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Latest Biotech News

Milvexian fails key trial: BMS and J&J stop acute coronary study

November 15, 2025

Bristol Myers Squibb and Johnson & Johnson halted one of three Phase III trials of milvexian, a selective factor XIa inhibitor, after an interim analysis showed futility for the acute coronary...

Lundbeck disrupts Alkermes’ Avadel deal: higher unsolicited offer arrives

November 15, 2025

Lundbeck submitted an unsolicited higher cash offer for Avadel Pharmaceuticals, challenging a prior agreement between Avadel and Alkermes and igniting a bidding war over Lumryz, a marketed...

FDA restricts Elevidys: Sarepta gene therapy label tightened

November 15, 2025

The U.S. FDA revised the label for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys, adding a boxed safety warning and limiting use to ambulatory patients, and requested...

Medicxi closes €500M Fund V: renewed bet on asset‑centric startups

November 15, 2025

European venture firm Medicxi closed a €500 million Fund V to back asset‑centric biotechnology companies and opportunistic later‑stage investments. The oversubscribed fund continues Medicxi’s...

MD Anderson unveils $2.5B campaign: fundraising to transform cancer care

November 15, 2025

The University of Texas MD Anderson Cancer Center launched a $2.5 billion philanthropic campaign, 'Only Possible Here — The Campaign to End Cancer,' aimed at accelerating cancer research,...

Multi‑omics expose pig‑to‑human kidney immune barriers: rejection reversible

November 15, 2025

Researchers reported multi‑omics and physiologic analyses from a pig‑to‑human kidney xenotransplant in a brain‑dead recipient, mapping immune responses over a 61‑day period and identifying...

EMA advisers back five products: Telethon gene therapy for Wiskott‑Aldrich among them

November 15, 2025

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new products, including a gene therapy developed by Fondazione Telethon for Wiskott‑Aldrich...

Merck stakes $9.2B on Cidara’s long-acting flu candidate

November 15, 2025

Merck agreed to acquire Cidara Therapeutics for $9.2 billion to secure CD-388, a late-stage, long-acting antiviral designed to prevent influenza. The deal gives Merck a phase‑3 program that showed...

FDA narrows Elevidys label: boxed warning, ambulatory‑only restriction

November 15, 2025

The U.S. Food and Drug Administration revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys, adding a boxed safety warning and restricting use to ambulatory patients...

Lundbeck’s unsolicited bid ignites Avadel fight – Alkermes under pressure

November 15, 2025

Lundbeck submitted an unsolicited, higher offer for Avadel Pharmaceuticals, topping Alkermes’ earlier $2.1 billion agreement and setting off a bidding standoff for the Dublin‑based sleep‑disorder...

FDA clears Komzifti – new menin inhibitor approved for NPM1‑mutant AML

November 15, 2025

The FDA approved Kura Oncology and Kyowa Kirin’s ziftomenib (Komzifti) to treat relapsed or refractory acute myeloid leukemia with NPM1 mutations, based on phase II Komet‑001 data showing...

Pfizer closes up to $10B Metsera buy – fast‑acting obesity play locked in

November 15, 2025

Pfizer completed its acquisition of Metsera in a deal worth up to $10 billion, securing a fast‑acting amylin analog and a long‑acting GLP‑1 asset in a crowded obesity market. The close ends a...

Multi‑omics in pig‑to‑human kidney grafts maps rejection — and reversal

November 15, 2025

Researchers performed comprehensive multi‑omic and physiological profiling on a genetically engineered pig kidney transplanted into a brain‑dead human recipient and identified antibody‑ and...

Terasaki, Caltech win CIRM grant — Japan panel nudges embryo‑from‑stem‑cells path

November 15, 2025

The Terasaki Institute and Caltech secured a $2.8 million CIRM Discovery grant to study early human embryo formation using stem‑cell models, signaling renewed institutional investment in...

AI tools push drug‑target prediction and rapid resistance detection

November 15, 2025

Researchers released two AI‑driven advances: DeepTarget, a computational platform that predicts anti‑cancer mechanisms of small molecules and challenges single‑target drug paradigms; and...

CHMP recommends new medicines: Sanofi diabetes, Lilly SERD and five more

November 15, 2025

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued recommendations that include a Sanofi drug for type‑1 diabetes, Eli Lilly’s oral selective estrogen...

AMP issues draft guidelines for reporting cancer sequencing variants

November 15, 2025

The Association for Molecular Pathology’s AMP Group released draft guidelines for interpreting and reporting cancer sequencing variants, covering biomarkers for therapy response/resistance, liquid...

Merck stakes $9.2B on Cidara – buys late‑stage flu antiviral

November 15, 2025

Merck agreed to acquire San Diego biotech Cidara Therapeutics for $9.2 billion to secure CD‑388, a long‑acting antiviral aimed at season‑long prevention of influenza A and B. The deal prices...

Pfizer seals up to $10B Metsera deal – picks up fast‑acting obesity asset

November 15, 2025

Pfizer completed its acquisition of Metsera in a transaction worth up to $10 billion, gaining the obesity biotech’s fast‑acting amylin/GLP assets and a long‑acting GLP‑1. The deal ends a...

Lundbeck jumps into Avadel fight – forces Alkermes into tougher spot

November 15, 2025

Danish drugmaker Lundbeck filed an unsolicited offer for Avadel Pharmaceuticals that topped an earlier agreement between Avadel and Alkermes, igniting a cross‑border bidding tussle over a marketed...