With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with EGFR exon 20 insertion mutations who previously received platinum-based chemotherapy. The FDA granted zipalertinib breakthrough therapy designation in 2021, which allows for portions of the NDA to be submitted as they are completed. The companies expect to complete the submission in the first quarter of 2026 for a priority review.

Contineum misses in midstage MS

Contineum Therapeutics Inc.’s midstage study of its multiple sclerosis drug, PIPE-307, missed its primary and secondary endpoints, dropping the stock at midday. Top-line phase II results from the Vista study of the M1 receptor agonist PIPE-307 for treating relapsing-remitting multiple sclerosis saw no significant changes in binocular 2.5% low contrast letter acuity in the treatment arms. The randomized, double-blind, placebo-controlled, multicenter, proof-of-concept study did, however, produce an acceptable and safety tolerability profile. The development program is a collaboration with Janssen Pharmaceutica NV, a unit of Johnson & Johnson. Contineum’s stock (NASDAQ:CTNM) had taken a nosedive at midday, with shares down 14.6% to $10.43 each.

Scotland sets out 10-year plan to double its life sciences sector

The Scottish government has published a strategy setting out a roadmap to more than double the size of Scotland’s life sciences sector over the next 10 years. The most recent data show the sector currently contributes £10.5 billion (US$13.8 billion) in turnover to the economy, supporting 46,000 jobs. The aim of the strategy is to increase this to £25 billion by 2035. That will be achieved by building new infrastructure and developing skills, while harnessing technologies including AI, engineering biology and gene editing, improving the environment for commercial clinical trials and supporting startups to attract investment and to scale, whilst remaining rooted in the country.

RFK skirts promises: CDC website wording suggests vaccine-autism link

Changes to wording within a U.S. CDC website regarding autism and vaccines has sparked a backlash from numerous scientific and other groups, placing HHS Secretary Robert F. Kennedy Jr. (RFK) in the spotlight once again for appearing to break promises made earlier this year to secure his nomination. Sometime in the last few days the site’s language changed from “Studies have shown that there is no link between receiving vaccines and developing autism spectrum disorder (ASD)” to “The claim ‘vaccines do not cause autism’ is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism.” The Autism Science Foundation said the change shows a lack of understanding of the term “evidence,” stressed that the science is clear, and insisted that no "environmental factor has been better studied."

Rare genetic variants raise the risk of ADHD

A significant share of the risk and heritability of attention-deficit hyperactivity disorder (ADHD) is explained by rare genetic variants. A study led by scientists from Aarhus University in Denmark has uncovered their weight in this condition and identified three variants that will help to better understand their role, the risk of developing it, or its comorbidities, in contrast with the common and more frequent variants associated with ADHD.

Jascayd for idiopathic pulmonary fibrosis among 20 October US approvals

The U.S. FDA approved 20 drugs in October 2025, bringing the year-to-date total to 181 approvals in the first 10 months of the year. Two new molecular entities were approved in the U.S. in October: Boehringer Ingelheim GmbH‘s Jascayd (nerandomilast) for idiopathic pulmonary fibrosis and Bayer AG‘s Lynkuet (elinzanetant) for hot flashes due to menopause.

Also in the news

Accord, Advanz, Alexion, Alvotech, Amgen, Aperture, Applied, Astrazeneca, Bayer, Biovaxys, CASI, Cassidy, Celltrion, Innovent, Jyong, Microbiotix, Moderna, Novartis, Nuvalent, Orbus, Persephone, Regeneron, Revalesio, Thryv, Trioar