https://www.biospace.com/all-news All News en-US Mon, 20 Jul 2026 15:11:47 GMT https://www.biospace.com/business/lillys-ataibeckley-buy-validates-space-as-big-pharma-takes-note-of-psychedelics Heather McKenzie Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst cautioned, however, that the transaction should not be seen as “supporting a uniform re-rating of every psychedelic developer.” Mon, 20 Jul 2026 15:11:47 GMT https://www.biospace.com/business/lillys-ataibeckley-buy-validates-space-as-big-pharma-takes-note-of-psychedelics https://www.biospace.com/fda/fdas-radical-transparency-policy-for-rejections-runs-into-legal-uncertainty Nick Paul Taylor Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue. Mon, 20 Jul 2026 14:12:38 GMT https://www.biospace.com/fda/fdas-radical-transparency-policy-for-rejections-runs-into-legal-uncertainty https://www.biospace.com/business/2026-ipo-class-blooms-again-as-blossomhill-latigo-set-sights-on-nasdaq Tristan Manalac Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021. Mon, 20 Jul 2026 12:00:53 GMT https://www.biospace.com/business/2026-ipo-class-blooms-again-as-blossomhill-latigo-set-sights-on-nasdaq https://www.biospace.com/drug-development/vertexs-iga-nephropathy-drug-derisked-after-novartis-vera-approvals Tristan Manalac The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for their recently approved IgAN therapies Fabhalta and Trutakna. Mon, 20 Jul 2026 11:27:03 GMT https://www.biospace.com/drug-development/vertexs-iga-nephropathy-drug-derisked-after-novartis-vera-approvals https://www.biospace.com/drug-development/type-1-diabetes-pipeline-making-remarkable-progress-toward-insulin-independence Michael Gibney After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape with innovative approaches—and experts say there’s room for all of them. Mon, 20 Jul 2026 04:34:00 GMT https://www.biospace.com/drug-development/type-1-diabetes-pipeline-making-remarkable-progress-toward-insulin-independence https://www.biospace.com/business/how-kyverna-rode-car-ts-autoimmune-wave-to-the-fdas-door Annalee Armstrong Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm. Mon, 20 Jul 2026 04:14:00 GMT https://www.biospace.com/business/how-kyverna-rode-car-ts-autoimmune-wave-to-the-fdas-door https://www.biospace.com/drug-development/indias-life-sciences-sector-at-turning-point-for-innovation-report Angela Gabriel Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois. Fri, 17 Jul 2026 15:01:00 GMT https://www.biospace.com/drug-development/indias-life-sciences-sector-at-turning-point-for-innovation-report https://www.biospace.com/business/2026-ipo-stock-tracker-how-biotechs-new-to-public-markets-are-performing Gabrielle Masson BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026. Fri, 17 Jul 2026 14:33:10 GMT https://www.biospace.com/business/2026-ipo-stock-tracker-how-biotechs-new-to-public-markets-are-performing https://www.biospace.com/business/gsk-culls-cough-program-for-drug-at-the-heart-of-2b-bellus-bet-after-phase-3-fail Tristan Manalac Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said. Fri, 17 Jul 2026 12:48:18 GMT https://www.biospace.com/business/gsk-culls-cough-program-for-drug-at-the-heart-of-2b-bellus-bet-after-phase-3-fail https://www.biospace.com/drug-development/insmed-moves-closer-to-6b-opportunity-as-pah-drug-shows-long-term-durability Tristan Manalac Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements through one year of follow-up. Fri, 17 Jul 2026 11:44:14 GMT https://www.biospace.com/drug-development/insmed-moves-closer-to-6b-opportunity-as-pah-drug-shows-long-term-durability https://www.biospace.com/fda/fda-disavows-makary-prasads-papers-as-lawmaker-blasts-shoot-from-the-hip-policymaking Tristan Manalac Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Energy & Commerce committee ranking member Diana DeGette. Fri, 17 Jul 2026 11:13:48 GMT https://www.biospace.com/fda/fda-disavows-makary-prasads-papers-as-lawmaker-blasts-shoot-from-the-hip-policymaking https://www.biospace.com/policy/fdas-first-ai-focused-cgmp-warning-letter-signals-new-scrutiny-for-manufacturers John Potter The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight and quality controls remain essential. Thu, 16 Jul 2026 14:08:25 GMT https://www.biospace.com/policy/fdas-first-ai-focused-cgmp-warning-letter-signals-new-scrutiny-for-manufacturers https://www.biospace.com/deals/lilly-makes-up-to-3-8b-psychedelics-play-in-ataibeckley-takeover Tristan Manalac With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry. Thu, 16 Jul 2026 13:22:46 GMT https://www.biospace.com/deals/lilly-makes-up-to-3-8b-psychedelics-play-in-ataibeckley-takeover https://www.biospace.com/fda/merck-dives-into-cholesterol-with-first-fda-approval-for-oral-pcsk9-inhibitor Gabrielle Masson Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options. Thu, 16 Jul 2026 13:16:02 GMT https://www.biospace.com/fda/merck-dives-into-cholesterol-with-first-fda-approval-for-oral-pcsk9-inhibitor https://www.biospace.com/business/braveheart-attovia-vogenx-keep-ipos-ballooning-with-plans-to-compete-in-cardiometabolic-immuno Tristan Manalac Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is looking to establish its name in the cardiometabolic space. Thu, 16 Jul 2026 12:50:54 GMT https://www.biospace.com/business/braveheart-attovia-vogenx-keep-ipos-ballooning-with-plans-to-compete-in-cardiometabolic-immuno https://www.biospace.com/drug-development/the-future-of-pain-relief-exploring-opioid-alternatives Jennifer C. Smith-Parker BioSpace Insights In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has remained such a difficult therapeutic area to tackle and one of the biggest unmet needs today, and how non-opioid mechanisms to regenerative therapies could reshape the future of treatment. Thu, 16 Jul 2026 12:48:26 GMT https://www.biospace.com/drug-development/the-future-of-pain-relief-exploring-opioid-alternatives https://www.biospace.com/business/j-j-sees-spravato-sales-surge-as-psychedelic-competitors-loom Tristan Manalac Psychedelics, chiefly Compass Pathways' COMP360, are unlikely to make an immediate dent in the sales of Johnson & Johnson’s depression drug Spravato, H.C. Wainwright’s Patrick Trucchio told BioSpace. Thu, 16 Jul 2026 12:14:27 GMT https://www.biospace.com/business/j-j-sees-spravato-sales-surge-as-psychedelic-competitors-loom https://www.biospace.com/job-trends/spurred-by-deep-cuts-and-m-a-activity-h1-layoffs-could-oust-14-000-in-biopharma Angela Gabriel Takeda’s cuts will go the deepest, affecting over 4,700 employees. Layoffs tied to M&A activity include BioNTech letting go of around 800 people at CureVac. Thu, 16 Jul 2026 07:00:00 GMT https://www.biospace.com/job-trends/spurred-by-deep-cuts-and-m-a-activity-h1-layoffs-could-oust-14-000-in-biopharma https://www.biospace.com/business/amid-55b-us-manufacturing-push-j-j-turns-to-streamlining-its-pharma-supply-chain Gabrielle Masson After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain. Wed, 15 Jul 2026 17:52:04 GMT https://www.biospace.com/business/amid-55b-us-manufacturing-push-j-j-turns-to-streamlining-its-pharma-supply-chain https://www.biospace.com/drug-development/keluns-merck-partnered-adc-notches-late-stage-nsclc-win-alongside-keytruda Michael Gibney The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT. Wed, 15 Jul 2026 14:48:09 GMT https://www.biospace.com/drug-development/keluns-merck-partnered-adc-notches-late-stage-nsclc-win-alongside-keytruda