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 (PBMs) 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.
Post-earnings, Wall Street weighs Regeneron situation
Shares of Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) have been stressed since the firm reported third-quarter earnings Oct. 31, and investors are debating the importance of recent events. Regeneron’s Eylea (aflibercept) for wet age-related macular degeneration may be threatened by the advent of Amgen Inc.’s recently disclosed plans to launch biosimilar Pavblu as much as a year earlier than expected. At the same time, competitor Avastin (bevacizumab, Roche AG) has had trouble lately with supply disruptions of compounded Avastin which, some argue could favor branded VEGF products in the space. “It’s not the end of the world as we know it, despite [the] stock action,” Piper Sandler analyst Christopher Raymond said in a report. After the earnings update, Regeneron’s sizeable stock sank 12%, from $925 to $819.96, and was trading today at $844.50, up $6.30.
EFPIA calls for EMA to oversee AI in drug development
Just ahead of the EMA setting out its latest thinking on regulation in the new era of artificial intelligence (AI), the industry has put forward its position on how to ensure AI rules enable, rather than hinder, the drug development and approval process. Key issues for pharma are that the EMA’s AI policies do not diverge from other regulators, that the aspects of the drug lifecycle where the use of AI is policed by the EMA are clearly defined, and that the transparency requirements to ensure AI tools are trustworthy do not cut across intellectual property rights or patient privacy.
Steady gains in biopharma deals as grants see sharp year-over-year increase
Through September 2024, biopharma firms secured $720.56 million in nonprofit deals, marking a 21% rise from the $593.23 million in the first three quarters of 2023, though still falling short of 2019-2022 levels. Grants saw an even sharper surge, jumping 131% year-over-year from $1.66 billion to $3.84 billion in the same period, falling short only of 2020 in value.
Essa ends prostate cancer bid, seeks strategic options
Shares of Essa Pharma Inc. tanked Nov. 1 after the company said it is terminating all trials of masofaniten, its N-terminal domain androgen receptor inhibitor and sole clinical-stage program, following a disappointing readout from a phase II study in metastatic castration-resistant prostate cancer. A review of strategic options is up next for the company, which had a cash position of $130.7 million as of June 30, expected, at that time, to be sufficient to carry operations beyond 2025.
Also in the news
Aerovate, Alloy, Alpha Cognition, Anavex, Appili, Atara, Bpgbio, Cardiff Oncology, Compass Pathways, Curevo, Edesa, Eisai, Evommune, Forus, Hutchmed, Jade, Kancera, Kashiv, Libra, Novo Nordisk, NRG, Pharmaessentia, Recce, Roche, Septerna, Tiziana, Ventus, Werewolf