https://www.bioworld.com/rss en-us Branded Lipfendra, Merck & Co. Inc.’s oral PCSK9 inhibitor enlicitide, part of the FDA Commissioner’s National Priority Voucher pilot program, won U.S. approval to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. http://www.bioworld.com/articles/732691 Thu, 16 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732691-us-fda-approves-mercks-lipfendra-first-oral-pcsk9-for-ldl-c Lipfendra Credit: Merck & Co. Inc. 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 Pulmonary arterial hypertension (PAH) is a fatal condition characterized by abnormal vascular remodeling from excessive proliferation of pulmonary arterial smooth muscle cells (PASMCs). Recent evidence has suggested that structural maintenance of chromosomes 4 (SMC4) is upregulated in pulmonary tissue from patients with PAH and may be a potential target for therapy, since it has been tied to modulating pathological cell proliferation. http://www.bioworld.com/articles/732679 Thu, 16 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732679-smc4-blockade-ameliorates-preclinical-pulmonary-arterial-hypertension Lungs 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 Drug Farm Biotechnology Co. Ltd. closed a $55 million series D round to advance its AI-developed alpha-protein kinase 1 (ALPK1) inhibitor, DF-003, in a phase III trial for ROSAH syndrome, a rare genetic disease that can lead to blindness. http://www.bioworld.com/articles/732600 Tue, 14 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732600-drug-farm-bags-55m-series-d-to-advance-ai-developed-alpk1-drug Blue dollar sign on white background 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 Wuhan Createrna Science and Technology Co. Ltd. has reported new complement factor D (CFD) inhibitors potentially useful for the treatment of cardiovascular, immunological, eye, genitourinary, renal, respiratory, neurological disorders and hematological diseases. http://www.bioworld.com/articles/732637 Tue, 14 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732637-wuhan-createrna-discloses-new-cfd-inhibitors The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc. http://www.bioworld.com/articles/732529 Fri, 10 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732529-combination-locked-out-in-attr-cm-dead-expert-says Human heart within crosshairs The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services, has announced the teams for the THRIVE (Treating Hereditary Rare diseases with In Vivo prEcision genetic medicines) program. With a commitment of up to $160 million over 5 years, THRIVE aims to accelerate solutions for rare genetic pediatric diseases across multiple technological approaches, clinical trial designs and deployment models. http://www.bioworld.com/articles/732544 Fri, 10 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732544-arpa-h-program-supports-advances-for-rare-genetic-diseases News of the unexpected phase III failure of the gene silencing drug Wainua (eplontersen) in the treatment of transthyretin-mediated amyloid cardiomyopathy sent Astrazeneca plc’s shares (NYSE:AZN) down $10.88 to close July 9 at $178.40. http://www.bioworld.com/articles/732518 Thu, 09 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732518-ionis-az-shares-down-on-unexpected-wainua-flop-in-cardiomyopathy Wainua autoinjector Credit: wainua.com Apolin Bio Ltd. and Shanghai Viva Dancheng Entrepreneurship Incubator Management Ltd. have detailed polycyclic compounds acting as apolipoprotein A (ApoA; LPA)/apolipoprotein B-100 (APOB) interaction inhibitors that are potentially useful for the treatment of cardiovascular disorders. http://www.bioworld.com/articles/732513 Thu, 09 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732513-apolin-bio-and-viva-biotech-present-new-apoa-apob-interaction-inhibitors Alebund Pharmaceuticals (Jiangsu) Ltd. was the third Chinese biotech company to debut in Hong Kong this month, with June IPO proceeds from Alebund, Longbio Pharma Co. Ltd. and Shaanxi Micot Pharmaceutical Technology Co. Ltd. totaling about HK$4.7 billion (US$600 million). http://www.bioworld.com/articles/732473 Tue, 07 Jul 2026 08:00:00 -0400 https://www.bioworld.com/articles/732473-hk-biotech-listings-gain-traction-in-q2-with-trio-of-june-ipos HKEX on phone, digital stock chart Credit: piter2121 - stock.adobe.com FAM3D is a protein mainly expressed in the gastrointestinal tract, but also detectable in vascular endothelial cells. It is known to worsen intestinal inflammation by recruiting neutrophils, but its role in atherosclerosis is not well understood. http://www.bioworld.com/articles/732378 Fri, 03 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732378-targeting-fam3d-as-a-strategy-against-atherosclerosis Human heart within crosshairs Shanghai Zheye Biotechnology LLC has discovered new phenylpropionic acid derivatives acting as apolipoprotein A (ApoA; LPA)/apolipoprotein B-100 (APOB) interaction inhibitors potentially useful for the treatment of stroke, atherosclerosis, thrombosis, coronary heart disease and aortic valve stenosis. http://www.bioworld.com/articles/732345 Wed, 01 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732345-shanghai-zheye-biotechnology-patents-new-apoa-apob-interaction-inhibitors Bayer AG has patented new potassium channel Kir3.4 (GIRK4; KCNJ5) and/or Kir3.1/3.4 (GIRK1/4; KCNJ3/5) blockers potentially useful for the treatment of heart failure, arrhythmia, primary hyperaldosteronism and hypertension. http://www.bioworld.com/articles/732342 Wed, 01 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732342-bayer-discovers-new-potassium-channel-blockers Alebund Pharmaceuticals (Jiangsu) Ltd. was the third Chinese biotech company to debut in Hong Kong this month, with June IPO proceeds from Alebund, Longbio Pharma Co. Ltd. and Shaanxi Micot Pharmaceutical Technology Co. Ltd. totaling about HK$4.7 billion (US$600 million). http://www.bioworld.com/articles/732393 Wed, 01 Jul 2026 08:00:00 -0400 https://www.bioworld.com/articles/732393-hk-biotech-listings-gain-traction-in-q2-with-trio-of-june-ipos HKEX on phone, digital stock chart Credit: piter2121 - stock.adobe.com Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file. http://www.bioworld.com/articles/732227 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732227-ema-reverses-its-stance-on-acadias-rett-syndrome-therapy-daybu EU flags at European Commission building Johnson & Johnson this week launched its dual-energy Thermocool Smarttouch SF platform in Europe bringing another option to physicians looking to enhance their electrophysiology procedures. The system combines radiofrequency (RF) and pulsed field ablation in one device to treat atrial fibrillation, entering what is becoming an increasingly crowded market for cardiac ablation technology. http://www.bioworld.com/articles/732175 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732175-j-and-j-brings-dual-energy-cardiac-ablation-technology-to-europe Johnson & Johnson’s Thermocool Smarttouch SF platform J&J’s Thermocool Smarttouch SF platform. Credit: Johnson & Johnson Fortvita Biologics Inc. and Innovent Biologics (Suzhou) Co. Ltd. have identified new calcitonin receptor (CALCR; CT-R) and amylin receptor dual agonists potentially useful for the treatment of metabolic dysfunction-associated steatohepatitis (MASH; NASH), overweight, dyslipidemia, cognitive and cardiovascular disorders. http://www.bioworld.com/articles/732142 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732142-fortvita-biologics-innovent-biologics-discover-new-calcitonin-and-amylin-receptor-dual-agonists Merck KGaA has entered into a strategic research-stage collaboration with Saturnus Bio, a biotech founded by Versant Ventures, to establish a foundational portfolio in the field of rare genetic cardiomyopathies. http://www.bioworld.com/articles/732137 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732137-merck-kgaa-announces-cardio-partnership-with-saturnus-bio Female hands holding heart on cardiogram 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 Thu, 25 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. Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. is seeking up to HK$1.22 billion (US$155 million) in a Hong Kong IPO to advance its lead phase III chronic kidney disease candidate, MT-1013, and next-generation obesity therapies. http://www.bioworld.com/articles/732154 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732154-chinas-micot-targets-hk12b-ipo-to-advance-metabolic-portfolio IPO, coins, upward arrow Croívalve Ltd. secured a further $20 million in series B financing for its Duo Adapt system, a transcatheter device that treats tricuspid regurgitation. The company also received $7 million from the European Innovation Council and the Disruptive Technologies Innovation Fund in grant financing. Croívalve will use the funds to expand its clinical study, which is evaluating the safety and performance of the Duo Adapt system in patients with severe or greater symptomatic tricuspid regurgitation. http://www.bioworld.com/articles/732061 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732061-croivalve-secures-27m-for-duo-adapt-tricuspid-device Croívalve Duo System The Duo system is a novel transcatheter heart valve designed to preserve the patient’s native anatomy while treating tricuspid regurgitation. Credit: Croívalve Ltd. Europe must focus on prevention and innovation to ensure its health care systems are sustainable in the long term, said Olivér Várhelyi, European commissioner for health and animal welfare. With an aging population, rising chronic diseases, a stretched workforce and geopolitical tensions, the universal health coverage that Europeans enjoy is under threat, he told delegates at the HLTH Europe conference in Amsterdam last week. http://www.bioworld.com/articles/732049 Mon, 22 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732049-europes-health-system-under-threat-prevention-and-innovation-key Female healthcare professional holding health icon Scribe Therapeutics Inc. has been awarded more than $25 million by California Institute for Regenerative Medicine (CIRM) across two preclinical programs for CRISPR-based gene editing therapies targeting cardiovascular and metabolic disease. http://www.bioworld.com/articles/732028 Fri, 19 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732028-scribes-cardiometabolic-programs-gain-cirm-boost Artery and plaque Cardiovascular-focused Kardigan Inc. is the latest biopharma firm to take advantage of the wide open IPO window, pricing an upsized offering of 25 million shares at $16 per share, the high end of its proposed range, to rake in gross proceeds of about $400 million. http://www.bioworld.com/articles/731920 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731920-biopharma-ipos-stay-strong-as-kardigan-prices-upsized-400m-offering Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. is seeking up to HK$1.22 billion (US$155 million) in a Hong Kong IPO to advance its lead phase III chronic kidney disease candidate, MT-1013, and next-generation obesity therapies. http://www.bioworld.com/articles/731909 Wed, 17 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731909-chinas-micot-targets-hk12b-ipo-to-advance-metabolic-portfolio IPO, coins, upward arrow Fresh off a deal with Travere Therapeutics Inc. for civorebrutinib worth more than $1.14 billion, Everest Medicines Ltd. went on a shopping spree, striking three deals in six days to expand its pipeline and geographic reach across Asia Pacific. http://www.bioworld.com/articles/731982 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731982-three-deals-in-six-days-everest-builds-late-stage-apac-portfolio Hands holding gears Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures. http://www.bioworld.com/articles/731889 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731889-edgewise-heads-to-phase-iii-with-solid-edg-7500-data-in-hcm Abstract blue human heart with red cardio pulse line and red circle Chengdu Shibeikang Biological Medicine Technology Co. Ltd. has patented new platelet adhesion inhibitors reported to be useful for the treatment of cardiovascular and cerebrovascular disorders. http://www.bioworld.com/articles/731973 Tue, 16 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/731973-chengdu-shibeikang-synthesizes-new-platelet-adhesion-inhibitors