total to 49.

With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.