Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
Neuralink launches first UK trial of brain chip
Neuralink is launching its first European clinical trial in the UK, recruiting seven patients with severe paralysis to test its fully implantable brain-computer interface (BCI). The study is a clinical extension of its ongoing US-based PRIME trial, which began in 2023 under FDA approval and evaluated the safety and early functionality of its N1 chip and surgical R1 robot. Partnering with University College London Hospitals and Newcastle upon Tyne Hospitals NHS Foundation Trust, the company will assess whether the device can enable people to control digital tools using only their thoughts. Once implanted, the coin-sized device wirelessly transmits neural data to an app that converts thought into control of a cursor or keyboard. Backed by a $650 million funding round, Neuralink says the goal is to restore digital autonomy for patients with quadriplegia from spinal cord injuries or ALS. – Bree Foster
Trump threatens 250 percent pharma tariffs
President Trump told CNBC this week that tariffs on imported pharmaceuticals could eventually rise to 250 percent, beginning with a small initial levy and increasing over the next 12 to 18 months. Framing the move as a push to bring drug manufacturing back to the US, Trump cited national security concerns and criticized high domestic drug prices, referencing his earlier executive order on “most-favored-nation” pricing. While the administration hasn’t finalized the policy, Trump claimed it would significantly lower medicine costs. For developers, the proposed tariffs could undercut global manufacturing strategies, drive up development costs, and complicate efforts to bring new therapies to market. Drugmakers have also warned the proposed tariffs could raise prices, disrupt supply chains, and deter investment. The industry is also weighing a recent letter from the administration urging them to match global drug prices for US Medicaid patients by September. – Andrea Corona
FDA clears Roche’s assay to test four respiratory viruses at once
Roche announced that the FDA cleared their cobas Respiratory 4-flex, the first respiratory test using their temperature-activated generation of signal (TAGS) technology. By using multiplex PCR testing along with data processing of color and temperature, the test is able to detect the four most common respiratory pathogens in one go: SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV). In the press release, Brad Moore, President and CEO of Roche Diagnostics North America, said, "The cobas Respiratory 4-flex assay offers a significant technological advancement that empowers labs to address evolving respiratory testing demands now and in the future.” – Allison Whitten
Merck bets $10B on COPD drug in Verona deal ahead of Keytruda cliff
Merck’s planned $10 billion acquisition of Verona Pharma, announced in July and expected to close in Q4 2025, reflects continued consolidation in respiratory drug development as Big Pharma hunts for differentiated, late-stage assets. The deal adds Ohtuvayre (ensifentrine), the first dual PDE3/4 (phosphodiesterase 3 and phosphodiesterase 4) inhibitor approved by the FDA for chronic obstructive pulmonary disease (COPD), to Merck’s pipeline amid looming revenue pressure from Keytruda’s patent expiry. With Ohtuvayre showing strong early sales post-US launch in August 2024, the move highlights the pressure on smaller biotechs to deliver Phase 3 wins and regulatory traction in a capital-constrained environment. – Andrea Corona
Gates Foundation commits $2.5 billion to 'ignored' women's health
The Gates Foundation will invest $2.5 billion in women’s health by 2030, targeting more than 40 innovations in five critically neglected areas, especially those affecting women in low- and middle-income countries. Despite the global burden of conditions like preeclampsia, gestational diabetes, endometriosis, and menopause, these issues are still dramatically underfunded. A 2021 McKinsey-led analysis found that just one percent of healthcare research and development spending goes toward female-specific conditions outside oncology. “Investing in women’s health has a lasting impact across generations,” said Bill Gates in the press release. “Yet women’s health continues to be ignored, underfunded, and sidelined.” The initiative will fund breakthroughs in areas such as the vaginal microbiome, non-hormonal contraception, and first-in-class treatments for pregnancy complications like preeclampsia. – Bree Foster
Rare brain cancer gains oral drug approval
On Wednesday, the FDA approved Jazz Pharmaceuticals’ drug, Modeyso (dordaviprone), to treat a rare type of brain cancer caused by a mutation in the H3 K27M (histone 3 lysine27-to-methionine) gene. This kind of diffuse midline glioma primarily affects children and young adults and often progresses rapidly, with around 2,000 new cases per year in the US. The approval of the once-weekly oral drug was based on five open-label trials with 50 patients who showed a 22 percent overall response rate. Patients who did respond showed a median response duration of 10.3 months. In a press release, Jazz said that they expect Modeyso to become commercially available in the coming weeks. "This is a major turning point in neuro-oncology … This therapy was developed with the underlying biology of the tumor in mind and introduces a new treatment option for a population with historically limited choices," said Patrick Wen, a neurologist at the Dana-Farber Cancer Institute and Harvard Medical School, in the press release. Jazz recently acquired the drug from its $935 million buyout of Chimerix in March of this year. – Allison Whitten
