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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...
Big pharma deals: Biogen expands immunology with Apellis
Biogen agreed to acquire Apellis Pharmaceuticals for roughly $5.6 billion in cash, adding two commercial products and immunology nephrology expertise to its portfolio. The deal includes Apellis’...
Regulatory policy: Tariffs targeting imported drugs prepared
The Trump administration has prepared an order that would impose 100% tariffs on imports of patented medications and their active ingredients, according to a STAT report citing a draft obtained in...
HIV pipeline setback: Gilead ends Phase 2/3 long-acting pill trial
Gilead discontinued a Phase 2/3 trial of its long-acting oral HIV regimen after the FDA clinical hold remained in place. The program, Wonders-2, tested a combination of GS-1720 (integrase strand...
Cell therapy manufacturing at scale: more robust AAV process economics
Researchers reported a manufacturing-forward approach to improve upstream stability in large-scale AAV production by reducing the volume and time sensitivity of transfection complex additions. The...
Diagnostics and surveillance: multi-cancer early detection results finalized
Caris Life Sciences shared finalized results for its multi-cancer early detection test Caris Detect from the Achieve I study, lifting shares on the release. The study enrolled 3,014 evaluable...
Company collapse: IO Biotech seeks bankruptcy after cancer vaccine failure
IO Biotech said it will seek bankruptcy protection after a late-stage cancer vaccine effort failed and FDA interactions tightened the path forward. The Danish developer filed an SEC notice stating...
Payer and trial policy: FDA explores using digital health technologies in drug trials
The U.S. FDA is requesting public feedback on draft guidance for the use of digital health technologies (DHTs) in drug development. The notice involves the FDA’s CBER and CDER, aiming to clarify...
AI and clinical care operations: ambient scribe impact in the real world
A large observational study published in JAMA examined how AI-enabled “ambient documentation” systems, or AI scribes, affected clinician workflow in routine practice. The analysis reported small...