The drug and device industries have a lot hinging on the results of the Nov. 5 U.S. presidential and congressional elections. Tax policies. The reach of the FTC. Legislation aimed at drug prices, competition, pharmacy benefit managers and lab-developed tests. Cabinet and agency appointments that could reshape Medicare drug negotiations, the 340B program, FDA Orange Book device patent listings, regulatory flexibility and Bayh-Dole march-ins. And that’s just the top of the list.

The BioWorld Cancer Index (BCI) took a hit in September, ending the month down 11.52%, a notable slide from its 3.94% decline at the end of July and 9.63% drop by the end of August. The BCI’s performance starkly contrasts with the Nasdaq Biotechnology Index, which jumped 9.09%, and the Dow Jones Industrial Average’s 12.31% gain over the same nine-month period. This marks a stark reversal for the BCI, which had a standout year in 2023, closing with a 76.26% gain.

In September 2024, BioWorld recorded 252 clinical trial updates, up from 92 in August, due in part to news from the European Society for Cardiology Congress, the IASCLC World Conference on Lung Cancer and the European Association for the Study of Diabetes, among others. The month included 35 successful phase III trial updates and four failures.

In September 2024, BioWorld recorded 252 clinical trial updates, up from 92 in August, due in part to news from the European Society for Cardiology Congress, the IASCLC World Conference on Lung Cancer and the European Association for the Study of Diabetes, among others. The month included 35 successful phase III trial updates and four failures.

If the maximum fair prices the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition.

The approval of Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) hypoparathyroidism – the first and only treatment for adults with the rare endocrine disease – did little to sate the market’s appetite for new drugs in the indication, where a number of players are busy in various stages of development.