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Latest Biotech News

Lilly becomes first drugmaker to hit $1 trillion — obesity portfolio drives surge

November 23, 2025

Eli Lilly reached a market valuation above $1 trillion after sustained gains tied to its obesity and metabolic medicines. The milestone marks the first time a pharmaceutical company has crossed...

FDA hiring surge: 1,000 reviewers plus a fast‑reply email channel

November 23, 2025

The FDA announced plans to hire more than 1,000 staffers and rolled out a pilot communications program to let sponsors email quick clarification questions to Office of New Drugs staff with...

Novartis plans North Carolina flagship hub — U.S. manufacturing push

November 23, 2025

Novartis announced plans to build a flagship manufacturing hub in North Carolina as part of a broader $23 billion U.S. investment. The program will add biologics and sterile‑packaging facilities...

GSK vs AnaptysBio — lawsuits flare over Jemperli licence and royalties

November 23, 2025

GSK (Tesaro) and AnaptysBio have moved into dual litigation in Delaware over a decade‑old licensing agreement for the cancer drug Jemperli. GSK sued first seeking termination of the deal and a...

Iambic: AI and automation compress chemistry‑to‑clinic to two years

November 23, 2025

San Diego‑based Iambic reported that physics‑informed algorithms plus lab automation are delivering small molecules through to clinic in roughly two years. The company combines AI‑driven design,...

Taiho, Cullinan file rolling NDA for zipalertinib — EGFR exon‑20 strategy

November 23, 2025

Taiho Pharmaceutical and Cullinan Therapeutics began filing a rolling NDA to the FDA for accelerated approval of zipalertinib, based on phase I/II data in NSCLC patients with EGFR exon 20...

Resalis ASO: Oligo therapy aims beyond appetite — targets fat metabolism

November 23, 2025

Resalis Therapeutics presented preclinical data on an antisense oligonucleotide (ASO) targeting miR‑22 that the company says drives durable, metabolically healthier weight loss in animal models....

Four biotechs raise nearly $950M in follow‑on offerings — market liquidity persists

November 23, 2025

Four public biotech companies — Nuvalent, Olema, Invivyd and Inhibikase — completed follow‑on offerings that collectively raised nearly $950 million. Companies used the market window to shore up...

Eli Lilly becomes first drugmaker to hit $1 trillion market value

November 22, 2025

Eli Lilly reached a historic market valuation after shares surged on sales tied to its obesity medicines. The company’s market cap briefly exceeded $1 trillion, a first for a pharmaceutical firm,...

Ginkgo Datapoints launches Virtual Cell Initiative – open standard for pharmacology modeling

November 22, 2025

Ginkgo Bioworks’ Datapoints unit launched the Virtual Cell Pharmacology Initiative (VCPI), an open‑source effort to standardize virtual cell modeling for drug discovery. Ginkgo said VCPI will...

Novartis to build flagship manufacturing hub in North Carolina: U.S. onshoring push

November 22, 2025

Novartis announced plans to create a flagship manufacturing hub in North Carolina as part of a $23 billion U.S. investment program. The project will add facilities for biologics, sterile...

FDA hires 1,000 staffers; pilots rapid-sponsor email channel

November 22, 2025

The U.S. Food and Drug Administration said it is hiring more than 1,000 employees and launched a pilot communications program meant to speed sponsor‑agency exchanges. The hiring push includes...

Ocean Diagnostics aims 2028 sepsis ID launch after pilot reports 100% concordance

November 22, 2025

France‑based Ocean Diagnostics reported a pilot clinical evaluation showing its rapid sepsis identification test matched conventional blood cultures at 100% concordance and correlated strongly...

Resalis presents antisense oligonucleotide targeting miR‑22… obesity approach beyond GLP‑1

November 22, 2025

Resalis Therapeutics presented preclinical data at TIDES showing an antisense oligonucleotide (ASO) that targets miR‑22, a microRNA implicated in metabolic regulation, produced durable weight‑loss...

Taiho and Cullinan file rolling NDA for zipalertinib – EGFR exon‑20 insertion NSCLC

November 22, 2025

Taiho Pharmaceutical and Cullinan Therapeutics began a rolling NDA submission to the U.S. FDA for zipalertinib, seeking accelerated approval for patients with locally advanced or metastatic NSCLC...

GSK and AnaptysBio clash over Jemperli licence; Anaptys launches $100M buyback

November 22, 2025

GSK’s Tesaro unit and AnaptysBio entered reciprocal litigation over a decade‑old license tied to the cancer drug Jemperli, with GSK seeking contract enforcement and Anaptys alleging breach by...

Contineum’s PIPE‑307 misses Phase 2 endpoints – shares plunge

November 22, 2025

Contineum Therapeutics reported topline Phase II VISTA results showing PIPE‑307 did not meet its primary or secondary efficacy endpoints in relapsing‑remitting multiple sclerosis (RRMS). The trial...

FDA opens probe into pediatric death possibly linked to Takeda’s Adzynma

November 22, 2025

The U.S. Food and Drug Administration said it is investigating the death of a pediatric patient that may be related to Takeda’s enzyme replacement therapy Adzynma. The agency flagged the event and...

Abbott to buy Exact Sciences: $21 billion play for cancer diagnostics

November 22, 2025

Abbott announced a definitive agreement to acquire Exact Sciences for approximately $21 billion, combining Abbott’s diagnostics scale with Exact Sciences’ cancer‑screening and precision oncology...

Eli Lilly reaches $1 trillion market value – obesity drugs drive surge

November 22, 2025

Eli Lilly became the first drugmaker to hit a $1 trillion market valuation after blockbuster performance from its obesity portfolio transformed the company’s revenue outlook. The milestone...