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Latest Biotech News

Ginkgo Datapoints launches Virtual Cell Initiative... 12 billion data-point goal

November 22, 2025

Ginkgo Bioworks’ Datapoints unit unveiled the Virtual Cell Pharmacology Initiative (VCPI), an open-source effort to build a standardized pharmacology dataset and reference engineered cell line...

Ocean Diagnostics’ rapid sepsis test matches culture results 100%

November 22, 2025

France-based Ocean Diagnostics completed a pilot clinical evaluation showing its rapid bloodstream pathogen identification test matched gold‑standard blood cultures at 100% in a prospective ICU...

Novartis to build flagship US manufacturing hub — North Carolina expansion

November 22, 2025

Novartis announced plans to construct a flagship manufacturing hub in North Carolina as part of a $23 billion U.S. infrastructure investment over five years. The project will add biologics...

Industry pushes for FDA stability as Makary aide stays amid White House fracas

November 22, 2025

Hundreds of biotech CEOs delivered a letter to FDA Director Marty Makary warning that regulatory unpredictability threatens innovation; the group cited survey evidence that 82% of respondents were...

Contineum’s PIPE‑307 misses Phase II vision endpoints — shares tumble

November 22, 2025

Contineum Therapeutics reported topline results from its Phase II VISTA trial of PIPE‑307, an M1 receptor antagonist developed with Janssen, and the study failed to meet its primary and secondary...

Hepta publishes cfDNA methylation proof‑of‑concept for liver disease

November 22, 2025

Hepta released proof‑of‑concept data indicating cell‑free DNA methylation signatures in plasma reflect liver biology, including fibrosis and cell‑type composition, based on an atlas assembled with...

Cassidy Bio raises $8M seed to scale AI platform for gene‑editing design

November 22, 2025

Tel Aviv‑based Cassidy Bio closed an $8 million seed round led by Ahren Innovation Capital to develop an AI platform that predicts optimal combinations of guide RNAs, editing enzymes and delivery...

Aspen closes $115M Series C to advance personalized Parkinson’s cell therapy

November 22, 2025

Aspen Neuroscience secured $115 million in Series C financing to support its autologous cell therapy program for Parkinson’s disease, expand manufacturing capacity and progress an ongoing clinical...

Abbott to buy Exact Sciences: $105-a-share deal reshapes cancer-diagnostics market

November 21, 2025

Abbott announced a definitive agreement to acquire Exact Sciences for $105 per share, a transaction valued at roughly $21 billion in equity and about $23 billion on an enterprise basis in some...

FDA clears Bayer’s Hyrnuo: new HER2 therapy and companion test land

November 21, 2025

The U.S. Food and Drug Administration approved Bayer’s oral HER2‑directed drug Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non‑squamous NSCLC harboring activating HER2...

Pfizer’s mRNA flu shot... Phase 3 shows 34.5% efficacy advantage

November 21, 2025

Pfizer released full Phase 3 data showing its experimental mRNA influenza vaccine candidate delivered a 34.5% greater protective efficacy than a standard control vaccine in the trial cohort. The...

Novartis builds flagship US hub: North Carolina chosen for end‑to‑end manufacturing

November 21, 2025

Novartis announced plans to build a flagship manufacturing hub across its North Carolina sites, adding new biologics, sterile packaging and solid‑dose facilities in Durham and Morrisville. The...

FDA hires 1,000+ and pilots email clarifications to speed drug reviews

November 21, 2025

The FDA announced plans to add more than 1,000 staffers and launched a pilot communications program that allows sponsors to submit one brief email clarification to Office of New Drugs review staff...

Lilly hits $1 trillion: obesity drugs drive pharma’s first trillion‑dollar market cap

November 21, 2025

Eli Lilly briefly became the first pharmaceutical company to reach a $1 trillion market capitalization, a milestone driven by blockbuster growth in its obesity and diabetes portfolio. The intraday...

Big pharma shifts: Novo and Lilly sell obesity drugs directly to employers — Waltz Health launches program

November 21, 2025

Novo Nordisk and Eli Lilly are setting up direct contracting channels with self‑insured employers to offer high‑cost obesity medications, bypassing some traditional distribution and PBM pathways....

CDC vaccine guidance reversal... public trust shaken as uptake falls

November 21, 2025

The Centers for Disease Control and Prevention quietly revised language on a vaccine safety web page to state that the claim 'vaccines do not cause autism' cannot be ruled as evidence‑based, a...

Ocean Diagnostics’ rapid sepsis test... pilot matched cultures and eyes FDA path

November 21, 2025

France‑based Ocean Diagnostics reported that a one‑year pilot study at Bordeaux University Hospital showed its rapid sepsis identification test matched all bloodstream infections detected by...

Cassidy Bio raises $8M seed... AI platform for designing gene‑editing therapies

November 21, 2025

Tel Aviv‑based Cassidy Bio closed an $8 million seed round led by Ahren Innovation Capital to develop an AI platform that predicts optimal combinations of guide RNAs, editing enzymes and delivery...

Abbott buys Exact Sciences: $21 billion leap into cancer diagnostics

November 21, 2025

Abbott announced a definitive agreement to acquire Exact Sciences for approximately $21 billion in cash, expanding Abbott’s diagnostics footprint into cancer screening and precision oncology....

Bayer’s HER2 drug gets FDA nod — Thermo Fisher supplies companion test

November 21, 2025

The FDA granted accelerated approval to Bayer’s oral HER2-directed therapy Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non-small-cell lung cancer bearing activating HER2...