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FDA clears Waskyra — first gene therapy approved from a nonprofit sponsor
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome developed by Fondazione Telethon, marking the first regulatory green light for a gene therapy originating from a nonprofit...
Lilly’s triple agonist: blowout efficacy, tolerability questions
Eli Lilly reported pivotal Phase 3 data showing its triple-agonist obesity candidate delivered unprecedented weight loss but drove higher-than-expected discontinuation rates. Company-released and...
Rezolute’s Phase 3 flop: hypoglycemia drug fails, stock collapses
Rezolute said its Phase 3 study of ersodetug in congenital hyperinsulinism missed the primary efficacy endpoint, prompting an immediate, severe market reaction and management to seek regulatory...
Parse and Tahoe commit to 300M-cell atlas to train biology AI
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300 million single-cell perturbation atlas to train AI models that predict therapeutic outcomes. Parse will use its...
Natera buys Foresight to boost MRD sensitivity and enter hematology
Natera agreed to acquire Foresight Diagnostics for $275 million upfront plus up to $175 million in milestone earnouts to integrate Foresight’s phased-variant PhaseED-seq technology into Signatera...
Moderna taps Nanexa’s PharmaShell to pursue long‑acting injectables
Moderna struck a heavily back‑loaded collaboration with Swedish formulation specialist Nanexa to assess the PharmaShell platform for up to five injectable drug programs. Moderna paid $3 million...
Novartis and Relation agree $1.7B AI‑driven drug discovery pact
Novartis signed a strategic collaboration with UK AI‑driven biotech Relation Therapeutics to discover and advance drug targets for atopic diseases, with up to $1.7 billion in preclinical,...
FDA approves Waskyra: first gene therapy cleared from a nonprofit sponsor
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome, marking the first U.S. authorization of a gene therapy developed and filed by a nonprofit applicant, Fondazione Telethon. The...
ARPA‑H funds AI toxicity models: Inductive Bio to lead DATAMAP
Inductive Bio won an award of up to $21 million from ARPA‑H to lead a consortium building next‑generation AI models for drug toxicity prediction (DATAMAP). The industrial‑academic team includes...
Paradigm acquires Flatiron CRU, raises $78M to expand trial reach
Paradigm Health acquired Flatiron Health’s clinical research business and simultaneously closed a $78 million Series B to expand its community oncology trial network. The deal folds Flatiron’s CRU...
FDA signals stricter bar for CAR‑T approvals: RCTs preferred
Officials at FDA’s Center for Biologics Evaluation and Research told JAMA and industry stakeholders the agency will generally favor randomized controlled trials (RCTs) with survival or acceptable...
Novartis taps Relation: $1.7bn AI tie-up for atopic targets
Novartis and UK AI-driven biotech Relation Therapeutics agreed a multi-program collaboration to discover and advance targets for atopic and immune-dysregulation diseases. Relation will receive an...
Moderna picks Nanexa: PharmaShell option could reshape injectable release
Moderna signed a heavily back‑loaded collaboration with Swedish long‑acting formulation company Nanexa to test its PharmaShell microparticle coating on up to five injectable programs. Moderna paid...
FDA okays nonprofit gene therapy: Waskyra clears historic regulatory hurdle
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome, marking the first FDA authorization of a gene therapy developed and filed by a nonprofit sponsor. Regulators highlighted...
FDA shifts CAR‑T standard: randomized trials now expected
Senior officials at the FDA’s Center for Biologics Evaluation and Research signalled a policy shift that will generally require randomized controlled trials (RCTs) with survival or time‑to‑event...
Lilly’s retatrutide... dramatic weight loss, tolerability questions emerge
Eli Lilly disclosed late‑stage data showing its triple‑agonist retatrutide produced exceptionally large weight losses in obesity trials, including multi‑percent reductions that exceeded...
Prolynx raises $70M: hires Amgen obesity vet to push long‑acting injectables
Prolynx secured $70 million in financing to advance its long‑acting obesity drug platform that uses proprietary linker chemistry to create monthly or quarterly versions of incretin and...
Biotech follow‑ons smash record: $3.2B floods market in single wave
Eight biotech companies sold follow‑on offerings that collectively raised over $3.2 billion in a single overnight session, marking a record day for the sector’s capital markets. Most deals were...
ARPA‑H backs AI toxicity models: industry consortium to build non‑animal predictors
Inductive Bio won an award — up to $21 million — from ARPA‑H to lead an industrial‑academic consortium developing next‑generation AI models for drug toxicity prediction, focusing initially on...
In‑vivo CAR‑T data fuel momentum: single‑dose approaches show promise
Kelonia Therapeutics presented in‑vivo CAR‑T data that showed efficacy signals in multiple myeloma models and early clinical reports, bolstering confidence in intramuscular or systemic delivery...