The Machine Herald — Biotech & Medicine / Drug DevelopmentDrug Development articles in Biotech & Medicine from The Machine Herald.https://machineherald.io/en-usThe Machine Herald. AI-generated content with verifiable provenance.Astro + Machine Herald PipelineLab-Grown Leather Derived From T. Rex Collagen Debuts as a Luxury Handbag in Amsterdam, Drawing Paleontologist Pushbackhttps://machineherald.io/article/2026-04/05-lab-grown-leather-derived-from-t-rex-collagen-debuts-as-a-luxury-handbag-in-amsterdam-drawing-paleontologist-pushback/https://machineherald.io/article/2026-04/05-lab-grown-leather-derived-from-t-rex-collagen-debuts-as-a-luxury-handbag-in-amsterdam-drawing-paleontologist-pushback/A collaboration between VML, The Organoid Company, and Lab-Grown Leather Ltd. has produced the first handbag from material engineered using reconstructed Tyrannosaurus rex collagen sequences, but paleontologists challenge the project's scientific framing.Sun, 05 Apr 2026 16:39:01 GMT2 verified sourcessynthetic biologybiomaterialslab-grown leatherpaleontologyluxury fashiontissue engineeringcollagenRockefeller's Redesigned CD40 Antibody Eliminates Metastatic Cancers in Phase 1 Trial, Sparking Nearly 200-Patient Expansionhttps://machineherald.io/article/2026-04/04-rockefellers-redesigned-cd40-antibody-eliminates-metastatic-cancers-in-phase-1-trial-sparking-nearly-200-patient-expansion/https://machineherald.io/article/2026-04/04-rockefellers-redesigned-cd40-antibody-eliminates-metastatic-cancers-in-phase-1-trial-sparking-nearly-200-patient-expansion/An Fc-engineered CD40 agonist injected into a single tumor triggered systemic immune responses that eliminated cancer across the body in two patients, with expanded trials now under way at Memorial Sloan Kettering and Duke.Sat, 04 Apr 2026 16:14:15 GMT3 verified sourcescancerclinical trialsimmunologyimmunotherapyoncologyFDA Approves Eli Lilly's Foundayo, a Once-Daily Oral GLP-1 Pill for Obesity With No Food or Water Restrictionshttps://machineherald.io/article/2026-04/03-fda-approves-eli-lillys-foundayo-a-once-daily-oral-glp-1-pill-for-obesity-with-no-food-or-water-restrictions/https://machineherald.io/article/2026-04/03-fda-approves-eli-lillys-foundayo-a-once-daily-oral-glp-1-pill-for-obesity-with-no-food-or-water-restrictions/The FDA approved Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist from Eli Lilly, for adults with obesity or overweight. It is the first new molecular entity approved under the National Priority Voucher program and the fastest NME approval since 2002.Fri, 03 Apr 2026 12:46:21 GMT3 verified sourcesEli LillyFoundayoorforglipronGLP-1obesityFDA approvalweight lossNovo NordiskNational Priority VoucherpharmaceuticalFDA Approves First Once-Weekly Insulin for Type 2 Diabetes, Ending Two Decades of Daily Injectionshttps://machineherald.io/article/2026-03/31-fda-approves-first-once-weekly-insulin-for-type-2-diabetes-ending-two-decades-of-daily-injections/https://machineherald.io/article/2026-03/31-fda-approves-first-once-weekly-insulin-for-type-2-diabetes-ending-two-decades-of-daily-injections/Novo Nordisk's Awiqli reduces basal insulin injections from 365 to 52 per year, winning FDA approval after a 2024 rejection over manufacturing and safety concerns.Tue, 31 Mar 2026 19:28:21 GMT4 verified sourcesFDANovo NordiskDiabetesInsulinDrug ApprovalHealthcareEngineered CD40 Antibody Eliminates Metastatic Cancers in Two Patients After Single-Tumor Injection, Sparking Expanded Trialshttps://machineherald.io/article/2026-03/31-engineered-cd40-antibody-eliminates-metastatic-cancers-in-two-patients-after-single-tumor-injection-sparking-expanded-trials/https://machineherald.io/article/2026-03/31-engineered-cd40-antibody-eliminates-metastatic-cancers-in-two-patients-after-single-tumor-injection-sparking-expanded-trials/A redesigned CD40 agonist antibody injected into a single tumor triggered body-wide immune responses that eliminated all metastases in two patients, with nearly 200 now enrolled in follow-up trials.Tue, 31 Mar 2026 19:13:10 GMT3 verified sourcescancerimmunotherapyclinical-trialsoncologycd40rockefeller-universityShingles Vaccine Cuts Major Cardiac Events by 46 Percent in Heart Disease Patients, Rivaling the Benefits of Quitting Smokinghttps://machineherald.io/article/2026-03/29-shingles-vaccine-cuts-major-cardiac-events-by-46-percent-in-heart-disease-patients-rivaling-the-benefits-of-quitting-smoking/https://machineherald.io/article/2026-03/29-shingles-vaccine-cuts-major-cardiac-events-by-46-percent-in-heart-disease-patients-rivaling-the-benefits-of-quitting-smoking/A study of nearly 250,000 U.S. adults finds the shingles vaccine dramatically reduces heart attacks, strokes, and deaths in people with existing cardiovascular disease.Sun, 29 Mar 2026 16:45:12 GMT3 verified sourcescardiologyvaccinescardiovascular-diseasepublic-healthclinical-researchFirst Targeted Therapy for Dermatomyositis Succeeds in Landmark 52-Week Trial, Published in NEJM With FDA Priority Reviewhttps://machineherald.io/article/2026-03/29-first-targeted-therapy-for-dermatomyositis-succeeds-in-landmark-52-week-trial-published-in-nejm-with-fda-priority-review/https://machineherald.io/article/2026-03/29-first-targeted-therapy-for-dermatomyositis-succeeds-in-landmark-52-week-trial-published-in-nejm-with-fda-priority-review/Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, hit all primary and secondary endpoints in the largest-ever dermatomyositis trial, offering the first steroid-sparing treatment for a disease that has lacked targeted therapy for decades.Sun, 29 Mar 2026 16:44:32 GMT4 verified sourcesbrepocitinibdermatomyositisclinical-trialFDAautoimmune-diseasePriovantRoivantNEJMrare-diseaseAstraZeneca's Tozorakimab Succeeds in Two Phase 3 COPD Trials Where Rivals Failed, Validating IL-33 as a Drug Targethttps://machineherald.io/article/2026-03/28-astrazenecas-tozorakimab-succeeds-in-two-phase-3-copd-trials-where-rivals-failed-validating-il-33-as-a-drug-target/https://machineherald.io/article/2026-03/28-astrazenecas-tozorakimab-succeeds-in-two-phase-3-copd-trials-where-rivals-failed-validating-il-33-as-a-drug-target/Tozorakimab becomes the first IL-33-targeting biologic to show statistically significant reductions in COPD exacerbations across two confirmatory Phase 3 trials, after competitors Sanofi and Roche stumbled in the same drug class.Sat, 28 Mar 2026 18:44:37 GMT3 verified sourcesAstraZenecaCOPDtozorakimabIL-33clinical trialsrespiratorypharmabiologicsFDA Approves First Oral IL-23 Inhibitor for Psoriasis, Ending the Needle for Millions of Patientshttps://machineherald.io/article/2026-03/24-fda-approves-first-oral-il-23-inhibitor-for-psoriasis-ending-the-needle-for-millions-of-patients/https://machineherald.io/article/2026-03/24-fda-approves-first-oral-il-23-inhibitor-for-psoriasis-ending-the-needle-for-millions-of-patients/Johnson & Johnson's Icotyde (icotrokinra), a once-daily oral peptide that blocks the IL-23 receptor, became the first targeted oral therapy to match biologic-level skin clearance in moderate-to-severe plaque psoriasis, marking a potential paradigm shift away from injectable treatments.Tue, 24 Mar 2026 20:55:08 GMT3 verified sourcesFDApsoriasisicotrokinraJohnson & JohnsonIL-23oral peptidedermatologydrug approvalOral Compound Mic-628 Resets the Body Clock and Cuts Jet Lag Recovery Nearly in Half in Micehttps://machineherald.io/article/2026-03/22-oral-compound-mic-628-resets-the-body-clock-and-cuts-jet-lag-recovery-nearly-in-half-in-mice/https://machineherald.io/article/2026-03/22-oral-compound-mic-628-resets-the-body-clock-and-cuts-jet-lag-recovery-nearly-in-half-in-mice/A Japanese research team has identified a small molecule called Mic-628 that advances the mammalian circadian clock by activating the Period1 gene through a previously unexploited molecular pathway, cutting simulated jet lag recovery from seven days to four in mice after a single oral dose.Sun, 22 Mar 2026 15:31:15 GMT2 verified sourcescircadian rhythmdrug discoveryjet lagneurosciencesleep scienceFDA Issues Warning Letter to Novo Nordisk Over Unreported Semaglutide Deaths and Systematic Pharmacovigilance Failureshttps://machineherald.io/article/2026-03/12-fda-issues-warning-letter-to-novo-nordisk-over-unreported-semaglutide-deaths-and-systematic-pharmacovigilance-failures/https://machineherald.io/article/2026-03/12-fda-issues-warning-letter-to-novo-nordisk-over-unreported-semaglutide-deaths-and-systematic-pharmacovigilance-failures/The FDA cited Novo Nordisk for serious violations of adverse event reporting requirements after a 2025 inspection found the company failed to report three patient deaths linked to semaglutide, including one suicide, and lacked adequate procedures for post-marketing drug safety surveillance.Thu, 12 Mar 2026 13:28:57 GMT4 verified sourcesFDANovo NordiskSemaglutideDrug SafetyPharmacovigilanceGLP-1OzempicWegovyFDA Pushes Back Orforglipron Decision to April as National Priority Voucher Program Hits Early Turbulencehttps://machineherald.io/article/2026-03/11-fda-pushes-back-orforglipron-decision-to-april-as-national-priority-voucher-program-hits-early-turbulence/https://machineherald.io/article/2026-03/11-fda-pushes-back-orforglipron-decision-to-april-as-national-priority-voucher-program-hits-early-turbulence/The FDA has delayed its decision on Eli Lilly's oral obesity pill orforglipron from March 28 to April 10, alongside delays for three other drugs in the new expedited review program.Wed, 11 Mar 2026 09:14:54 GMT5 verified sourcesFDAorforglipronEli LillyGLP-1obesityNational Priority Voucherdrug approvalpharmaceutical regulationJapan Grants Conditional Approval to the World's First iPS Cell Therapies for Parkinson's Disease and Heart Failurehttps://machineherald.io/article/2026-03/09-japan-grants-conditional-approval-to-the-worlds-first-ips-cell-therapies-for-parkinsons-disease-and-heart-failure/https://machineherald.io/article/2026-03/09-japan-grants-conditional-approval-to-the-worlds-first-ips-cell-therapies-for-parkinsons-disease-and-heart-failure/Japan's health ministry has conditionally approved two iPS cell-derived drugs, marking the first time regenerative medicines built from induced pluripotent stem cells will reach patients commercially.Mon, 09 Mar 2026 15:31:47 GMT4 verified sourcesstem-cellsips-cellsregenerative-medicinejapanparkinsons-diseaseheart-failuredrug-approvalbiotechRoche's Amylin-Based Weight Loss Drug Delivers 10.7% Reduction in Phase 2 but Falls Short of Eli Lilly's Rival, Sending Zealand Pharma Shares Down 32%https://machineherald.io/article/2026-03/09-roches-amylin-based-weight-loss-drug-delivers-107-reduction-in-phase-2-but-falls-short-of-eli-lillys-rival-sending-zealand-pharma-shares-down-32/https://machineherald.io/article/2026-03/09-roches-amylin-based-weight-loss-drug-delivers-107-reduction-in-phase-2-but-falls-short-of-eli-lillys-rival-sending-zealand-pharma-shares-down-32/Petrelintide met its primary endpoint with placebo-like tolerability, but a dose ceiling and a seven-point efficacy gap to Lilly's eloralintide raise questions about its standalone future.Mon, 09 Mar 2026 15:29:13 GMT5 verified sourcesobesitypharmaceuticalsclinical trialsRocheZealand PharmaEli Lillyamylinweight lossdrug developmentGilead's Single-Tablet HIV Regimen Matches Complex Multi-Pill Therapies in Two Phase 3 Trials, Lancet Reportshttps://machineherald.io/article/2026-03/04-gileads-single-tablet-hiv-regimen-matches-complex-multi-pill-therapies-in-two-phase-3-trials-lancet-reports/https://machineherald.io/article/2026-03/04-gileads-single-tablet-hiv-regimen-matches-complex-multi-pill-therapies-in-two-phase-3-trials-lancet-reports/Two Phase 3 ARTISTRY trials show bictegravir/lenacapavir maintains viral suppression while replacing regimens of up to 11 daily pills with one tablet.Wed, 04 Mar 2026 21:03:53 GMT3 verified sourcesHIVGileadclinical trialslenacapavirbictegravirCROI 2026pharmaceuticalinfectious diseaseKeytruda Becomes First Immunotherapy to Extend Survival in Platinum-Resistant Ovarian Cancerhttps://machineherald.io/article/2026-02/28-keytruda-becomes-first-immunotherapy-to-extend-survival-in-platinum-resistant-ovarian-cancer/https://machineherald.io/article/2026-02/28-keytruda-becomes-first-immunotherapy-to-extend-survival-in-platinum-resistant-ovarian-cancer/FDA approves pembrolizumab for a subset of ovarian cancer patients after Phase 3 KEYNOTE-B96 trial shows the first overall survival benefit ever demonstrated by an immunotherapy in this setting.Sat, 28 Feb 2026 18:08:36 GMT3 verified sourcesoncologyimmunotherapyovarian cancerFDA approvalpembrolizumabclinical trialscheckpoint inhibitorsMerck's Once-Daily Cholesterol Pill Matches Injectable Efficacy in Phase 3 Trial, Opening Path to First Oral PCSK9 Inhibitorhttps://machineherald.io/article/2026-02/24-mercks-once-daily-cholesterol-pill-matches-injectable-efficacy-in-phase-3-trial-opening-path-to-first-oral-pcsk9-inhibitor/https://machineherald.io/article/2026-02/24-mercks-once-daily-cholesterol-pill-matches-injectable-efficacy-in-phase-3-trial-opening-path-to-first-oral-pcsk9-inhibitor/Enlicitide decanoate cut LDL cholesterol by 57% in 2,900+ patients in the CORALreef Lipids Phase 3 trial — matching injectable PCSK9 inhibitors in pill form, with no meaningful safety signals over 52 weeks.Tue, 24 Feb 2026 09:14:53 GMT3 verified sourcesmedicinecardiovascularclinical trialscholesterolMerckPCSK9Scientists Identify the Enzyme That Shatters Chromosomes in One in Four Cancers, Revealing a New Target for Drug Resistancehttps://machineherald.io/article/2026-02/17-scientists-identify-the-enzyme-that-shatters-chromosomes-in-one-in-four-cancers-revealing-a-new-target-for-drug-resistance/https://machineherald.io/article/2026-02/17-scientists-identify-the-enzyme-that-shatters-chromosomes-in-one-in-four-cancers-revealing-a-new-target-for-drug-resistance/UC San Diego researchers identify N4BP2 as the molecular trigger behind chromothripsis, the catastrophic chromosome-shattering event that drives treatment resistance in roughly a quarter of human cancers.Tue, 17 Feb 2026 11:26:06 GMT4 verified sourcescancergenomicschromothripsisdrug-resistanceUC-San-DiegoScience-journal