https://www.biospace.com/all-news All News en-US Fri, 11 Sep 2026 13:22:30 GMT https://www.biospace.com/events/webinar-the-insiders-guide-to-leveraging-podcasts-webinars-and-thought-leadership-programs BioSpace Insights Join BioSpace's Managing Editor, Director of Insights and Vice President of Marketing for an inside look at how PR, communications and marketing teams can successfully leverage webinars, podcasts and integrated content campaigns to elevate executive voices, share industry expertise and engage key biotech and pharma audiences. Fri, 11 Sep 2026 13:22:30 GMT https://www.biospace.com/events/webinar-the-insiders-guide-to-leveraging-podcasts-webinars-and-thought-leadership-programs https://www.biospace.com/drug-delivery/samsung-biologics-inks-262m-manufacturing-deal-with-european-pharma-company Nick Paul Taylor The agreement, which runs through 2033, comes as Samsung Biologics continues to expand its large manufacturing footprint in South Korea. Fri, 11 Sep 2026 13:19:28 GMT https://www.biospace.com/drug-delivery/samsung-biologics-inks-262m-manufacturing-deal-with-european-pharma-company https://www.biospace.com/drug-development/disc-sets-up-polycythemia-vera-challenge-but-silence-maintains-lead Tristan Manalac The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the FDA’s approval last month for Mimrylo. Fri, 11 Sep 2026 12:30:13 GMT https://www.biospace.com/drug-development/disc-sets-up-polycythemia-vera-challenge-but-silence-maintains-lead https://www.biospace.com/business/frazier-adds-1-1b-to-small-and-mid-sized-biotech-fund Tristan Manalac Frazier’s life science fund has already benefited several successful biotechs, including Verona Pharma, which was acquired by Merck for $10 billion, and Carmot Therapeutics, which Roche bought for $2.7 billion. Fri, 11 Sep 2026 12:25:25 GMT https://www.biospace.com/business/frazier-adds-1-1b-to-small-and-mid-sized-biotech-fund https://www.biospace.com/business/novartis-drags-peers-down-with-trip-asset-stumble Annalee Armstrong Novartis’ shares fell 13% this week after the report of three separate late-stage asset setbacks. The impact went beyond the Swiss drugmaker, dragging peers down across the market. Fri, 11 Sep 2026 10:00:00 GMT https://www.biospace.com/business/novartis-drags-peers-down-with-trip-asset-stumble https://www.biospace.com/fda/mikhail-davis-embody-the-fdas-stabilization-seehafer-signals-ai-revolution-is-coming Jef Akst Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence. Fri, 11 Sep 2026 04:32:00 GMT https://www.biospace.com/fda/mikhail-davis-embody-the-fdas-stabilization-seehafer-signals-ai-revolution-is-coming https://www.biospace.com/business/novartis-board-faces-investor-scrutiny-after-m-a-misfires-and-r-d-flops Nick Paul Taylor Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s. Fri, 11 Sep 2026 04:01:00 GMT https://www.biospace.com/business/novartis-board-faces-investor-scrutiny-after-m-a-misfires-and-r-d-flops https://www.biospace.com/business/takedas-long-term-r-d-head-announces-exit-after-major-pipeline-reorganization Gabrielle Masson A few months after a new CEO stepped up to helm Takeda, the drugmaker will now have to prepare for another leadership change as its long-time R&D head plans his exit. Thu, 10 Sep 2026 17:39:33 GMT https://www.biospace.com/business/takedas-long-term-r-d-head-announces-exit-after-major-pipeline-reorganization https://www.biospace.com/fda/biohaven-takes-another-hit-as-fda-pauses-enrollment-in-pivotal-trials-for-embattled-epilepsy-drug Heather McKenzie The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025. Thu, 10 Sep 2026 14:04:36 GMT https://www.biospace.com/fda/biohaven-takes-another-hit-as-fda-pauses-enrollment-in-pivotal-trials-for-embattled-epilepsy-drug https://www.biospace.com/drug-development/drugmakers-cherry-pick-launch-regions-as-mfn-creates-policy-environment-like-an-earthquake Annalee Armstrong With multiple drug pricing initiatives like Most Favored Nation now in force, drugmakers have to reinvent their commercial strategies to stay ahead of the fast-moving policy environment, according to a new report from Numerof & Associates. Thu, 10 Sep 2026 13:26:46 GMT https://www.biospace.com/drug-development/drugmakers-cherry-pick-launch-regions-as-mfn-creates-policy-environment-like-an-earthquake https://www.biospace.com/business/encoded-raises-275m-series-f-for-dravet-syndrome-gene-therapy Tristan Manalac Encoded Therapeutics’ lead asset ETX101 is a gene therapy being tested for Dravet syndrome. Phase 1/2 data showed substantial reductions in seizures. Thu, 10 Sep 2026 13:07:09 GMT https://www.biospace.com/business/encoded-raises-275m-series-f-for-dravet-syndrome-gene-therapy https://www.biospace.com/drug-development/tyra-shares-slip-as-bladder-cancer-responses-fall-short-of-investor-expectations Tristan Manalac Despite falling short of analyst expectations, Tyra Biosciences is taking its cancer drug to registrational development for non-muscle invasive bladder cancer. Thu, 10 Sep 2026 12:24:41 GMT https://www.biospace.com/drug-development/tyra-shares-slip-as-bladder-cancer-responses-fall-short-of-investor-expectations https://www.biospace.com/drug-delivery/the-supply-chain-fault-lines-of-modern-pharma Jennifer C. Smith-Parker BioSpace Insights In this episode of Denatured, sponsored by SK pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we explore how CDMOs are reshaping supply‑chain strategy for a new generation of complex modalities. Thu, 10 Sep 2026 11:08:18 GMT https://www.biospace.com/drug-delivery/the-supply-chain-fault-lines-of-modern-pharma https://www.biospace.com/job-trends/11-companies-hiring-in-california-now Angela Gabriel Looking for a biopharma job in California? Check out the BioSpace list of 11 companies hiring life sciences professionals like you. Thu, 10 Sep 2026 07:00:00 GMT https://www.biospace.com/job-trends/11-companies-hiring-in-california-now https://www.biospace.com/job-trends/august-biopharma-layoffs-impact-just-over-500-down-90-year-over-year Angela Gabriel Last month, biotech and pharma companies making or planning workforce cuts included three whose reductions will more than halve their workforces. Blueprint Medicines’ layoffs will affect the most employees. Thu, 10 Sep 2026 07:00:00 GMT https://www.biospace.com/job-trends/august-biopharma-layoffs-impact-just-over-500-down-90-year-over-year https://www.biospace.com/job-trends/from-process-to-intelligence-how-ai-is-reshaping-people-strategy-in-life-sciences Chantal Dresner Applying artificial intelligence and automation tactics has played a large role in talent strategy conversations in the past few years. While many organizations initially focused on experimenting with tools and driving adoption to create efficiencies, leading employers are now asking deeper questions. Thu, 10 Sep 2026 07:00:00 GMT https://www.biospace.com/job-trends/from-process-to-intelligence-how-ai-is-reshaping-people-strategy-in-life-sciences https://www.biospace.com/fda/opinion-for-pdufa-viii-the-most-valuable-incentive-may-be-time Jeremy Levin The FDA’s proposal to offer 50% off application fees for drugs with early-stage trials conducted in the U.S. is unlikely to achieve the intended result. What biotechs really want is speed. Thu, 10 Sep 2026 04:42:00 GMT https://www.biospace.com/fda/opinion-for-pdufa-viii-the-most-valuable-incentive-may-be-time https://www.biospace.com/biospace-layoff-tracker BioSpace Editorial Staff Follow along as BioSpace tracks job cuts and restructuring initiatives. Wed, 09 Sep 2026 23:22:00 GMT https://www.biospace.com/biospace-layoff-tracker https://www.biospace.com/events/webinar-the-massive-scale-of-glp-1s-evolving-health-healthcare-and-markets Jef Akst Watch this discussion on how GLP-1 drugs for obesity are changing the shape of U.S. healthcare. From direct-to-consumer portals to pharmacy deals, how these drugs reach patients is changing—and leading to debates over pricing and coverage. Learn how your company can be both patient-forward while also maximizing revenue in this unique environment. Wed, 09 Sep 2026 13:56:42 GMT https://www.biospace.com/events/webinar-the-massive-scale-of-glp-1s-evolving-health-healthcare-and-markets https://www.biospace.com/drug-delivery/sandoz-plans-vast-and-vertically-integrated-supply-chain-to-support-100-biosimilar-vision Nick Paul Taylor The company is investing billions of dollars to construct a European biosimilar hub capable of supporting the rapid expansion of its portfolio. Wed, 09 Sep 2026 13:00:53 GMT https://www.biospace.com/drug-delivery/sandoz-plans-vast-and-vertically-integrated-supply-chain-to-support-100-biosimilar-vision