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Obesity drug development – cardiovascular and liver safety data
Eli Lilly’s oral obesity drug Foundayo (orforglipron) cleared key cardiovascular safety scrutiny in the Phase 3 Achieve-4 trial in adults with type 2 diabetes and obesity or overweight at...
Malaria diagnostics – FDA approval for blood-donor risk screening
Grifols won US FDA approval for a nucleic-acid-based assay to screen blood donors for malaria risk. The Procleix Plasmodium Assay is automated on the Procleix Panther system and detects ribosomal...
Cancer therapeutics – FDA priority review for B7-H3 ADC in small-cell lung cancer
The US FDA granted priority review to Daiichi Sankyo and Merck’s B7-H3-directed antibody-drug conjugate ifinatamab deruxtecan. The decision applies to the BLA for patients with advanced...
Pancreatic cancer – Phase 3 success and capital market response
Revolution Medicines’ Phase 3 RAS inhibitor daraxonrasib delivered a major clinical signal in metastatic pancreatic ductal adenocarcinoma, with top-line results tied to longer survival versus...
Sarcoma precision oncology – STC-15 enters Phase 2 with fresh funding
Storm Therapeutics closed a $56 million Series C to drive STC-15 into Phase 2 evaluation across sarcoma indications. The RNA epigenetics program targets METTL3, an enzyme involved in mRNA...
Diagnostics and MRD – Roche to acquire Saga Diagnostics’ Pathlight platform
Roche, via its subsidiary Foundation Medicine, agreed to acquire Saga Diagnostics in a deal valued at up to $595 million, expanding Foundation’s molecular residual disease (MRD) footprint. The...
Digital health – CMS rolls out Medicare app ‘App Store’ to distribute vetted digital health tools
CMS is launching a Medicare-focused digital health ecosystem that functions like an “App Store,” aiming to make patient data more portable across a curated set of digital health apps. The program...
Gene editing and antiviral platforms – FDA guidance and policy shifts on gene therapies
The FDA issued draft guidance on assessing the safety of gene-edited products, focusing on next-generation sequencing-based approaches and bioinformatics methods to characterize risks such as...
Immunology startup launch – Bain capital seeds Beeline Medicines with BMS-licensed assets
Bain Capital Life Sciences officially launched Beeline Medicines as a new immunology-focused biotech, built around five Bristol Myers Squibb programs originally licensed for development. The...
Biotech capital markets – benchmark-setting IPO and obesity pipeline funding
Kailera Therapeutics priced a $625 million IPO, positioning the obesity-focused developer among the largest biotech offerings in the past several years. The company said it will use proceeds to...
Obesity and diabetes therapeutics: Foundayo clears heart safety hurdle; FDA seeks liver-risk data
Eli Lilly said its oral GLP-1 receptor agonist Foundayo (orforglipron) met the primary goal of a cardiovascular outcomes safety test in people with diabetes and obesity, showing no greater risk of...
FDA regulatory posture on peptides: agency moves toward advisory review and potential easing
The FDA is moving toward reconsidering restrictions on compounded “popular peptides,” setting up advisory panel review sessions as the agency evaluates whether a handful of peptide products should...
HIV remission signal with CCR5Δ32 donor transplant – report highlights durable clinical outcome
Researchers reported long-term remission of HIV-1 in a patient who received an allogeneic hematopoietic stem cell transplant from a sibling donor carrying the CCR5Δ32/Δ32 mutation. The result,...
Gene-editing immune cell “protein factory” platform advances in Science – CRISPR HSPC reprogramming
Rockefeller University scientists presented a CRISPR-based strategy that reprograms hematopoietic stem and progenitor cells (HSPCs) to produce engineered B-lymphocyte protein “factories.” In mice,...
Biotech capital markets: Revolution Medicines raises $1.5B after Phase 3 daraxonrasib win
Revolution Medicines priced a $1.5 billion follow-on offering and accompanying convertible notes only days after reporting Phase 3 top-line results for daraxonrasib in metastatic pancreatic ductal...
Clinical oncology: daraxonrasib Phase 3 results extend survival in metastatic pancreatic cancer
Revolution Medicines reported positive Phase 3 results for its orally administered RAS-targeting inhibitor daraxonrasib in metastatic pancreatic ductal adenocarcinoma, with outcomes reportedly...
FDA review pipeline: priority review granted for Merck–Daiichi B7-H3 ADC in extensive-stage small-cell lung cancer
The FDA accepted and granted priority review to Daiichi Sankyo and Merck for ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate being evaluated for advanced extensive-stage small-cell...
Diagnostics regulation and market access: Grifols malaria risk donor screening assay approved by FDA
Grifols said the FDA approved its automated Procleix Plasmodium Assay for screening blood donors for malaria risk. The assay is designed for use with the Procleix Panther system and detects...
Med-tech transactions: CareDx to divest lab products business to EuroBio for $170M
CareDx announced a definitive agreement to sell its lab products business to EuroBio Scientific for $170 million in cash. Under the deal, CareDx will provide transition services for at least six...
Structural biology infrastructure: NIH renews Illinois Tech-led BioCAT funding at Argonne APS
Illinois Tech-led BioCAT at Argonne National Laboratory’s Advanced Photon Source secured a $2.6 million renewal award from NIH’s National Institute of General Medical Sciences (NIGMS). The funding...