An estimated $2 billion has been invested in the brain-computer interface (BCI) space in the last two years and the level of funding is expected to continue. Investors are betting that a deeper understanding of the brain will allow BCI systems to address the significant unmet need affecting millions of people with neurological disorders. They are also chasing an opportunity where the market for BCIs could reach $400 billion – in the U.S. alone. Alumni Ventures has invested in four BCI companies from non-invasive wearables to deep brain implants, including Cala Health Inc., Axoft Inc., Synchron Inc. and Precision Neuroscience Corp. Luca Giani, a senior principal at the firm, told BioWorld that the potential of the technology to transform care is the driving force behind the firm’s investment in the space.

EMA urges market withdrawal of Amgen’s Tavneos

The EMA is recommending withdrawing Amgen’s Inc.’s complement inhibitor Tavneos (avacopan), a treatment for two rare and severe forms of vasculitis, active granulomatosis with polyangiitis or microscopic polyangiitis, from the market in Europe, saying data provided at the time it assessed the MAA “were found to be incorrect and misleading and could no longer be relied upon for demonstrating Tavneos’ effectiveness.” This follows a review that began in January after questions were raised about the integrity of the data in the Advocate study on which the EMA approval was based. The EMA’s appraisal of Tavneos chimes with that of the FDA’s Center for Drug Evaluation and Research, which recommended in April that Tavneos be withdrawn.

High-profile Nature retraction tests confidence in China-led studies

Nature Medicine has retracted a widely publicized Chinese lung cancer study that suggested administering immunotherapy before 3 p.m. could dramatically improve survival in a decision that comes amid heightened scrutiny of research integrity and data transparency in high-impact biomedical journals. The study, known as Lungtime-C01, was published in February and drew international attention after reporting that patients with advanced non-small-cell lung cancer, treated with PD-1 inhibitors plus chemotherapy earlier in the day, had significantly longer progression-free and overall survival than those treated after 3 p.m. The findings were viewed by some researchers as potentially practice-changing. The episode comes as China has become one of the world's largest generators of oncology clinical trials, making questions of transparency, data integrity and international confidence increasingly important for drug developers, regulators and investors.

BIO 2026: Alternatives to funding orphan drugs

At the BIO International Convention, nonprofit and for-profit companies discussed ways to fund orphan drug development, especially for ultrarare diseases where recovering development costs can be challenging. And they’re finding early success, from Alpharose Therapeutics’ model focused on oligonucleotides to Angelman Syndrome Therapeutics’ platform agnostic, disease specific model to Orphan Therapeutics Accelerator, which is partially funded by its commercialization subsidiary Orphan Therapies.

Otsuka’s centanafadine scores in ADHD, comorbid anxiety trial

Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.

J&J brings dual-energy cardiac ablation technology to Europe

Johnson & Johnson this week launched its dual-energy Thermocool Smarttouch SF platform in Europe, bringing another to option to physicians looking to enhance their electrophysiology procedures. The system combines radiofrequency and pulsed field ablation in one device to treat atrial fibrillation, entering what is becoming an increasingly crowded market for cardiac ablation technology.

Phase III wins in May stretch from gene therapy to gout

Oncology dominated May's clinical trial activity, accounting for the largest share of updates across every phase tracked: 54 in phase I, 23 in phase II and 25 in phase III. Phase III successes spanned a broad range of conditions, from Regenxbio Inc.'s gene therapy in Duchenne muscular dystrophy to Swedish Orphan Biovitrum AB's pozdeutinurad for gout.

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