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AstraZeneca’s hypophosphatasia enzyme therapy stumbles in pivotal phase
AstraZeneca’s experimental enzyme replacement therapy efzimfotase alfa produced mixed outcomes in three late-stage trials in hypophosphatasia, a rare genetic bone disorder. The results mark...
Immunology M&A: Biogen to buy Apellis for $5.6B
Biogen agreed to acquire Apellis Pharmaceuticals for about $5.6 billion, expanding the Massachusetts-based biotech’s immunology and rare-disease portfolio with two marketed assets. The deal gives...
Sleep medicine M&A: Lilly agrees to buy Centessa for $6.3B
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion in upfront cash, adding a clinical-stage portfolio of orexin receptor 2 (OX2R) agonists for sleep-wake disorders. The...
Oncology: Active surveillance consensus for low-grade NMIBC
A global consensus statement backs active surveillance as a management strategy for patients with low-grade non-muscle-invasive bladder cancer (LG-NMIBC). The approach aims to reduce overtreatment...
Gene therapy/wound care: Hydrogel + AAV8-sTβRII reduces skin scarring
Researchers reported a gene therapy approach that combines a poly-(HA-GMA) hydrogel with AAV8-sTβRII to reduce late-stage fibrosis and minimize skin scarring. The report emphasized that the...
Diagnostics: Caris shares surge after finalized Achieve I multi-cancer early detection results
Caris Life Sciences’ shares rose after the company released finalized Achieve 1 study results for its multi-cancer early detection test, Caris Detect. The Achieve I study enrolled 3,014 patients,...
Dealmaking for rare neurodegeneration: Korsana to go public via reverse merger
Korsana Biosciences is moving to the public markets via a reverse merger with Cyclerion Therapeutics, bringing a large-scale financing package and a pipeline lead for Alzheimer’s disease. The...
Regulatory & policy: FDA looks to reduce data burden to start new drug trials
U.S. FDA Commissioner Marty Makary said the agency wants to speed new drug trials by cutting the amount of data required to initiate studies in the U.S., removing most non-safety components from...
Obesity pills go oral—Lilly secures FDA approval
The U.S. FDA approved Eli Lilly’s once-daily oral GLP-1 obesity drug orforglipron, branded Foundayo, giving the company a direct shot at Novo Nordisk’s oral weight-loss offering after Novo’s...
Mega M&A reshapes neuro and immunology portfolios
Eli Lilly agreed to acquire Centessa Pharmaceuticals for about $6.3 billion upfront (plus contingent value rights), betting its neuroscience cash flow on orexin receptor 2 (OX2R) agonists....
FDA tariffs draft signals new cost pressure on drug imports
A draft order obtained by STAT indicates the Trump administration is preparing 100% tariffs on imports of patented medications and their active ingredients, with timing potentially as soon as...
HIV development disrupted—Gilead terminates long-acting pill trial under FDA hold
Gilead ended a Phase 2/3 trial of two long-acting HIV pills after FDA concerns led to a clinical hold that remained in place. The company discontinued safety follow-up for the Wonders-2 study,...
Caris ‘Achieve I’ finalized data lifts confidence in multi-cancer early detection
Caris Life Sciences reported finalized Achieve 1 study results for its multi-cancer early detection test, Caris Detect, sending shares higher. The study enrolled 3,014 patients who were evaluable...
Gene therapy delivery—tissue-targeting hydrogel reduces skin scarring
Researchers developed an AAV8-sTβRII hydrogel delivery system that reduced late-stage fibrosis and skin scarring in a gene therapy framework combining biomaterials with targeted genetic...
Regenerative manufacturing—place-of-care gene-modified HSC collaboration advances toward Phase I/II
A new partnership set out to develop and manufacture patient-accessible, place-of-care hematopoietic stem cell (HSC) cell and gene therapy workflows for diseases including sickle cell disease and...
Biotech lab automation—digital formulator links to self-driving tableting
A new drug formulation and manufacturing platform combines a “digital formulator” with automated tableting to accelerate the development cycle from formulation design through production steps. The...
Diagnostics—Baebies expands CLIA-waived molecular testing on a POC platform
Baebies received 510(k) clearance and a CLIA waiver for a triplex respiratory test running on its Finder point-of-care system, pairing molecular detection with other clinical chemistry/coagulation...
Company setback—IO Biotech files for bankruptcy after failed cancer vaccine outcome
IO Biotech announced it will file for bankruptcy after its cancer vaccine program failed in a key trial, according to an SEC filing. The Danish company’s decision follows an earlier FDA refusal...
Obesity drugs: oral GLP-1 race heats up
The FDA approved Eli Lilly’s once-daily oral GLP-1 weight-loss pill Foundayo (orforglipron), setting up head-to-head commercial pressure against Novo Nordisk’s recently launched oral Wegovy pill....
Big pharma deals: Lilly enters sleep disorder neuroscience
Eli Lilly agreed to acquire Centessa Pharmaceuticals in a deal valued at about $6.3 billion upfront, with additional contingent value rights that could add $1.5 billion tied to approvals in...