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Latest Biotech News

4DMT sells APAC rights to fund phase 3—Otsuka deal backs retinal gene therapy

November 02, 2025

4D Molecular Therapeutics agreed to sell Asia‑Pacific rights to its retinal gene therapy 4D‑150 to Otsuka Pharmaceutical for $85 million upfront and up to $336 million in milestones, the companies...

Patent cliff looms: $230B of blockbusters face 2026–2029 expiries

November 02, 2025

GEN released an analysis identifying the top 20 drugs whose key U.S. patents expire between 2026 and 2029, representing roughly $176–230 billion in combined annual sales at risk. The list and...

Pfizer sues to enforce Metsera deal — Novo Nordisk counters with higher bid

November 01, 2025

Pfizer filed suit in the Delaware Court of Chancery to block Metsera’s board from terminating a $4.9 billion merger agreement after Novo Nordisk surfaced with a higher, unconventional takeover...

FDA places Intellia’s CRISPR candidate on hold after liver events

November 01, 2025

The U.S. Food and Drug Administration has imposed a clinical hold on Intellia Therapeutics’ two Phase 3 studies of nexiguran ziclumeran (nex‑z), a CRISPR‑based in vivo genome‑editing therapy for...

UCL–UCLA gene therapy posts near‑complete success in ADA‑SCID follow‑up

November 01, 2025

A joint University College London and UCLA gene‑therapy program reported multi‑year follow‑up data showing a ~95% success rate and no serious safety signals in children treated for ADA‑SCID,...

Baby KJ case spurs pathway playbook for bespoke CRISPR therapies

November 01, 2025

Researchers behind the Philadelphia case known as 'Baby KJ' have published their FDA interactions and are publicly mapping a regulatory pathway to scale bespoke, patient‑specific CRISPR therapies....

Scalable human kidney organoids integrated into porcine kidneys ex vivo

November 01, 2025

Researchers at the Institute for Bioengineering of Catalonia and collaborators reported a scalable method to produce thousands of human kidney organoids and successfully integrate them into...

Cloud‑connected tubeless pump and CGM turbulence reshape diabetes device landscape

November 01, 2025

Real‑world data from over 14,000 users in France show that a tubeless insulin pump integrated with a cloud platform improved diabetes management metrics, according to a multicenter dataset. The...

mRNA’s promise tested: Moderna’s struggles and a surprise oncology signal

November 01, 2025

Moderna, once the poster child of mRNA therapeutics, is under pressure from falling COVID vaccine revenues, government contract cancellations and investor demands to reduce spending, according to...

Thermo Fisher upgrades mass‑spec and acquires Clario in data‑driven push

November 01, 2025

Thermo Fisher Scientific unveiled the Orbitrap Astral Zoom MS—an instrument that raises throughput and sensitivity for proteomics and metabolomics studies—and concurrently moved to deepen clinical...

AI accelerates drug discovery — open models and big‑tech breakthroughs

November 01, 2025

Academic groups and startups continue to push AI into core drug‑discovery tasks: MIT and Recursion released Boltz‑2 for rapid binding‑affinity prediction, and SandboxAQ and others are advancing...

Nanoparticle IL‑12 strategies revive ovarian cancer immunotherapy in preclinical models

November 01, 2025

MIT and collaborating teams reported polymer‑coated nanoparticles and other nanomaterials that deliver IL‑12 directly to ovarian tumor sites, enhancing responses to immune‑checkpoint inhibitors...

Metsera takeover battle: Pfizer sues, Novo counters with bigger bid

November 01, 2025

Pfizer filed a Delaware court suit accusing Novo Nordisk of improperly disrupting its agreed acquisition of obesity biotech Metsera and seeking a temporary restraining order. Pfizer alleges Novo’s...

FDA halts Intellia’s CRISPR trials after liver safety signals

November 01, 2025

The US Food and Drug Administration placed a clinical hold on Intellia’s two Phase 3 studies of nexiguran ziclumeran (nex‑z), a CRISPR-based in vivo gene‑editing candidate for transthyretin...

Synthetic biology scales: industry adopts engineering and AI tools

November 01, 2025

Biopharma companies are integrating synthetic biology to design novel modalities, optimize production and reach previously intractable targets. Companies like Mammoth Biosciences and others are...

From bench to one‑off cures: Baby KJ pushes FDA pathway for bespoke gene therapy

November 01, 2025

Researchers behind the bespoke CRISPR therapy for 'Baby KJ' published detailed FDA interactions and are engaging regulators to formalize a pathway for bespoke gene‑editing treatments. The team...

Organoids meet xenotransplantation: scalable human kidney organoids grafted in pigs

November 01, 2025

Researchers reported a scalable method to produce thousands of human kidney organoids and demonstrated their integration into porcine kidneys using ex vivo normothermic perfusion. Teams infused...

AI proposes drugs: Google model and open tools speed discovery

November 01, 2025

Google’s Cell2Sentence‑Scale foundation model (27B parameters) reportedly proposed and validated a cancer drug combination, marking an AI‑driven step in hypothesis generation for oncology....

Commercial push for heritable genome editing draws scrutiny

November 01, 2025

A new US company, Preventive, announced significant private funding to research heritable genome editing with the stated goal of assessing safety and responsible practice for editing embryos. The...

CAR‑T: clinical gains clash with commercial headwinds

November 01, 2025

A comparative study showed axicabtagene ciloleucel (axi‑cel) outperformed conventional first‑line therapy for high‑risk large B‑cell lymphoma, reinforcing clinical momentum for CAR‑T in earlier...