Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are sparking concerns over public health, ethics and national security. Current BCI technology works to enable unilateral communication between human and machine: taking what is inside the brain (thoughts) and externalizing it to control an external device (prosthetic arms or robots). The future of BCI, according to Im Chang-Hwan, biomedical engineering professor at Hanyang University, will come down to whether information and external stimuli can also be pushed inside the brain. This bidirectional communication between the brain and AI would enable telepathy, or direct communication between one AI-linked brain to another, as well as between AI devices.

Viridian’s Lumvoa gains FDA nod to take on Tepezza in TED

The U.S. FDA cleared Viridian Therapeutics Inc.’s IGF-1R antagonist Lumvoa (veligrotug-vvze) for thyroid eye disease (TED), setting the drug up to compete with Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved for TED in January 2020. Waltham, Mass.-based Viridian’s green light for its first commercial product was widely expected, and shares (NASDAQ:VRDN) were trading at $19.81, up $1.91, or 10%. Lumvoa’s label bears “broadly similar safety language (warnings and precautions [to Tepezza]), in-line with our expectations,” Leerink analyst Thomas Smith observed in a report. The drug is also the first given FDA clearance to show a statistically significant effect in diplopia (double vision) response and complete resolution of diplopia in active as well as chronic forms of TED. For wider access to Lumvoa, Viridian has created Viridiancares, which CEO Steve Mahoney called a “white-glove” patient-support program.

Zymeworks bolsters royalty stream with Theravance buy

One company was looking to add to its royalty stream and R&D portfolio. The other was seeking strategic alternatives in the wake of clinical misfires over the last few years. In an agreement aimed at satisfying both goals, Zymeworks Inc. will acquire Theravance Biopharma Inc., paying $17 per share, or about $929 million, though the transaction is structured in way that minimizes the former’s current capital position. In exchange, Zymeworks gains rights to Yupelri (revefenacin), a nebulized bronchodilator approved for chronic obstructive pulmonary disorder (COPD), as well milestone payments related to sales of Trelegy Ellipta (umeclidinium bromide/vilanterol trifenate/fluticasone furoate, GSK plc) and royalties on sales of Vibativ (telavancin, Cumberland Pharmaceuticals Inc.). The acquisition also brings aboard other R&D-stage assets. Though shares of both firms were trading down on the news, Zymeworks executives stressed the financial arrangement of the deal. “We think we got a lot for what we were able to spend,” CEO Ken Galbraith told investors on a morning conference call.

EMA reverses its stance on Acadia’s Rett syndrome therapy, Daybu

Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file. While the pivotal trial of Daybu met the co-primary endpoint and key secondary endpoints, when CHMP first reviewed the marketing application it concluded the treatment effect after 12 weeks was limited in magnitude and did not capture all the core symptoms of Rett syndrome. After re-examining the file, CHMP has changed its stance, saying that “although the effect sizes were small, their clinical relevance was considered acceptable based on the totality of data.”

CINP 2026: Gut microbiota could predict antidepressant response

The gut microbiota may be altered in people with depression as a result of treatment. These microorganisms reorganize differently in individuals who respond to therapy. In a multiomics study of antidepressant-naive patients presented at the 2026 World Congress of Neuropsychopharmacology (CINP), scientists from National Taiwan University found that patients who improved after antidepressant treatment maintained a more balanced and functional microbial ecosystem, recovered beneficial metabolites, and displayed blood-based biological signals that aligned with these changes. The researchers suggest that treatment response depends on a finely tuned dynamic interaction between the microbiota, metabolites and host proteins. “We have observed a lot of patient heterogeneity in the efficacy of [antidepressants] and we are trying to understand why they have these differences,” first author Shih Kai Kevin Lin, researcher at the Institute of Epidemiology and Preventive Medicine, Department of Public Health at National Taiwan University, told BioWorld.

Roche launches Axelios 1 sequencing platform to rival Illumina

Roche is looking to take a share of Illumina’s dominance in the gene sequencing market with the launch of Axelios 1, its next-generation sequencing (NGS) platform designed for accuracy, speed, flexibility, scalability and cost efficiency. The move signals a potential shift in the sequencing landscape as the technology aims to address critical bottlenecks in genomics, offering the flexibility to handle smaller, faster batches or larger projects without changing systems or workflows, and it is capable of producing whole‑genome results in a day.

Samsung Bioepis’ Keytruda biosimilar hits phase I, III endpoints

Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product. The top-line readout makes Incheon, South Korea-based Samsung Bioepis the first among Keytruda biosimilar developers to report clinical equivalence data from a global late-stage study.

DC Circuit reminds Norwich of the ‘skinny’ in ANDA game

While the U.S. Supreme Court made it clear earlier this month in Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts. In an opinion handed down June 26, the U.S. Court of Appeals for the District of Columbia (DC) Circuit told Norwich Pharmaceuticals Inc. that it can’t simply amend its ANDA to carve out a patent-protected indication to get around a lower court order, as it cannot pass “go” without a whole new ANDA. While the DC Circuit opinion is case-specific, it could be instructive to other generic companies eyeing a skinny label move.

Celebrating recognition. Reaffirming our mission.

Awards are an honor, but they are not why we do what we do. That's why this year's recognition from the APEX Awards is especially meaningful. BioWorld earned seven 2026 APEX Awards, including three Grand Awards and four Awards of Excellence. Judged by publishing industry peers, these honors recognize excellence across reporting, writing, visual storytelling and editorial collaboration. While we are proud of this recognition, what makes it especially rewarding is that it reflects the work our team does every day to serve the global life sciences community.

Also in the news

Amgen, Anixa, Aplagon, Arbor, Astrazeneca, Castle, Chiesi, CNX, CSL, Daiichi Sankyo, Definium, Eli Lilly, Elixirgen, Epicrispr, Establishment Labs, Everest Medicines, George Medicines, Idorsia, Imagion, Incyte, Ipsen, Jade, Johnson & Johnson, Kailera, Kartos, Keros, Larimar, Legacy, Ligand, Lucence, Maat, Nippon Shinyaku, Novabridge, Nuvation, Omeros, Ossdsign, Pharmaessentia, Proqr, Rani, Replimune, Sanofi, SNT, Tenaya, Vivani Medical, Xilio, Xspray