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 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. 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 South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics. http://www.bioworld.com/articles/732668 Wed, 22 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732668-korea-targets-generics-innovation-in-drug-pricing-overhaul Generic drugs and bottle 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/732893 Wed, 22 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732893-europe-voices-concerns-on-changes-to-us-federal-grant-rules Blocks displaying microscopes and money bags Pharmability AB has received authorization from the Swedish Medical Products Agency to initiate a phase Ib trial of TIR-C in atopic dermatitis. http://www.bioworld.com/articles/732826 Wed, 22 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732826-pharmabilitys-tir-c-gains-trial-clearance-for-atopic-dermatitis Skin irritation 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 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 Immix Biopharma Inc.’s shares (NASDAQ:IMMX) sank 14% to $8.80 on July 20 after investors learned that a man named Richard Graydon, who served as its chief medical officer, was in fact a 20-year fugitive from Rhode Island for sexual assault charges. http://www.bioworld.com/articles/732739 Mon, 20 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732739-immix-investors-skittish-over-execs-sexual-assault-arrest Rebates on sales of patented drugs in Germany are to increase from 7% to 15.5%, following passage of an act to reduce healthcare spending across the board. There also will be a 9% rebate on patented vaccines, whilst at the same time prices will be frozen until 2030 and price-volume controls will be introduced to restrict the amount spent overall. http://www.bioworld.com/articles/732693 Thu, 16 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732693-industry-hits-back-as-rebate-on-drugs-more-than-doubles-in-germany Map of Europe highlighting Germany with its flag Citing the significant advancements made in lab testing technologies since the Clinical Laboratory Improvement Amendments (CLIA) were enacted nearly 40 years ago, the U.S. CDC and Center for Medicare and Medicaid Services are considering updating the regulations to reflect today’s technology. http://www.bioworld.com/articles/732536 Thu, 16 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732536-clia-regs-may-be-in-for-an-update Two med-tech companies agreed to settlements with the U.S. government to resolve False Claims Act (FCA) allegations that they submitted Medicare claims for medically unnecessary testing and devices. http://www.bioworld.com/articles/732535 Thu, 16 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732535-labcorp-tactile-systems-resolve-fca-allegations Fosun Pharma subsidiary Fosun Pharmaceutical Industrial Development (Shenzhen) Co. Ltd. has received approval from China’s National Medical Products Administration (NMPA) to commence clinical trials for FXR-0906 for the treatment of hypertriglyceridemia. http://www.bioworld.com/articles/732676 Thu, 16 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732676-fosun-cleared-to-conduct-clinical-trials-with-fxr-0906 Illustration of lipids in the bloodstream There have been plenty of complaints about U.S. Health and Human Services Secretary Robert Kennedy interfering with science. Now he’s facing allegations of a different kind of interference. Sen. Ron Wyden, D-Ore., the ranking member of the Senate Finance Committee, asked the U.S. Office of Special Counsel to immediately open an investigation into election interference claims against the secretary. http://www.bioworld.com/articles/732613 Wed, 15 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732613-senator-calls-for-investigation-of-kennedys-election-interference In an effort to drive down out-of-pocket costs for Americans, the U.S. FTC is resolving an antitrust case through a proposed second settlement with a large pharmacy benefit manager (PBM) and its affiliates. http://www.bioworld.com/articles/732612 Wed, 15 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732612-ftc-settling-case-against-cvs-pbm U.S. Health and Human Services Secretary Robert Kennedy was the 800-pound gorilla that couldn’t be ignored as the Senate Health, Education, Labor and Pensions Committee held a joint confirmation hearing July 15 for President Donald Trump’s nominees for CDC director and the head of the Administration for Strategic Preparedness and Response. http://www.bioworld.com/articles/732609 Wed, 15 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732609-cdc-nominees-qualifications-shadowed-by-kennedy-agenda Erica Schwartz, CDC director nominee Erica Schwartz, nominee for CDC director, speaks at the Senate Health, Education, Labor and Pensions Committee joint confirmation hearing held July 15. Credit: help.senate.gov Atrium Therapeutics Inc. has obtained IND clearance from the FDA for ATR-1072 for the treatment of protein kinase AMP-activated non-catalytic subunit γ2 (PRKAG2) syndrome. http://www.bioworld.com/articles/732647 Wed, 15 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732647-atriums-atr-1072-gains-ind-clearance-for-prkag2-syndrome Illustration of heart analysis for DNA and drug impacts The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection. http://www.bioworld.com/articles/732666 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732666-hlb-hengrui-receive-third-us-fda-rejection-on-liver-cancer-combo Liver tumor treatment conceptual illustration The U.S. Court of Appeals for the Seventh Circuit revived Teva Pharmaceuticals USA Inc.’s breach-of-contract suit against Eli Lilly and Co. July 13, as it chided the lower court for dismissing the complaint at the pleadings stage. http://www.bioworld.com/articles/732601 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732601-tevas-beef-with-lilly-over-forteo-settlement-lives-again More than 52,000 individuals, lawmakers, institutions and other organizations have submitted comments on the White House Office of Management and Budget’s (OMB) proposal to revise its Guidance for Federal Financial Assistance, which serves as a government-wide framework for administering grants, cooperative agreements and other forms of assistance. http://www.bioworld.com/articles/732599 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732599-omb-flooded-with-comments-on-proposed-rule-impacting-grants Speech bubbles Newronika SpA received CE mark certification for its latest adaptive deep brain stimulation (aDBS) system, which includes the integration of Webbiobank, its proprietary cloud-based neural data platform. http://www.bioworld.com/articles/732597 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732597-newronika-gains-ce-mark-for-adaptive-dbs-system-with-webbiobank Newronika aDBS system Newronika's adaptive deep brain stimulation system. Credit: Newronika SpA Edwards Lifesciences Corp. and Genesis Medtech Group Ltd. will pay a total of $12 million in penalties as part of a U.S. FTC settlement resolving allegations that they intentionally structured a deal in which Edwards acquired Genesis’ JC Medical to avoid complying with the notification and waiting period requirements of the Hart-Scott-Rodino Act. http://www.bioworld.com/articles/732531 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732531-med-tech-companies-slapped-with-historic-ftc-penalty Niagen Bioscience Inc.’s proprietary lead small-molecule drug candidate, NB-4168, has been awarded European orphan drug designation and U.S. rare pediatric disease designation for the treatment of ataxia telangiectasia. http://www.bioworld.com/articles/732626 Tue, 14 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732626-niagens-nb-4168-designated-orphan-drug-in-eu DNA illustration The U.S. FDA is proposing a rule to streamline its drug establishment registration regulations for distributed biopharma manufacturing facilities and to strengthen the country’s drug supply chain. http://www.bioworld.com/articles/732587 Mon, 13 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732587-fda-advances-streamlined-rx-registration-path South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics. http://www.bioworld.com/articles/732585 Mon, 13 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732585-korea-targets-generics-innovation-in-drug-pricing-overhaul Generic drugs and bottle A federal jury was wrong when it determined that Astrazeneca plc should pay Wyeth, a Pfizer Inc. unit, $107.5 million in damages for infringing two cancer patents, the U.S. Court of Appeals for the Federal Circuit said in a recent precedential decision. http://www.bioworld.com/articles/732584 Mon, 13 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732584-fed-circuit-once-again-instructs-on-enablement-of-rx-claims Zeta Surgical Inc. received U.S. FDA 510(k) clearance for its transcranial magnetic stimulation (TMS) robotic system which is designed to support precise and repeatable TMS therapy for patients with treatment-resistant depression. http://www.bioworld.com/articles/732582 Mon, 13 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732582-zeta-secures-fda-clearance-for-tms-robotic-system Zeta Surgical TMS robotic system Zeta Surgical's TMS robotic system. Credit: Zeta Surgical Inc.