https://www.bioworld.com/rss en-us Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Abbvie, Astrazeneca, Bavarian, Biodexa, Cansino, Capricor, Daiichi, Eisai, Lantheus, Larimar, Nuvation, Satellos, Senzime, SOBI, United, Viridian, Zambon. http://www.bioworld.com/articles/732253 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732253-regulatory-actions-for-june-30-2026 Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Best, Biocryst, JATT, Kyowa, Setpoint, Talawar, Universe. http://www.bioworld.com/articles/732252 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732252-other-news-to-note-for-june-30-2026 Clinical updates for biopharma and med tech, including data readouts and publications: AB, Abbott, Astrazeneca, Avecho, Bridgebio, Edwards, Evommune, Fluoguide, Grünenthal, ITM, Johnson, Mdxhealth, Monopar, Neurogene, Neurosense, OTR3, Samsung, Viatris, Zelluna. http://www.bioworld.com/articles/732251 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732251-in-the-clinic-for-june-30-2026 Biopharma and med-tech companies raising money in public or private financings, including: 4DMT, Akari, Biobot, Neurolife. http://www.bioworld.com/articles/732250 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732250-financings-for-june-30-2026 New hires and promotions in the biopharma and med-tech industries, including: Aplagon, Establishment Labs, George Medicines, Kailera, Novabridge, Rani, Tenaya, Xilio. http://www.bioworld.com/articles/732249 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732249-appointments-and-advancements-for-june-30-2026 Top-line phase III Palisade-4 results of Vistagen Therapeutics Inc.’s fasedienol showed the intranasal pherine candidate failed to hit primary and secondary endpoints in the acute treatment of social anxiety disorder (SAD), issuing a near death knell as company’s shares (NASDAQ:VTGN) plunged more than 70% to close at 22 cents on June 30. http://www.bioworld.com/articles/732246 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732246-vistagens-sad-slump-lead-pherine-fasedienol-fails-again Wall Street breathed easier, and shares of Abivax SA found relief as further phase III data from the Abtect maintenance trial were disclosed with obefazimod in ulcerative colitis (UC). http://www.bioworld.com/articles/732245 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732245-relaxed-on-abivax-uc-phase-iii-cancer-answer-quells-fretting The U.S. FDA’s new Precheck Pilot Program is taking flight with seven biopharma companies on board. As part of the Trump administration’s efforts to encourage onshoring of biopharma manufacturing, the program is intended to increase regulatory predictability, facilitate the construction of U.S. manufacturing sites and streamline the FDA’s plant assessments in advance of a specific product application. http://www.bioworld.com/articles/732244 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732244-fda-clears-first-flight-of-precheck-rx-manufacturing-pilot AI, data and wearable technologies are transforming health care, giving patients greater access to information about their health and enabling faster, more responsive clinical trials, Anthony Costello, CEO of Medidata Solutions Inc., told BioWorld. As more people use wearable devices to monitor their health, they are increasingly able to react to those insights, while pharmaceutical companies are gaining a clearer picture how patients respond to treatments during clinical trials. BioWorld. As more people use wearable devices to monitor their health, they are increasingly able to react to those insights, while pharmaceutical companies are gaining a clearer picture how patients respond to treatments during clinical trials.]]> http://www.bioworld.com/articles/732243 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732243-ai-data-and-wearables-transforming-health-care-clinical-trials Digital brain with dollar sign The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded. The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.]]> http://www.bioworld.com/articles/732242 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732242-nejm-paper-on-tavneos-pivotal-trial-retracted-by-academic-authors Photo of pen and marker on science journal article Deep brain stimulation (DBS) through implanted electrodes has enabled fundamentally new ways of treating certain disorders. More than 100,000 severely ill patients have received an implant to treat Parkinson’s disease, which is DBS’ greatest success story. http://www.bioworld.com/articles/732241 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732241-deep-brain-stimulation-from-the-shallows-tomorrows-bci-technology Black wavy lines forming an abstract sound wave.png A preview of the next edition of BioWorld, June 30, 2026 http://www.bioworld.com/articles/732254 Tue, 30 Jun 2026 11:00:00 -0400 https://www.bioworld.com/articles/732254-deep-brain-stimulation-from-the-shallows-tomorrows-bci-technology BioWorld briefs for June 29, 2026. http://www.bioworld.com/articles/432891 Tue, 30 Jun 2026 11:00:00 -0400 https://www.bioworld.com/articles/432891-todays-news-in-brief A U.S. biotechnology company founded by Deerfield Management Company L.P. licensed exclusive rights to Metis Techbio Co. Ltd.’s preclinical trispecific T-cell engager (TCE) for autoimmune disorders in a potential $1.62 billion deal. http://www.bioworld.com/articles/732310 Tue, 30 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732310-deerfield-backed-boulevard-metis-pen-16b-trispecific-tce-deal Handshake, businessmen holding dollar sign, lightbulb The outbreak of hantavirus infection first reported on the MV Hondius cruise ship on May 2 is all but over, with most isolating passengers, crew members and other contacts leaving quarantine over the past week, as the 42-day incubation period drew to an end. http://www.bioworld.com/articles/732078 Tue, 30 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732078-who-to-declare-hantavirus-outbreak-over-as-quarantines-end Hantavirus cells lynn.yoffee@clarivate.com 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. 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.]]> http://www.bioworld.com/articles/732328 Tue, 30 Jun 2026 08:00:00 -0400 https://www.bioworld.com/articles/732328-celebrating-recognition-reaffirming-our-mission Award ribbon icon Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Acadia, Amgen, Arbor, Astrazeneca, Daiichi, Eli Lilly, Everest, Incyte, Johnson, Maat, Omeros, Pharmaessentia, Replimune, Xspray. http://www.bioworld.com/articles/732239 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732239-regulatory-actions-for-june-29-2026 Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: CSL Seqirus, Elixirgen, Incyte, Ipsen, Kartos, Larimar, Nippon, Sanofi, SNT, Waters. http://www.bioworld.com/articles/732238 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732238-other-news-to-note-for-june-29-2026 Clinical updates for biopharma and med tech, including data readouts and publications: Anixa, Castle. Epicrispr. http://www.bioworld.com/articles/732237 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732237-in-the-clinic-for-june-29-2026 Biopharma and med-tech companies raising money in public or private financings, including: Definium, Idorsia, Imagion, Ligand, Nuvation, Proqr, Uniqure. http://www.bioworld.com/articles/732236 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732236-financings-for-june-29-2026 New hires and promotions in the biopharma and med-tech industries, including: Jade, Keros, Ossdsign, Vivani. http://www.bioworld.com/articles/732235 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732235-appointments-and-advancements-for-june-29-2026 With the U.S. FDA go-ahead granted June 26 for Viridian Therapeutics Inc.’s IGF-1R antagonist Lumvoa (veligrotug-vvze, or “veli”) as a new thyroid eye disease (TED) therapy – due to launch immediately, the company said – Wall Street will be watching near-term payer dynamics. The drug is set to take on similarly targeted Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved in January 2020 to treat TED. http://www.bioworld.com/articles/732231 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732231-new-viridian-meridian-hopes-veli-high-in-ted-post-fda-win Illustration of a road with three destination markers 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, according to a company announcement. http://www.bioworld.com/articles/732230 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732230-samsung-bioepis-keytruda-biosimilar-hits-phase-i-iii-endpoints Targets with arrows 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. Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts.]]> http://www.bioworld.com/articles/732229 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732229-the-court-said-what-it-said-dc-circuit-tells-norwich Judge's gavel with US flag Roche Holding AG is looking to take a share of Illumina Inc.’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. http://www.bioworld.com/articles/732228 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732228-roche-launches-axelios-1-sequencing-platform-to-rival-illumina DNA NGS genome sequencing 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. http://www.bioworld.com/articles/732227 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732227-ema-reverses-its-stance-on-acadias-rett-syndrome-therapy-daybu EU flags at European Commission building 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 a way that minimizes the former’s current capital position. http://www.bioworld.com/articles/732226 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732226-zymeworks-bolsters-royalty-stream-with-theravance-buy Acquisition puzzle 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. http://www.bioworld.com/articles/732225 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732225-ascending-bci-systems-deepen-national-security-ethical-concerns Brain made of chip and circuits A preview of the next edition of BioWorld, June 29, 2026 http://www.bioworld.com/articles/732240 Mon, 29 Jun 2026 11:00:00 -0400 https://www.bioworld.com/articles/732240-ascending-bci-systems-deepen-national-security-ethical-concerns The top 10 biopharma stock gainers and losers for the week. http://www.bioworld.com/articles/732234 Mon, 29 Jun 2026 11:00:00 -0400 https://www.bioworld.com/articles/732234-biggest-gainers-and-losers-for-june-22-26-2026