https://www.bioworld.com/rss en-us The industry is in support of the EU Biotech Act but says it needs to go further to restore Europe’s competitive position in biopharma. Instead of incremental adjustments, there should be wide-ranging change to create a system that supports the full lifecycle of drug development, from academic research and clinical development, to manufacturing and commercialization. http://www.bioworld.com/articles/731815 Fri, 12 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731815-industry-calls-for-greater-competitiveness-incentives-in-eu-biotech-act Syringe and vaccine with EU flag In a repeat move, the U.S. FDA issued yet again a complete response letter (CRL) to Camurus AB for its subcutaneous extended-release injection drug CAM-2029 (octreotide) to treat the rare chronic growth disorder acromegaly. The drug, which expects to be branded Oclaiz in the U.S. upon approval, is called Oczyesa in the EU and the U.K., where it received marketing authorization in 2025. http://www.bioworld.com/articles/731805 Thu, 11 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731805-another-fda-no-for-camurus-monthly-acromegaly-drug-oclaiz FDA icons and doctor Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device using spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions need further investigation. With skin cancer rates rising, the Dermasensor joins several other AI-based tools entering the European market to help with the analysis of suspicious lesions. http://www.bioworld.com/articles/731800 Thu, 11 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731800-dermasensor-receives-ce-mark-for-skin-cancer-detection-device Dermasensor device Dermasensor's skin cancer detection device. Credit: Dermasensor Inc. Two companies with European ties signed billion-dollar deals with large pharma firms in the last two days to discover and develop molecular glue drugs, as well as to advance a preclinical Alzheimer’s disease prospect. For both companies, the up-front payments are relatively small, only $10 million for Alzecure Pharma AB, and just $40 million for Orionis Biosciences Inc. But it’s the back-end milestone amounts that are headline-grabbing. http://www.bioworld.com/articles/731722 Wed, 10 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731722-europes-alzecure-orionis-in-1b-deals-with-lilly-novartis Purple molecules Investors in Dianthus Therapeutics Inc. apparently chose to ignore subtleties in the difference between efforts with that firm’s claseprubart vs. those by competitor Sanofi SA, which said that the phase III Mobilize study testing riliprubart in chronic inflammatory demyelinating polyneuropathy (CIDP) will be stopped for futility. http://www.bioworld.com/articles/731720 Wed, 10 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731720-sanofi-phase-iii-cidp-quit-dents-dianthus-c1-mismatch 3D illustration of a nerve cell After a major breach of trust when its data were advertised for sale in China, the UK Biobank will now attempt to recall data previously downloaded by legitimate researchers and seek assurances information has been deleted from local servers. http://www.bioworld.com/articles/731831 Tue, 09 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731831-uk-biobank-seeks-to-recall-downloads-after-health-data-breach Data breach - red broken padlock Extracellular matrix specialist Engitix Ltd. is teaming up with GSK plc to delve into the mechanisms underlying regression of fibrosis after treatment for chronic liver disease, and identify and validate new drug targets involved in this process. http://www.bioworld.com/articles/731693 Mon, 08 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731693-engitix-seals-gsk-deal-for-targets-to-reverse-liver-fibrosis Liver Building on its partnerships with Gilead Sciences Inc., Sanofi SA and Pfizer Inc., Nurix Therapeutics Inc. brought on Roche Holding AG to help develop bexobrutideg, an oral degrader of Bruton’s tyrosine kinase (BTK). “I really can’t think of a better partner to maximize the opportunity for bexobrutideg to a wide range of patients,” Jason Kantor, Nurix’s chief business officer, told investors on a conference call, later pointing out that Roche has multiple drugs targeting B cells. http://www.bioworld.com/articles/731690 Mon, 08 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731690-nurix-signs-4th-and-largest-partnership-to-develop-btk-degrader Gold chain link engraved with "partnership" After a major breach of trust when its data were advertised for sale in China, the UK Biobank will now attempt to recall data previously downloaded by legitimate researchers and seek assurances information has been deleted from local servers. http://www.bioworld.com/articles/731631 Fri, 05 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731631-uk-biobank-seeks-to-recall-downloads-after-health-data-breach Data breach - red broken padlock Roche Holding AG has rapidly developed a research-use only molecular PCR test to detect the rare Ebola Bundibugyo virus, to support response efforts amid the ongoing outbreak in the Democratic Republic of Congo and Uganda. The test comes as commentary in The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus. The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus.]]> http://www.bioworld.com/articles/731630 Fri, 05 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731630-roche-develops-pcr-test-to-detect-the-ebola-bundibugyo-virus Swab sample and patient Antibody-drug conjugate (ADC) specialist Ona Therapeutics SL has closed an oversubscribed series B at $86.6 million, as clinical development of the lead program ONA-255 in advanced treatment-resistant breast cancer gathers steam. http://www.bioworld.com/articles/731620 Thu, 04 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731620-ona-raises-866m-series-b-for-adcs-to-treat-advanced-cancers 3D dollar sign IMU Biosciences Ltd. has closed its series A at £40 million (US$53.9 million), adding £28.5 million to the initial close in January 2024, and bringing the total raised since the company’s formation in 2021 to £45 million. Since that first close, IMU has built what is claimed as the world’s largest high-definition immune system dataset, with almost 25,000 profiles of healthy volunteers and disease-specific patient cohorts. http://www.bioworld.com/articles/731669 Wed, 03 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731669-imus-53m-series-a-to-advance-high-definition-immune-profiling-tech Pound sign on tech background IMU Biosciences Ltd. has closed its series A at £40 million (US$53.9 million), adding £28.5 million to the initial close in January 2024, and bringing the total raised since the company’s formation in 2021 to £45 million. Since that first close, IMU has built what is claimed as the world’s largest high-definition immune system dataset, with almost 25,000 profiles of healthy volunteers and disease-specific patient cohorts. http://www.bioworld.com/articles/731528 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731528-imus-53m-series-a-to-advance-high-definition-immune-profiling-tech Pound sign on tech background Although analysts liked the data – calling them “truly amazing” and “transformational” – Wall Street apparently had qualms about three cancer cases that turned up in phase III top-line data from the Abtect maintenance trial with obefazimod. Paris-based Abivax SA’s oral, first-in-class miRNA-124 enhancer performed well in adults with moderately to severely active ulcerative colitis (UC), but shares of (NASDAQ:ABVX) closed June 2 at $72.50, down 44%, or $57.19. http://www.bioworld.com/articles/731525 Tue, 02 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731525-cancer-specter-looming-abtect-effect-in-uc-wallops-abivax Person holding stomach in pain New data from Grail Inc.’s randomized study of its Galleri multicancer early detection test could not alter the fact that the U.K. trial missed the primary endpoint of reducing the number of cancers diagnosed at stage III and stage IV. But the company is now suggesting that discounting the initial screen, when most late stage cancers were detected, would be more representative of a real-life steady state screening program. http://www.bioworld.com/articles/731515 Mon, 01 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731515-asco-2026-grail-shifts-focus-to-secondary-endpoints-in-uk-study Grail Galleri multicancer early detection test Credit: Grail Inc. Edgewise Therapeutics Inc. is pulling in $1.55 billion up front by selling its muscular dystrophy business, including its fast skeletal myosin inhibitor, sevasemten (EDG-5506), to Servier SA. The deal is potentially worth up to $2.65 billion when including a potential $1.1 billion in milestone payments. http://www.bioworld.com/articles/731512 Mon, 01 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731512-edgewise-sells-muscular-dystrophy-assets-to-servier-for-265b Purple pie chart The much-awaited phase III readout from Oculis Holding AG’s OCS-01 in diabetic macular edema (DME) fell short of expectations, delaying the possibility of a topical eye drop option for DME patients and prompting the company to shuffle its pipeline priorities, with a focus on late-stage programs targeting optic neuropathies and dry eye disease. http://www.bioworld.com/articles/731510 Mon, 01 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731510-oculis-shifts-focus-after-phase-iii-dme-disappointment Woman using eyedrops Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics. http://www.bioworld.com/articles/731648 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731648-trop2-adcs-progress-into-first-line-for-lung-breast-cancers Floating antibody drug conjugates Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics. http://www.bioworld.com/articles/731444 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731444-trop2-adcs-progress-into-first-line-for-lung-breast-cancers Floating antibody drug conjugates Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis. http://www.bioworld.com/articles/731441 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731441-abbott-receives-ce-mark-for-dual-glucose-ketone-sensing-systems Abbott Libre Duo sensor on patient  Libre Duo sensor. Credit: Abbott Laboratories GSK plc has announced a breakthrough in the treatment of chronic hepatitis B, reporting a functional cure rate of 19% across two phase III trials of its antisense oligonucleotide bepirovirsen. http://www.bioworld.com/articles/731439 Thu, 28 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731439-breakthrough-as-gsks-bepirovirsen-clears-19-of-chronic-hep-b-infections Liver with hepatitis viruses, blood cells There are initial signs that President Donald Trump’s most-favored nation (MFN) policy may be further delaying access to new drugs in Europe, as companies hold off commercializing in these countries to avoid lower European prices being referenced in the U.S. http://www.bioworld.com/articles/731421 Wed, 27 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731421-initial-data-hint-that-us-mfn-pricing-is-hitting-access-in-europe Medicine spilling onto map of Europe Acknowledging that the spread of the Andes virus and the resulting disease, hantavirus pulmonary syndrome, “constitutes a credible risk of a future public health emergency,” U.S. Health and Human Services Secretary Robert Kennedy is issuing a declaration to provide liability protection for manufacturers, distributors and providers using favipiravir as a medical countermeasure (MCM) against the virus. http://www.bioworld.com/articles/731406 Tue, 26 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731406-kennedy-offers-emergency-immunity-for-use-of-mcm-in-hantavirus Less than two weeks after the outbreak was officially declared, animal studies of a newly designed vaccine against the Bundibugyo Ebola virus are now underway in the U.S. and U.K., and the Serum Institute of India is standing ready to manufacture the vaccine for clinical trials. If the animal tests are positive, the vaccine will be ready for clinical trials in two to three months. http://www.bioworld.com/articles/731403 Tue, 26 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731403-work-underway-on-vaccines-antivirals-against-rare-bundibugyo-ebola-outbreak Ebola virus in petri dish with lab, scientist background Medtronic plc is strengthening its pain management portfolio with its $650 million move to buy SPR Therapeutics Inc. and bring the company’s peripheral nerve stimulation system for sustained pain relief into its neuromodulation offering. The deal marks Medtronic’s third tuck-in deal so far this year, following its $585 million purchase of Cathworks Ltd. and $550 million acquisition of Scientia Vascular Inc., and is also a sign of the momentum in M&A activity in the medtech sector with other players making strategic acquisitions. http://www.bioworld.com/articles/731402 Tue, 26 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731402-medtronic-bolsters-pain-portfolio-in-650m-spr-therapeutics-buy SPR Therapeutic Inc.’s Sprint PNS system Sprint PNS system. Credit: SPR Therapeutics Inc. As generic versions of its blockbuster drug Ofev (nintedanib) start to hit the market, Boehringer Ingelheim GmbH looks to have swerved the patent cliff, with European and Japanese regulators both approving a potential replacement, Jascayd (nerandomilast), this week. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use also recommended Novartis AG’s Vijoice (alpelisib) be given conditional approval in the treatment of PIK3CA-related overgrowth spectrum disorders. http://www.bioworld.com/articles/731385 Fri, 22 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731385-ema-poised-to-be-4th-regulator-approving-boehringers-jascayd-lung-drug Jascayd Credit: Boehringer Ingelheim GmbH Infex Therapeutics Ltd. has published positive phase IIa data for its lead program, RESP-X, in the treatment of exacerbations of chronic respiratory infections caused by Pseudomonas aeruginosa and is now laying the ground for phase IIb development, after raising £4.3 million (US$5.8 million) in new capital. Pseudomonas aeruginosa and is now laying the ground for phase IIb development, after raising £4.3 million (US$5.8 million) in new capital.]]> http://www.bioworld.com/articles/731376 Thu, 21 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731376-infex-has-positive-phase-iia-data-in-bronchiectasis-preps-for-next-trial Lung infection caused by bacteria Pseudomonas aeruginosa As interests and competition in the intravascular lithotripsy (IVL) market heats up, Shockwave Medical Inc. said it believes that its latest coronary IVL catheter, the C2 Aero, and other projects in the pipeline, will help it to maintain its leadership in calcium modification. http://www.bioworld.com/articles/731372 Thu, 21 May 2026 08:00:00 -0400 https://www.bioworld.com/articles/731372-as-ivl-technologies-advance-shockwave-looks-to-defend-its-lead Shockwave Medical - C2 Aero coronary IVL C2 Aero coronary IVL catheter. Credit: Shockwave Medical Inc. A subgroup analysis of data from Boston Scientific Corp.’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris. http://www.bioworld.com/articles/731344 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731344-subgroup-analysis-of-the-champion-af-trial-shows-age-not-a-factor Boston Scientific Watchman FLX Watchman FLX left atrial appendage closure device. Credit: Boston Scientific Corp. Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women. http://www.bioworld.com/articles/731340 Wed, 20 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731340-all-women-data-show-allegra-edge-in-female-tavr-patients Biosensors International Allegra transcatheter heart valve Allegra transcatheter heart valve. Credit: Biosensors International