https://www.bioworld.com/rss en-us The U.S. FDA’s new Precheck Pilot Program is taking flight with seven biopharma companies on board. As part of the Trump administration’s efforts to encourage onshoring of biopharma manufacturing, the program is intended to increase regulatory predictability, facilitate the construction of U.S. manufacturing sites and streamline the FDA’s plant assessments in advance of a specific product application. http://www.bioworld.com/articles/732244 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732244-fda-clears-first-flight-of-precheck-rx-manufacturing-pilot The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded. The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.]]> http://www.bioworld.com/articles/732242 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732242-nejm-paper-on-tavneos-pivotal-trial-retracted-by-academic-authors Photo of pen and marker on science journal article With the U.S. FDA go-ahead granted June 26 for Viridian Therapeutics Inc.’s IGF-1R antagonist Lumvoa (veligrotug-vvze, or “veli”) as a new thyroid eye disease (TED) therapy – due to launch immediately, the company said – Wall Street will be watching near-term payer dynamics. The drug is set to take on similarly targeted Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved in January 2020 to treat TED. http://www.bioworld.com/articles/732231 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732231-new-viridian-meridian-hopes-veli-high-in-ted-post-fda-win Illustration of a road with three destination markers While the U.S. Supreme Court made it clear earlier this month in Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts. Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts.]]> http://www.bioworld.com/articles/732229 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732229-the-court-said-what-it-said-dc-circuit-tells-norwich Judge's gavel with US flag 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 Viridian Therapeutics Inc.’s U.S. FDA clearance of Lumvoa (veligrotug-vvze) to treat thyroid eye disease (TED) includes labeling for chronic as well as active forms, and fewer infusions – plus fast, durable effects – should give the IGF-1R antagonist leverage in competing with similarly targeted TED drug Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved in January 2020. http://www.bioworld.com/articles/732326 Sun, 28 Jun 2026 00:00:00 -0400 https://www.bioworld.com/articles/732326-fda-says-yes-to-viridians-lumvoa-in-ted Close up of man's eye The EMA is recommending withdrawing Amgen Inc.’s complement inhibitor Tavneos (avacopan) from the market in Europe, saying data provided at the time it assessed the MAA “were found to be incorrect and misleading and could no longer be relied upon for demonstrating Tavneos’ effectiveness.” http://www.bioworld.com/articles/732171 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732171-ema-to-pull-amgens-tavneos-over-incorrect-and-misleading-data Tavneos Credit: Amgen Inc. As expected, and following impressive phase III data released last September, Ionis Pharmaceuticals Inc. won U.S. FDA approval of Tryngolza (olezarsen) for adults with severe hypertriglyceridemia, unlocking a larger indication and one that held both priority review and breakthrough therapy designations. http://www.bioworld.com/articles/732162 Fri, 26 Jun 2026 08:00:00 -0400 https://www.bioworld.com/articles/732162-ionis-wins-wider-tryngolza-approval-for-hypertriglyceridemia Tryngolza pen and packaging Credit: Ionis Pharmaceuticals Inc. For the second time this year, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) canceled a scheduled meeting due to a federal judge’s stay that keeps the panel from meeting with its current membership. Typically, ACIP meets three times a year – in February, June and October. The 2026 June meeting was slated for June 23-25. Whether the adcom meets in October will be up to the courts and how far Health and Human Services Secretary Robert Kennedy digs in his heels to maintain a hand-picked committee tilted toward his view of vaccines. http://www.bioworld.com/articles/732159 Thu, 25 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732159-uncertainty-reigns-as-acip-remains-on-court-hold Empty meeting room The eighth version of the Prescription Drug User Fee Act (PDUFA) is up for renewal next year, but the bulk of the negotiations between the drug development industry and the U.S. FDA is largely complete. At the BIO International Convention, representatives from the industry and trade organization provided an overview of what was agreed upon during the 127 negotiating sessions that were needed to arrive at the commitment letter, which will be sent to Congress later in 2026. http://www.bioworld.com/articles/732158 Thu, 25 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732158-bio-2026-industry-negotiators-preview-pdufa-viii FDA logo on textured paper Credit: Araki Illustrations - stock.adobe.com Nippon Shinyaku Co. Ltd.’s NS-035 has been awarded Japanese orphan drug designation for the treatment of Fukuyama congenital muscular dystrophy. http://www.bioworld.com/articles/732135 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732135-nippon-shinyakus-ns-035-designated-orphan-drug-in-japan 3d illustration of human body muscle tissue anatomy Ascletis Pharma Inc. has received IND clearance from the FDA for ASC-35, a once-monthly subcutaneously administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, for the treatment of obesity. http://www.bioworld.com/articles/732131 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732131-fda-clears-ind-for-ascletis-pharmas-asc-35-for-obesity Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson’s disease. IND approval was also gained in China earlier this month, enabling concurrent clinical development in both China and the U.S. http://www.bioworld.com/articles/732129 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732129-unixells-ux-da003-cleared-for-clinic-in-us-and-china Stem cells When it comes to vaccines and preparedness, platform delivery technologies can be both a boon and a barrier. On the one hand, an existing platform can speed development of a vaccine targeting an unexpected viral scare such as the recent Bundibugyo Ebola and Andes hantavirus outbreaks. On the other hand, the intellectual property (IP) protecting that platform adds to the economic hurdles facing smaller vaccine developers, Douglas Bucklin, a life sciences patent attorney with Volpe Koenig, told BioWorld. BioWorld.]]> http://www.bioworld.com/articles/732079 Wed, 24 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732079-platform-technology-ip-adds-to-vaccine-challenge Virtual IP display The U.S. FDA approved 24 drugs in May 2026, the busiest month of the year so far. Up from April’s 14, it brings the year-to-date total to 84 approvals. Through May, the agency has cleared 20 new molecular entities, a pace that, if sustained, would put 2026 on track to approach or exceed several recent years. http://www.bioworld.com/articles/732067 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732067-us-fda-approves-24-drugs-in-may-in-busiest-month-of-2026 Xocova blister pack Credit: Shionogi & Co. Ltd. With increasing competition from China and other countries, the U.S. Department of Health and Human Services is rolling out Operation Trailblazer, a department-wide strategy to once again make the U.S. the go-to destination for early stage drug development. http://www.bioworld.com/articles/732065 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732065-fda-looks-to-pilot-speedier-early-stage-rx-development FDA headquarters signage Credit: Tada Images - stock.adobe.com China’s National Medical Products Administration approved Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T was approved for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy. http://www.bioworld.com/articles/732064 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732064-china-approves-first-car-t-for-solid-tumors AI-generated illustration of CAR T cells 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 Anhorn Medicines Co. Ltd. has obtained IND clearance from the FDA for its lead neuroprotective candidate, AH-008, for the prevention of chemotherapy-induced peripheral neuropathy. http://www.bioworld.com/articles/732111 Tue, 23 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732111-anhorn-medicines-gains-ind-clearance-for-neuroprotectant-ah-008 Art concept for pain Although shot down last year by the U.S. Court of Appeals for the Ninth Circuit, a constitutional challenge to a state law requiring biopharma companies to disclose trade secrets could live to see another court battle. http://www.bioworld.com/articles/732048 Mon, 22 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732048-scotus-considers-phrma-challenge-to-trade-secret-disclosures Gavel and scales Prime Medicine Inc. has obtained clearance from the New Zealand authority, Medsafe, for the company’s clinical trial application for PM-577a, an investigational Prime Editor for Wilson’s disease. http://www.bioworld.com/articles/732030 Fri, 19 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732030-prime-medicines-pm-577a-cleared-for-clinic-for-wilsons-disease Missing puzzle piece and broken DNA chain Four years after the U.S. FDA issued a complete response letter for Spero Therapeutics Inc.’s oral antibiotic, tebipenem pivoxil hydrobromide, to treat complicated urinary tract infections (cUTI), including pyelonephritis, the agency approved the drug based on phase III data showing noninferiority to intravenous imipenem-cilastatin. http://www.bioworld.com/articles/731919 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731919-gsk-speros-oral-antibiotic-utebzi-for-cuti-wins-us-fda-nod FDA Approved stamp with pills The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously in favor of Moderna Inc.’s trivalent mRNA flu vaccine, mRNA-1010, which the company wants to brand as Mflusiva. On the question of whether the benefits of the product outweigh the risks in people ages 50 to 64, balloting was 9-0, and on whether the same is true in those 65 and older, the tally was again 9-0. http://www.bioworld.com/articles/731917 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731917-table-turned-modernas-high-fi-flu-shot-plays-well-at-adcom Elderly person receiving shot Cenna Biosciences Inc. has obtained IND clearance from the FDA for 8M2D, a first-in-class peptide for the treatment of Alzheimer’s disease. A phase Ia/Ib trial of 8M2D in healthy volunteers and patients with early Alzheimer’s disease is expected to begin dosing late this year. http://www.bioworld.com/articles/732011 Thu, 18 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732011-fda-clears-ind-for-cennas-8m2d-for-alzheimers-disease Beam Therapeutics Inc. has obtained IND clearance from the FDA for BEAM-304 for the treatment of phenylketonuria (PKU). BEAM-304 is a liver-targeting lipid-nanoparticle (LNP) formulation of base editing reagents designed to correct mutations in the phenylalanine hydroxylase (PAH) gene that cause PKU. http://www.bioworld.com/articles/732008 Thu, 18 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732008-beam-therapeutics-beam-304-gains-ind-clearance-for-pku In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies, if not all, will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration. http://www.bioworld.com/articles/731904 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731904-rx-tariff-just-around-the-corner Prescription bottle with dollar sign shadow Another day, another about-face by the U.S. FDA on Uniqure NV’s Huntington’s disease gene therapy. But this latest shift brings good news for the company’s AMT-130, for which the FDA says three-year analysis data from the phase I/II study will be acceptable for an accelerated BLA filing, now expected to be submitted in the third quarter. http://www.bioworld.com/articles/731903 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731903-flexibility-restored-uniqure-plans-for-bla-filing-in-huntingtons Genetic mutation illustration Calidi Biotherapeutics Inc. has received pre-IND regulatory feedback from the FDA on Calidi’s IND-enabling preclinical plans and clinical strategy for CLD-401. The parties agreed on key aspects of the CMC and nonclinical programs, as well as the overall design for the proposed first-in-human study. http://www.bioworld.com/articles/731994 Wed, 17 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731994-calidi-receives-pre-ind-feedback-from-fda-on-cld-401 Oncolytic virus concept illustration On the eve of the June 17 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, which will discuss Moderna Inc.’s mRNA-1010, researchers at Washington University School of Medicine in St. Louis have reported that the vaccine conferred broader and more durable protection than a standard flu shot. http://www.bioworld.com/articles/731989 Wed, 17 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731989-mrna-flu-vaccine-can-activate-broad-germinal-center-response mRNA vaccines are composed of messenger RNA encapsulated in lipid nanoparticles The EMA’s 2025 annual report highlights the pressure it is under to streamline and simplify assessment processes, and the expanded – and explicit – role the agency now has in boosting the competitive position of the EU in the development and manufacturing of drugs. http://www.bioworld.com/articles/731891 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731891-2025-annual-report-reflects-the-changing-role-of-ema EMA report cover