Decades of research are helping unravel the “black box” of the brain. The second article in BioWorld’s series on the Brain-Computer Interface (BCI) field looks at how simultaneous breakthroughs in AI technology are pushing the BCI field from a theoretical concept to a potential real-world, clinical option for individuals, particularly in China where the National Medical Products Administration greenlighted the world’s first invasive BCI system – Neuracle Medical Technology Co. Ltd.’s Neural Electronic Opportunity – for clinical use in March 2026.

Pfizer ADC, from Seagen M&A, fails in phase III NSCLC trial

Missing statistical significance on the primary overall survival phase III endpoint with antibody-drug conjugate sigvotatug vedotin (SV) compared with docetaxel in non-small-cell lung cancer (NSCLC), Pfizer Inc., which gained the candidate through its $43 billion buyout of Seagen Inc. in 2023, is forging ahead based on subgroup signals, phase I data and an ongoing phase III Keytruda combination effort currently underway. The Sigvie-002 (formerly Be6A-Lung-01) study enrolled 703 adults with previously treated, locally advanced, unresectable or metastatic NSCLC. SV failed to clear the hurdle of overall survival (OS) in the overall population, though it did exhibit what Pfizer called “a stronger trend” for OS and progression-free survival among patient who had received only one prior line of systemic therapy – about two-thirds of the study population – as opposed to those who were third-line or later. While safety was manageable and appeared consistent with prior studies, the trial showed no clear integrin beta-6 expression-response relationship. Pfizer Chief Oncology Officer Jeff Legos noted, “Patients with previously treated advanced NSCLC are a historically difficult-to-treat population, and there is clearly more work to be done to improve the outcomes for this population.”

China approves first CAR T for solid tumors

China’s National Medical Products Administration approved Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T was approved for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy. “The approval and launch of satri-cel is an important milestone marking the advancement of CAR T-cell therapy from hematologic malignancies to solid tumors,” said Carsgen CEO Zonghai Li. Carsgen is also exploring the therapy in first-line sequential and postoperative adjuvant settings in advanced gastric cancer.

SK Biopharm taps Insilico in $2.5B AI CNS drug discovery deal

SK Biopharmaceuticals Co. Ltd. is doubling down on AI-powered drug discovery through a new collaboration with Insilico Medicine Inc. valued at more than $2.5 billion. The milestone-heavy deal, announced at the BIO International Convention in San Diego June 22, will pair Insilico’s Pharma.AI platform with SK Biopharm’s central nervous system drug development and commercialization capabilities, underscoring Korean and global biopharma efforts to embed AI across the entire R&D lifecycle. It also plays into SK Biopharm’s ambition to “leap forward as a big biotech” with new, innovative assets and a particular focus on AI.

Croívalve secures $27M for Duo Adapt tricuspid device

Croívalve Ltd. secured a further $20 million in series B financing for its Duo Adapt system, a transcatheter device that treats tricuspid regurgitation. The company also received $7 million from the European Innovation Council and the Disruptive Technologies Innovation Fund in grant financing. Croívalve will use the funds to expand its clinical study, which is evaluating the safety and performance of the Duo adapt system in patients with severe or greater symptomatic tricuspid regurgitation.

FDA looks to pilot speedier early stage Rx development

With increasing competition from China and other countries, the U.S. Department of Health and Human Services is rolling out a department-wide strategy to once again make the U.S. the go-to destination for early stage drug development. That strategy includes the FDA clarifying its regulatory expectations for sponsors that could reduce early trial timelines by six to 12 months. The agency also is requesting comments about the shape of a proposed expedited IND pilot program aimed at reducing the time from identifying a promising drug candidate to a first-in-human trial – a milestone crucial to raising capital.

EFPIA report: Every €1 spent on new drugs returns €5.67 to Europe’s economy

The industry is stepping up its campaign to persuade European governments to increase their drugs budgets, in what is described as a landmark report making the case that spending on patented drugs is not a cost to be contained, but an investment in health and the economy. The report was commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA), in a bid to challenge the policy imperative that healthcare budgets should be constrained as much as possible.

US FDA approves 24 drugs in May in busiest month of 2026

May was the busiest month of the year so far for U.S. FDA drug approvals, pushing the year-to-date total to 84 approvals and 20 new molecular entities through five months. Globally, drug approvals reached 43 in May, bringing the worldwide year-to-date count to 197.

Going after gonorrhea with artificial intelligence

Researchers at the Wyss Institute of Harvard University have used a mix of machine learning and classical screening techniques to identify small molecules that were effective against Neisseria gonorrhoeae in vagina-on-a-chip and mouse models of infection. Their findings were published in the June 17, 2026, issue of Science Translational Medicine.

Also in the news

Achieve, Betterlife, Bioarctic, Biond, Carsgen, Cervomed, Colospan, Definium, Eledon, Eli Lilly, Exelixis, Exeltis USA, Galmed, Gondolabio, Haisco, Histosonics, Imperative, Incyte, Kither, Kyverna, Ligand, Maplight, Masimo, Memento, Merck, Merz, Moderna, Moonlake, Nura, Novo Nordisk, Nuvectis, Parexel, Praxis, Regeneron, Revolution, Sanofi, Sophia Genetics, Spruce, Sumitomo, Synta, Syntax, Taysha, Teijin, Tetmedical, Teva, Tscan, Uniqure, Viiv, Xeos