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GLP-1 obesity-to-diabetes expansion with cardiovascular and liver safety data
Eli Lilly’s oral GLP-1 obesity drug Foundayo (orforglipron) cleared a key heart-safety hurdle in people with diabetes, meeting non-inferiority versus insulin glargine in a cardiovascular outcomes...
FDA priority review for B7-H3 ADC in extensive-stage small-cell lung cancer
The FDA granted priority review to Daiichi Sankyo and Merck’s ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate, for advanced extensive-stage small-cell lung cancer. The accelerated...
Groundbreaking Phase 3 setback recovery effort for Elevidys in Europe
Roche will start a new global Phase 3 trial for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys after Europe delivered a negative opinion. The study plans to randomize...
Major next-generation diagnostics deal: Foundation Medicine to acquire Saga Diagnostics’ Pathlight MRD platform
Roche subsidiary Foundation Medicine agreed to buy Saga Diagnostics to expand its molecular residual disease (MRD) portfolio, paying up to $595 million. The acquisition brings Saga’s Pathlight...
RNA epigenetics momentum: Storm raises Series C and treats first patient in sarcoma Phase 2
Storm Therapeutics secured a $56 million Series C to advance STC-15, its RNA enzyme inhibitor targeting myo- and liposarcomas, and reported that the first patient has been treated in a new Phase 2...
HIV remission case strengthens CCR5Δ32 HSCT signal
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. Published in...
Cell therapy trial readout risk/reward: demethylation-primed dual CD19/CD20 CAR T in lymphoma
Investigators reported early promise from a Phase 1/2a trial of demethylation-primed tandem CD19/CD20 CAR T cells in relapsed or refractory B-cell lymphomas. The approach combines epigenetic...
Startup funding to move protein diagnostics forward via single-molecule amplification tech
Finnish protein sensing startup Proteins.1 raised €4.7 million in pre-seed funding to develop enzyme-free, single-molecule protein amplification for diagnostics. The round was led by Lifeline...
Med-tech/diagnostics revenue volatility: QuidelOrtho’s Q1 dragged by respiratory season softness and China slowness
QuidelOrtho reported preliminary Q1 2026 revenue of $615 million to $620 million, down about 11% at the midpoint versus Q1 2025, citing a lighter respiratory season and slower distributor sales in...
Cancer diagnostics workflow automation: Invivoscribe launches PrepQuant to standardize pre-analytical steps
Invivoscribe introduced PrepQuant, an integrated sample preparation platform designed to standardize nucleic-acid extraction, concentration, and quantification in a single automated instrument....
Obesity GLP-1 competition shifts to liver and safety surveillance
Eli Lilly said its oral obesity drug Foundayo met the main goal of a cardiovascular outcomes study in people with diabetes, showing no greater risk of heart attacks and other cardiovascular events...
Roche reopens Elevidys path toward European approval
Roche announced a new global Phase 3 trial for Duchenne muscular dystrophy gene therapy Elevidys as it tries again for European approval after prior negative European Medicines Agency feedback....
Revolution Medicines’ daraxonrasib swings trial-level momentum and taps capital markets
Revolution Medicines reported Phase 3 results for daraxonrasib (RMC-6236), a RAS-targeting inhibitor in metastatic pancreatic ductal adenocarcinoma, showing longer progression-free survival and...
Cochrane verdict reignites the anti-amyloid Alzheimer’s drug debate
A sweeping Cochrane review concluded that anti-amyloid antibody drugs in Alzheimer’s disease produce “no meaningful difference” for patients with mild cognitive impairment or mild dementia. The...
MeiraGTx buys back failed J&J eye gene therapy, while Storm funds a new sarcoma trial
MeiraGTx agreed to buy back full rights to bota-vec, an eye gene therapy previously backed by Johnson & Johnson after a Phase 3 failure in X-linked retinitis pigmentosa. The deal brings the asset...
Beeline Medicines launches from Bain and brings Bristol Myers immune assets back into play
Bain Capital launched Beeline Medicines, a new company seeded with five Bristol Myers Squibb immunology programs after the licensing deal that took place last year. The startup emerged from...
FDA continues to scrutinize compounded peptides as regulatory stance shifts
The FDA is moving toward easing restrictions on certain peptides by convening advisory panel discussions about whether compounding pharmacies should be allowed to make products that were...
Cancer diagnostics get a major Roche expansion via Saga MRD testing
Roche said it will acquire Saga Diagnostics for up to $595 million through Foundation Medicine, expanding its molecular residual disease testing portfolio. The deal includes milestone payments and...
AbbVie expands pain portfolio via Haisco licensing deal
AbbVie secured rights to develop, manufacture, and commercialize Haisco’s portfolio of pain compounds outside mainland China, Hong Kong, and Macau under a licensing agreement worth $745 million....
Terremoto raises $108M to advance oral AKT1 inhibitors into the clinic
Terremoto Biosciences raised $108 million in a Series C to develop small-molecule medicines targeting AKT, funding further first-in-human progress for oral candidates. New investors include RA...