https://www.bioworld.com/rss en-us Despite the Biosecure Act’s five-year wind-down period that isn’t expected to start until mid-2028, Wuxi Apptec is already feeling the repercussions of being added last month to the U.S. Department of War’s Section 1260H list. Instead of just waiting for its June 11 challenge to its listing as a “Chinese military company” to play out in court, the Shanghai-based contract research, development and manufacturing organization (CRDMO) is now seeking a preliminary injunction to suspend the designation during the court proceedings. http://www.bioworld.com/articles/732276 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732276-wuxi-apptec-seeks-immediate-relief-from-us-listing Legal scales and clipboard With more and more approved products, cell and gene therapies (CGTs) are moving from the initial stronghold in academic medical centers, and these complex biologics are now available across a wider network of treatment centers. http://www.bioworld.com/articles/732272 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732272-cell-and-gene-therapy-access-is-up-but-capacity-constraints-may-be-looming Stem cells and DNA Veterans in the U.S. suffering from post-traumatic stress disorder (PTSD) now have access to Neurovalens Ltd.’s Modius Spero, a wearable neuromodulation device, which can reduce their symptoms in as little as four weeks. The treatment, designed for at-home use of 30-minute daily sessions, was approved for use within the Department of Veterans Affairs after the company secured FDA de novo clearance. http://www.bioworld.com/articles/732270 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732270-neurovalens-brings-fda-cleared-ptsd-therapy-to-us-veterans Modius Spero wearable neuromodulation device Neurovalens Ltd.’s Modius Spero wearable neuromodulation device. Credit: Neurovalens. Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients. http://www.bioworld.com/articles/732269 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732269-genentechs-kras-g12c-inhibitor-divarasib-shines-in-nsclc-phase-iii Illustration of lungs with cancer inset Regardless of whether the Republicans or Democrats come out on top in November’s midterm congressional elections, some of the state primaries in the U.S. have already guaranteed major shuffles in key House and Senate committees overseeing national health issues. http://www.bioworld.com/articles/732262 Wed, 01 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732262-us-primaries-continue-to-rattle-congressional-health-leadership U.S. Capitol building Zimmer Biomet Holdings Inc.’s deal to buy Pacira Biosciences Inc.’s Iovera system for up to $140 million and Eurobio Scientific SA’s acquisition of Caredx Inc.’s lab products business for $171.2 million are symptomatic of a broader trend among med-tech and diagnostics companies using targeted acquisitions to strengthen specific areas of their portfolio. http://www.bioworld.com/articles/732261 Wed, 01 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732261-cool-move-by-zimmer-part-of-med-techs-tuck-in-deals-trend Handshake icon engraved on metal hexagonal background The House Select Committee on China launched an investigation into clinical trials involving U.S. companies that are conducted at Chinese military hospitals and in Xinjiang, China. http://www.bioworld.com/articles/732259 Wed, 01 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732259-some-clinical-trials-in-china-under-us-congressional-scrutiny China and U.S. flags Orca Bio Inc. is bringing to market a precision-engineered cell therapy approach designed to improve outcomes in patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) following U.S. FDA approval of Tregzi, a first-of-its-kind, personalized cell therapy. http://www.bioworld.com/articles/732255 Wed, 01 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732255-orcas-t-cell-therapy-approach-to-hsct-wins-fda-nod-as-tregzi FDA approval seal on blue glittering background 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. http://www.bioworld.com/articles/732352 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732352-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD 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/732351 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732351-samsung-bioepis-keytruda-biosimilar-hits-phase-i-iii-endpoints Targets with arrows The oversubscribed $330 million series B round secured by Ollin Biosciences Inc. marks more than another large venture round in ophthalmology. It also highlights an emerging biotech financing model in which Chinese pharma companies discover and clinically validate promising drugs before handing global development to well-capitalized U.S. startups backed by blue-chip venture investors. http://www.bioworld.com/articles/732350 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732350-ollins-330m-series-b-underscores-rise-of-china-origin-newco-model Close-up of a human eye featuring a dollar sign in the iris Nuvectis Pharma Inc.’s shares climbed further after the oncology-focused biotech nabbed select rights to a late-stage complement factor B inhibitor (HSK-39297/NXP-100) and a phase I BRAF inhibitor (HSK-42360/NXP-200) from Haisco Pharmaceutical Group Co. Ltd. for $40 million up front. http://www.bioworld.com/articles/732348 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732348-nuvectis-shares-continue-to-rally-after-146b-haisco-deal Dollar symbol with arrow graph Abbisko Therapeutics Co. Ltd. has entered a research collaboration and license agreement with Eli Lilly and Co. to discover and develop innovative medicines across multiple targets, with the aim of advancing novel drug candidates with global potential. http://www.bioworld.com/articles/732347 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732347-lilly-taps-abbisko-for-19b-discovery-deal Microscope 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 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 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 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 Viridian Therapeutics Inc.’s U.S. FDA clearance of Lumvoa (veligrotug-vvze) to treat thyroid eye disease (TED) includes labeling for chronic as well as active forms, and fewer infusions – plus fast, durable effects – should give the IGF-1R antagonist leverage in competing with similarly targeted TED drug Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved in January 2020. http://www.bioworld.com/articles/732326 Sun, 28 Jun 2026 00:00:00 -0400 https://www.bioworld.com/articles/732326-fda-says-yes-to-viridians-lumvoa-in-ted Close up of man's eye 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. http://www.bioworld.com/articles/732174 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732174-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD The EMA is recommending withdrawing Amgen Inc.’s complement inhibitor Tavneos (avacopan) 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.” http://www.bioworld.com/articles/732171 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732171-ema-to-pull-amgens-tavneos-over-incorrect-and-misleading-data Tavneos Credit: Amgen Inc. 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. http://www.bioworld.com/articles/732170 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732170-investors-bet-on-transformative-bci-tech-for-neuro-disorders Digital brain with dollar sign A year and a half from its formation, Oblenio Bio has generated positive nonhuman primate data for LBL-051 in chronic autoimmune diseases and closed a $62 million series B to move the trispecific T-cell engager into the clinic. http://www.bioworld.com/articles/732274 Fri, 26 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732274-oblenios-62m-series-b-for-trispecific-antibody-in-autoimmune-diseases Antibodies illustration Adhesives innovator H.B. Fuller Co. is offering £2.85 per share in cash to buy Advanced Medical Solutions Group plc, expanding its technologies, commercial footprint and manufacturing capabilities across the globe. http://www.bioworld.com/articles/732163 Thu, 25 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732163-advanced-medical-solutions-takeout-offer-worth-659m Acquisition target A year and a half from its formation, Oblenio Bio has generated positive nonhuman primate data for LBL-051 in chronic autoimmune diseases and closed a $62 million series B to move the trispecific T-cell engager into the clinic. http://www.bioworld.com/articles/732161 Thu, 25 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732161-oblenios-62m-series-b-for-trispecific-antibody-in-autoimmune-diseases Antibodies illustration