https://www.bioworld.com/rss en-us 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 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 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732668-korea-targets-generics-innovation-in-drug-pricing-overhaul Generic drugs and bottle 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. SL Science Holding Ltd. has submitted an orphan drug designation request to the FDA for its γδ T-cell therapy product, Vδ2+ γδ T cells, for the treatment of glioblastoma multiforme. http://www.bioworld.com/articles/732565 Mon, 13 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732565-sl-science-seeks-us-orphan-drug-designation-for-t-cell-therapy Illustration of T cells attacking tumor The U.S. SEC reached a settlement with Weiguo Zhai resolving insider trading charges related to Astrazeneca plc’s $1.1 billion acquisition of Icosavax Inc. in 2023. http://www.bioworld.com/articles/732534 Fri, 10 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732534-former-astrazeneca-employee-settles-insider-trading-charges Alongside its duties in evaluating safety and effectiveness of drugs and their postmarketing monitoring, the U.K. Medicines and Healthcare products Agency (MHRA) has now been handed a further brief to support economic growth. http://www.bioworld.com/articles/732533 Fri, 10 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732533-mhra-adds-economic-growth-to-its-drug-and-device-regulation-remit Economic growth illustration with coins, charts 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/732532 Fri, 10 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732532-hlb-hengrui-receive-third-us-fda-rejection-on-liver-cancer-combo Liver tumor treatment conceptual illustration Fate Therapeutics Inc. has obtained IND clearance from the FDA for FT-839, the company’s next-generation, off-the-shelf CAR T-cell product candidate targeting CD19 and CD38 for autoimmune diseases. http://www.bioworld.com/articles/732546 Fri, 10 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732546-fate-therapeutics-ft-839-gains-ind-clearance Illustration of CAR T cells What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services’ (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine, given HHS Secretary Robert Kennedy’s stance on vaccines and several commonly used drugs. http://www.bioworld.com/articles/732516 Thu, 09 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732516-covid-19-injuries-posting-of-crls-on-hhs-2027-rulemaking-agenda US flag and HHS logo Credit: mehaniq41 Urogen Pharma Ltd. has obtained IND approval from the FDA for UGN-501, a next-generation investigational oncolytic virus. A phase I study evaluating intravesical administration of UGN-501 in patients with non-muscle invasive bladder cancer (NMIBC) is expected to begin in the fourth quarter. http://www.bioworld.com/articles/732499 Thu, 09 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732499-urogens-ugn-501-gains-ind-clearance-for-bladder-cancer Art concept for bladder Of all the U.S. SEC’s recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of external affairs at Massbio, told BioWorld. BioWorld.]]> http://www.bioworld.com/articles/732433 Wed, 08 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732433-sec-reform-good-for-life-sciences-startups-but-getting-pushback Gears with regulatory words