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The Progress Profile: Alzheimer’s Research in Focus podcast returns for Season 2, featuring four episodes that delve into critical conversations about Alzheimer’s and brain health. Episodes cover bridging science and lived experience, policy and equity in dementia care, advocacy and awareness across neurodegenerative diseases, and patient perspectives on risk and prevention. Experts including Dr. John Harrison, Dr. Lon Schneider, Dr. Stephen Salloway, Dr. Phyllis Ferrell, Maria Carrillo, Ph.D., and Dr. Wiesje van der Flier discuss advances in early detection, blood-based diagnostics, emerging therapies, and the importance of patient and caregiver perspectives in shaping research and care.
The Progress Profile: Alzheimer’s Research in Focus podcast is back for Season 2, building on Season 1 to delve deeper into neurodegenerative disease. The season features four episodes: Ep. 1 discusses bridging clinical trial design and frontline care with Dr. John Harrison, Dr. Lon Schneider, and Dr. Stephen Salloway; Ep. 2 explores policy, equity, and the expanding dementia landscape with Dr. Phyllis Ferrell; Ep. 3 covers awareness and advocacy across neurodegenerative diseases with Maria Carrillo, Ph.D.; and Ep. 4 examines patient perspectives on risk, prevention, and empowerment with Dr. Wiesje van der Flier. The podcast is filed under Pharma, Clinical Trials, and Marketing.
GE HealthCare said Monday it will acquire Sofie Biosciences for $945 million in cash, adding a U.S. contract manufacturing network for PET radiopharmaceuticals. The deal, expected to close in the first half of 2027, will integrate Sofie into GE HealthCare's pharmaceutical diagnostics business, PDx, and includes U.S. rights to the pipeline radiotracer FAPI-74. Sofie, which already manufactures GE HealthCare's Flyrcado F18 injection, will remain an independent manufacturing partner to its customers and operate its 15 U.S. CMO sites. GE HealthCare expects the acquisition to contribute to revenue growth and adjusted EPS in the first full year of ownership.
Shionogi announced a $2 billion cash acquisition of IntraBio, gaining Aqneursa, a drug approved for Niemann-Pick disease type C and Ataxia-Telangiectasia. The deal will make IntraBio a wholly owned subsidiary of Shionogi's U.S. division and bolster Shionogi's rare disease portfolio, which includes Radicava. IntraBio reported $68 million in 2025 sales. Shionogi will assess the transaction's impact on its financial outlook for the fiscal year ending next March.
The Nobel Prize in Physiology or Medicine has been awarded to Peter Hegemann, Georg Nagel, and Karl Deisseroth for their work on optogenetics, a method using light to control neurons. In business news, Alector has licensed its enzyme replacement therapy AL050 to Roche's Genentech for $100 million upfront and up to $1.17 billion in milestones; CSL will pay Alentis Therapeutics up to $1.6 billion to co-develop the kidney disease drug lixudebart; the FDA has expanded approval of Eli Lilly's Jaypirca as a first-line treatment for certain leukemias; and Bayer plans to invest $2.2 billion in a new drug manufacturing site in New Albany, Ohio.
Foghorn Therapeutics is cutting 40% of its staff and discontinuing its FHD-909 program and a second SMARCA2-targeted drug after the cancer drug developed with Eli Lilly failed to meet efficacy benchmarks. Wave Life Sciences received FDA clearance for an accelerated approval pathway for its RNA editing treatment for alpha-1 antitrypsin deficiency. Samsung Bioepis and Teva expanded their partnership to develop six biosimilars. Varda Space Industries raised $251 million in a Series D round. Hatteras Venture Partners appointed Andrew Witty as chairman and Ned Sharpless as managing director of a drug discovery initiative, and announced the first closing of a $100 million fund.
Sanofi and Regeneron have expanded their alliance to develop new immune-regulating drugs similar to Dupixent. The companies will co-develop and co-commercialize four long-acting, Regeneron-invented antibodies targeting IL-13 and/or IL-4, with the most advanced candidate, REGN20423, in early-stage trials for eczema. Regeneron will lead R&D and receive $1 billion upfront, with up to $7 billion in milestone payments. Sanofi will handle global commercialization. The existing profit-sharing agreement for Dupixent remains unchanged. The move may help address patent expiration concerns and sets the stage for future collaborations.
The third quarter of 2026 brought stability to the FDA under acting commissioner Kyle Diamantas, with advisory committees resuming and permanent directors appointed at CDER and CBER. However, the confirmation of White House policy aide Heidi Overton as commissioner remains uncertain due to a tight Senate window before the midterms. In the fourth quarter, critical decisions are expected on a first-of-its-kind cancer immunotherapy, a functional cure for hepatitis B, and other notable products. This article outlines five key FDA decisions to watch.
The FDA has accepted Roche's approval application for fenebrutinib, an experimental BTK inhibitor for relapsing and primary progressive multiple sclerosis, and initiated a priority review with a six-month timeline. The application is based on three late-stage studies that met their main goals, but an imbalance in deaths among treatment recipients and pre-existing liver safety concerns could complicate approval. Fenebrutinib would be the first of its kind approved in both MS settings if cleared.
Beam Therapeutics sued YolTech Therapeutics and Serapha Bio on Sept. 25 in U.S. District Court in Massachusetts, alleging that former employee Zi Jun “Emma” Wang secretly founded YolTech while at Beam and later filed patent applications based on Beam's confidential information. The complaint also names YolTech CEO Yuxuan “Jensen” Wu as a defendant. Beam claims YolTech licensed an AATD program to Serapha that uses base editing technology derived from Beam's trade secrets. Serapha denies the allegations and vows to defend itself. The therapy, SERP-01, targets the same mutation as Beam's BEAM-302.