https://www.bioworld.com/rss en-us About a week after closing its $10.6 billion acquisition of Nuvalent Inc., GSK plc has reaped the first reward, announcing U.S. FDA approval of zidesamtinib in non-small-cell lung cancer (NSCLC). Branded Jideytro, the ROS1 selective inhibitor is indicated for use in adults with locally advanced or metastatic ROS1-positive disease who have received a prior ROS1 kinase inhibitor. http://www.bioworld.com/articles/732912 Wed, 22 Jul 2026 17:11:35 -0400 https://www.bioworld.com/articles/732912-gsks-newly-acquired-jideytro-wins-fda-nod-in-nsclc Lung cancer illustration Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Abelzeta, Intelligent, Kyowa, Mastel, Omeicos, Royal Philips, Seegene. http://www.bioworld.com/articles/732771 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732771-regulatory-actions-for-july-22-2026 Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Akari, Ashlins, Azurity, Eli Lilly, Engitix, Forge Biologics, Fujifilm, Genentech, Hebei Senlang, Kaveri, Jupiter, Lee, Lonza, Lupin, Maxcyte, Myriad, Neurosigma, Novo Nordisk, Pharmala, Polypid, Polypeptide, Restore Vision, Roche, Samsung, Tempest, Vivex, Whitehawk. http://www.bioworld.com/articles/732770 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732770-other-news-to-note-for-july-22-2026 Clinical updates for biopharma and med tech, including data readouts and publications: Agios, Akagera, Alpha Tau Medical, Enterome, Imunon. http://www.bioworld.com/articles/732769 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732769-in-the-clinic-for-july-22-2026 Biopharma and med-tech companies raising money in public or private financings, including: Brenus, Estrigenix, Rege Nephro, TCGX. http://www.bioworld.com/articles/732768 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732768-financings-for-july-22-2026 New hires and promotions in the biopharma and med-tech industries, including: Allogenetics, Altesa, Neuronetics, Phio, Revagenix. http://www.bioworld.com/articles/732767 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732767-appointments-and-advancements-for-july-22-2026 The U.S. FDA granted Johnson & Johnson de novo authorization for its Ottava robotic surgical system, which can now be marketed for multiple surgeries, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy and others. http://www.bioworld.com/articles/732766 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732766-j-and-j-wins-fda-authorization-for-ottava-robotic-surgical-system Ottava robotic surgical system Ottava robotic surgical system. Credit: Johnson & Johnson After languishing on the U.S. Senate floor for more than a year, the Affordable Prescriptions for Patients Act (S. 1041) finally got a unanimous vote July 21 and is now on its way to the House, again. Aimed at reining in patent thickets, the bill limits the number of patents a biologics sponsor can assert against a biosimilar when engaging in the voluntary “patent dance” laid out in the Biologics Price Competition and Innovation Act. The number is no more than 20 patents, a limit the bill’s bipartisan sponsors called “reasonable.” http://www.bioworld.com/articles/732765 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732765-us-senate-greenlights-bill-to-tame-biologic-patent-thickets U.S. Capitol building When it comes to the U.S. biopharma sector tariff, generic drug companies have had a question mark dangling over their tariff-free ride ever since President Donald Trump first started promising, or threatening, the tariff last year. http://www.bioworld.com/articles/732764 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732764-trump-generic-drugs-to-be-subject-to-tariffs-in-2028 White tablets spilling out of white bottle, blue background Science Corp. launched its Prima retinal implant in Europe after receiving CE mark approval under the Medical Device Regulation, a significant milestone for the brain-computer interface (BCI) field. However, unlike most BCIs, which decode neural activity to translate thoughts into actions, Prima writes visual information into the nervous system to restore vision. http://www.bioworld.com/articles/732763 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732763-science-gains-ce-mark-ability-precision-show-bci-capabilities Prima implant The Prima retinal implant. Credit: Science Corp. Wall Street is sifting data to figure out what Celldex Inc.’s phase II failure with KIT inhibitor barzolvolimab (barzo) in prurigo nodularis (PN) might mean for the upcoming phase III readout with the same drug in chronic spontaneous urticaria (CSU). http://www.bioworld.com/articles/732762 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732762-drum-kit-celldex-csu-rhythm-still-on-post-barzo-pn-phase-ii Person scratching arm Once again, Arrowhead Pharmaceuticals Inc.’s Redemplo (plozasiran) is hot on the heels of Ionis Pharmaceuticals Inc.’s Tryngolza (olezarsen). Less than a month after the latter gained U.S. FDA approval for use in severe hypertriglyceridemia (sHTG), Arrowhead reported positive top-line results from its phase III studies in sHTG, with findings described by one analyst as “best-case scenario,” setting the stage for a supplemental NDA filing with the FDA before year-end. http://www.bioworld.com/articles/732761 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732761-arrowhead-rises-on-phase-iii-hypertriglyceridemia-readout Artery, blood cells, triglycerides Kolon Tissuegene Inc.’s TG-C, an allogeneic cell and gene therapy candidate for knee osteoarthritis (OA), missed both co-primary endpoints and all key secondary endpoints in a highly anticipated top-line phase III clinical trial readout. http://www.bioworld.com/articles/732754 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732754-kolon-tissuegene-shares-fall-as-tg-c-misses-knee-oa-endpoints 3D illustration of knee joint While the pace of executive orders (EOs) coming out of the White House continues to decline, the impact of new EOs on U.S. health agencies, life sciences industries and the practice of medicine remains just as disconcerting as a year ago. http://www.bioworld.com/articles/732727 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732727-trump-issuing-fewer-eos-but-still-creating-uncertainty Businessman signing documents Insmed Inc. has delivered further evidence of the advantages of its once-daily pulmonary arterial hypertension (PAH) drug TPIP (treprostinil palmitil inhalation powder), with data from an open-label extension of the phase IIb trial showing patients in the treated arm maintained the benefits over 24 months. http://www.bioworld.com/articles/732724 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732724-open-label-extension-drives-home-benefits-of-insmeds-pah-therapy Lungs A preview of the next edition of BioWorld, July 22, 2026 http://www.bioworld.com/articles/732772 Wed, 22 Jul 2026 11:00:00 -0400 https://www.bioworld.com/articles/732772-arrowhead-rises-on-phase-iii-hypertriglyceridemia-readout BioWorld briefs for July 22, 2026. http://www.bioworld.com/articles/432891 Wed, 22 Jul 2026 11:00:00 -0400 https://www.bioworld.com/articles/432891-todays-news-in-brief Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Acadia, Almirall, Dyne, GSK, Oncolytics Biotech. http://www.bioworld.com/articles/732759 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732759-regulatory-actions-for-july-21-2026 Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: BMS, Halozyme, Incyte, Scholar Rock. http://www.bioworld.com/articles/732758 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732758-other-news-to-note-for-july-21-2026 Clinical updates for biopharma and med tech, including data readouts and publications: 4D, Actinogen, Belite, Harrow, Nuvation, Prolocor, Regenxbio, Samsung Bioepis. http://www.bioworld.com/articles/732757 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732757-in-the-clinic-for-july-21-2026 Biopharma and med-tech companies raising money in public or private financings, including: Latigo, Nuvox, Scribe. http://www.bioworld.com/articles/732756 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732756-financings-for-july-21-2026 New hires and promotions in the biopharma and med-tech industries, including: Billiontoone, Mentari, Monopar, Talawar. http://www.bioworld.com/articles/732755 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732755-appointments-and-advancements-for-july-21-2026 In a rapid-fire voting session, the U.S. House suspended the rules July 20 to pass, by voice vote, a slate of bipartisan health bills ranging from reducing animal testing in drug development to clarifying Medicare coverage of wheelchairs. http://www.bioworld.com/articles/732753 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732753-bipartisan-health-bills-get-passing-vote-in-us-house U.S. flag, stethoscope Axiom Biosciences, rebranded from Cytonus Therapeutics Inc. in June 2026, plans to be one of the first U.S. biotechs to IPO on the main board of The Stock Exchange of Hong Kong. The San Diego-based company is preparing audits as the first step to a potential IPO in 2027. http://www.bioworld.com/articles/732752 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732752-us-based-axiom-plans-hong-kong-listing HKEX exterior Credit: Lewis Tse Pui Lung - stock.adobe.com The decision by Agios Pharmaceuticals Inc. to end work with next-generation oral pyruvate kinase activator tebapivat in sickle cell disease (SCD) put pressure on the company’s first-generation Pyrukynd (mitapivat) and left Novo Nordisk A/S in pole position as the firm advances etavopivat toward an approval bid in the second half of this year. http://www.bioworld.com/articles/732751 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732751-agios-phase-ii-tebapivat-splats-in-scd-pyrukynd-top-of-mind Sickle cell disease 3D illustration Biopharma financing activity through the first two quarters of 2026 totaled $60.14 billion, the strongest first-half (H1) showing since 2024’s $70.32 billion and well above 2025’s $29.53 billion over the same period. The second quarter (Q2) of 2026 was particularly strong at $34.69 billion, the highest single quarter since Q1 2024’s $47.25 billion. Q1 came in at $25.45 billion, more than double 2025’s Q1 figure of $13.12 billion. http://www.bioworld.com/articles/732750 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732750-parabilis-tops-kailera-as-biopharma-ipos-surge-to-best-h1-since-2021 IPO line graph An increase in the level of M&A activity and some sizeable financing rounds are encouraging signs for the med-tech investment environment, said Joey Mason, life sciences venture partner at Claret Capital Partners. He pointed to Medtronic plc’s acquisition of SPR Therapeutics Inc., and Neurent Medical Ltd.’s large fundraise earlier in the year, as evidence of the improving sentiment. http://www.bioworld.com/articles/732749 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732749-med-tech-funding-outlook-improves-as-dealmaking-accelerates Coins and charts Scientists in Europe have added their voices to the many thousands of objections made against proposed changes to the oversight of U.S. federal research grants, under which political appointees and not peer review experts would have the final say on who and what gets funding. The concern is that awarding grants, based on the principle that research proposals must be in keeping with President Donald Trump’s policy priorities, poses a threat to open scientific inquiry and academic freedom, and also will undermine international research collaboration. http://www.bioworld.com/articles/732748 Tue, 21 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732748-europe-voices-concerns-on-changes-to-us-federal-grant-rules Blocks displaying microscopes and money bags A preview of the next edition of BioWorld, July 21, 2026 http://www.bioworld.com/articles/732760 Tue, 21 Jul 2026 11:00:00 -0400 https://www.bioworld.com/articles/732760-europe-voices-concerns-on-changes-to-us-federal-grant-rules Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Abbvie, Allergan Aesthetics, Amneal, Boehringer, Camurus, Novartis, Sichuan, Systimmune, Vanda. http://www.bioworld.com/articles/732746 Mon, 20 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732746-regulatory-actions-for-july-20-2026