https://www.bioworld.com/rss en-us To Ivan Oransky, China’s paper-mill problem is best understood as an incentives story. “This is literally organized crime,” the Retraction Watch co-founder told BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how often you publish and what journals you publish in and how often you’re cited, it’s not surprising that leads to bad behavior.” BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how often you publish and what journals you publish in and how often you’re cited, it’s not surprising that leads to bad behavior.”]]> http://www.bioworld.com/articles/732415 Fri, 03 Jul 2026 09:00:20 -0400 https://www.bioworld.com/articles/732415-behind-chinas-retractions-a-paper-mill-economy-built-on-incentives China in red on globe Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced licensing deal with Johnson & Johnson subsidiary Mentor Worldwide LLC positioning the technology for global commercialization. http://www.bioworld.com/articles/732275 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732275-bellaseno-speeds-breast-scaffold-trial-as-j-and-j-deal-clears-path-to-market Illustration of Bellaseno's scaffold placed in the breast Bellaseno’s regenerative absorbable breast scaffold. Credit: Bellaseno. To Ivan Oransky, China’s paper-mill problem is best understood as an incentives story. “This is literally organized crime,” the Retraction Watch co-founder told BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how often you publish and what journals you publish in and how often you’re cited, it’s not surprising that leads to bad behavior.” BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how often you publish and what journals you publish in and how often you’re cited, it’s not surprising that leads to bad behavior.”]]> http://www.bioworld.com/articles/732273 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732273-behind-chinas-retractions-a-paper-mill-economy-built-on-incentives China in red on globe 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 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 The data mill continues to churn out encouraging results in pancreatic ductal adenocarcinoma (PDAC), with shares of Ramat Gan, Israel-based Can-Fite Biopharma Ltd. benefiting from the latest, phase IIa dispatch that pushed shares (NYSE:CANF) up 58%, or $1.73, to close July 1 at $4.70. http://www.bioworld.com/articles/732256 Wed, 01 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732256-yes-we-can-fite-pdac-phase-iia-results-add-momentum Illustration of cancer in the pancreas 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. 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.]]> http://www.bioworld.com/articles/732353 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732353-high-profile-retraction-tests-confidence-in-china-led-studies Retraction spelled out on typewriter 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 Corxel Pharmaceuticals Ltd.’s oral small-molecule GLP-1 receptor agonist, CX-11, met the primary endpoints in a phase II trial evaluating the candidate in obese and overweight patients in the U.S., according to top-line results. http://www.bioworld.com/articles/732349 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732349-corxel-vincentages-oral-glp-1-meets-phase-ii-obesity-endpoints Glass of water and tablets 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 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 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 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 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 BioWorld tracked 262 clinical trial readouts across phases I through III in May 2026, the highest monthly total so far this year and well above April’s 143, March’s 209, February’s 152 and January’s 144. By phase, BioWorld recorded 98 phase I readouts in May, 81 in phase II and 83 in phase III. Of the phase III programs, 17 trials posted positive results, and one failed to meet its primary endpoints. BioWorld tracked 262 clinical trial readouts across phases I through III in May 2026, the highest monthly total so far this year and well above April’s 143, March’s 209, February’s 152 and January’s 144. By phase, BioWorld recorded 98 phase I readouts in May, 81 in phase II and 83 in phase III. Of the phase III programs, 17 trials posted positive results, and one failed to meet its primary endpoints.]]> http://www.bioworld.com/articles/732176 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732176-phase-iii-wins-in-may-span-gene-therapy-gout-and-pancreatic-cancer Lab vials and dropper 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 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. 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.]]> http://www.bioworld.com/articles/732172 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732172-high-profile-nature-retraction-tests-confidence-in-china-led-studies Retraction spelled out on typewriter The field of BCI is continually evolving; as such, companies are increasingly highlighting the potential of their technologies to transform care. For advanced players, with fully developed BCI systems, the sector is approaching an inflection point as the technology transitions from early feasibility studies into pivotal trials. The focus now for many is on generating the long-term safety, efficacy and real-world usability data needed to support regulatory approval and broader clinical adoption. http://www.bioworld.com/articles/732074 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732074-brain-computer-interfaces-are-here-but-long-road-ahead Cortec Brain Interchange BCI system Cortec’s Brain Interchange system is a fully implantable, wireless, bidirectional closed-loop platform that records neural activity and delivers stimulation through soft subdural electrocorticography electrodes, without penetrating brain tissue. Credit: Cortec GmbH Corxel Pharmaceuticals Ltd.’s oral small-molecule GLP-1 receptor agonist, CX-11, met the primary endpoints in a phase II trial evaluating the candidate in obese and overweight patients in the U.S., according to top-line results. http://www.bioworld.com/articles/732050 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732050-corxel-vincentages-oral-glp-1-meets-phase-ii-obesity-endpoints Glass of water and tablets Neither of Cynata Therapeutics Ltd.’s pivotal trials for its Cymerus stem cell platform met the primary endpoints, with no statistically significant differences between active and control groups on primary or key secondary efficacy measures, CEO Kilian Kelly told investors during a June 22 conference call. http://www.bioworld.com/articles/732155 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732155-cynatas-cymerus-flops-in-osteoarthritis-gvhd Stem cells J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/732153 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732153-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts 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. 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.]]> http://www.bioworld.com/articles/732062 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732062-2026-marks-critical-turning-point-for-bci-technology Patient using Neuracle NEO system A patient grasps a bottle with a prosthetic hand using Neuracle’s NEO system, codeveloped by Tsinghua University School of Medicine. Credit: Tsinghua University Missing statistical significance on the primary overall survival phase III endpoint with antibody-drug conjugate (ADC) sigvotatug vedotin 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. http://www.bioworld.com/articles/732060 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732060-pfizer-adc-from-seagen-m-and-a-fails-in-phase-iii-nsclc-trial Lung cancer illustration Neither of Cynata Therapeutics Ltd.’s pivotal trials for its Cymerus stem cell platform met the primary endpoints, with no statistically significant differences between active and control groups on primary or key secondary efficacy measures, CEO Kilian Kelly told investors during a June 22 conference call. http://www.bioworld.com/articles/732047 Mon, 22 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732047-cynatas-cymerus-flops-in-osteoarthritis-gvhd Stem cells Definium Therapeutics Inc. CEO Rob Barrow hailed a “profound change” in the treatment of major depressive disorder (MDD) as his firm rolled out positive top-line results from Emerge, the first randomized, double-blind, placebo-controlled phase III study evaluating a single dose of DT-120 (lysergide, otherwise known as LSD), given to adults as an orally disintegrating tablet 100 µg. http://www.bioworld.com/articles/732044 Mon, 22 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732044-definiums-phase-iii-lsd-emerges-as-top-mdd-player Hands holding tablet and glass of water J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/731921 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731921-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug in more than two decades. Along with partner Shionogi & Co. Ltd., F2G has released positive phase III results for orally administered olorofim, showing noninferiority against I.V.-administered Ambisome (amphotericin B, Gilead Sciences Inc.) in patients with refractory aspergillosis infections, or who were unsuitable for mainstay azole therapy. http://www.bioworld.com/articles/731918 Thu, 18 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731918-f2g-preps-nda-for-first-new-antifungal-in-20-years-on-solid-phase-iii Aspergillus fumigatus HMNC Brain Health GmbH has raised $50 million in the first close of a series B, enabling the company to prepare the way for phase III trials of its two lead programs. http://www.bioworld.com/articles/731906 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731906-hmnc-raises-50m-series-b-to-prep-depression-drugs-for-phase-iii Blue-gray dollar sign