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Latest Biotech News

Gene‑therapy commercial strain: hemophilia pullbacks and regulatory setbacks

December 06, 2025

Commercial uptake and reimbursement challenges have pushed several hemophilia gene therapies into underperformance, product withdrawals and market reassessment, according to industry commentary...

Neutrophil atlas and EHR‑enhanced PRS sharpen genomics tools

December 06, 2025

An international consortium published NeuMap in Nature, presenting a single‑cell transcriptional atlas that maps neutrophil states across tissues and disease conditions and identifies functional...

Freenome jumps to public markets: $330M SPAC deal set

December 06, 2025

Freenome agreed to go public via a SPAC merger that will provide roughly $330 million of proceeds and a $240 million PIPE commitment from health-care investors. The company told investors the...

ACIP scraps universal hep B birth dose — guidance shifts

December 06, 2025

The CDC’s Advisory Committee on Immunization Practices voted to remove the universal recommendation that all newborns receive the hepatitis B vaccine at birth, instead advising parents to consult...

Praxis halts pivotal trial early — seizure drug posts striking efficacy

December 06, 2025

Praxis Precision Medicines stopped its registrational EMBOLD trial early after an interim analysis showed strong efficacy for relutrigine in genetic developmental and epileptic encephalopathies....

Bristol Myers expands Breyanzi label — first CAR‑T for marginal zone lymphoma

December 06, 2025

Bristol Myers Squibb secured regulatory approval to extend Breyanzi’s indication to include third‑line marginal zone lymphoma, making it the first CAR‑T therapy cleared for that rare non‑Hodgkin...

FDA churn: Høeg named CDER head as leadership reshuffle deepens

December 06, 2025

Tracey Beth Høeg, a physician and epidemiologist with prior public‑health commentary on vaccine policy, was named acting director of the FDA’s Center for Drug Evaluation and Research. The...

UniQure face‑plant: FDA signals tougher path for Huntington’s gene therapy

December 06, 2025

UniQure warned investors that the FDA’s feedback on its Huntington’s disease gene therapy indicates a longer, more difficult approval path than expected. Company minutes show agency staff raised...

Ginkgo wins $47M PNNL automation contract — phenotyping at scale

December 06, 2025

Ginkgo Bioworks secured a four‑year, $47 million contract to design and deliver an automated phenotyping platform for the Pacific Northwest National Laboratory’s Environmental Molecular Sciences...

Terray hits BMS milestone — AI‑driven discovery shows traction

December 06, 2025

Terray Therapeutics announced it achieved a discovery milestone under its multi‑target collaboration with Bristol Myers Squibb, marking the first disclosed success from its Experimentation Meets...

Triana raises $120M to advance molecular glue program

December 06, 2025

Triana Biomedicines closed an oversubscribed $120 million Series B to advance TRI‑611 and its molecular glue degrader platform toward clinical proof of concept. The financing was led by Ascenta...

Semaglutide fails to reduce CNS inflammation — Alzheimer’s readouts confirm

December 06, 2025

New data from phase 3 Evoke and Evoke+ trials showed oral semaglutide did not slow cognitive decline in Alzheimer’s disease, and translational studies reported the drug’s peripheral...

ACIP scraps universal hepatitis B birth dose: parents to consult clinicians

December 06, 2025

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to remove the universal recommendation that all newborns receive the hepatitis B vaccine immediately after birth. ACIP passed...

Makary ally Høeg named CDER chief – agency churn expected

December 06, 2025

Tracey Beth Høeg was named acting director of the FDA’s Center for Drug Evaluation and Research (CDER), marking another leadership change amid ongoing agency turmoil. Høeg, a physician and...

Praxis stops pivotal seizure study early – efficacy triggers readout

December 06, 2025

Praxis Precision Medicines halted its registrational-phase EMBOLD trial of relutrigine in developmental and epileptic encephalopathies after an interim analysis showed strong efficacy. The early...

Freenome moves to public markets via $330M SPAC – commercialization planned 2026

December 06, 2025

Freenome announced a merger with a SPAC that will provide roughly $330 million in gross proceeds, including a committed $240 million PIPE from institutional investors. The company plans to use the...

Triana closes $120M Series B to push molecular glue degrader into clinic

December 06, 2025

Triana Biomedicines closed an oversubscribed $120 million Series B to advance TRI-611, a molecular glue degrader targeting ALK-driven non–small cell lung cancer, toward clinical proof-of-concept....

Natera acquires Foresight to expand MRD sensitivity and lymphoma reach

December 06, 2025

Natera agreed to acquire Foresight Diagnostics for $275 million up front with up to $175 million in contingent payments tied to revenue and reimbursement milestones. The deal brings Foresight’s...

Ginkgo wins $47M DOE contract to automate high-throughput phenotyping at PNNL

December 06, 2025

Ginkgo Bioworks secured a four‑year, $47 million contract to design and integrate an automated phenotyping platform for Pacific Northwest National Laboratory (PNNL). The system will automate...

Terray hits BMS milestone – AI-backed discovery validates EMMI platform

December 06, 2025

Terray Therapeutics reported it reached a discovery milestone under its multi-target collaboration with Bristol Myers Squibb, demonstrating its Experimentation Meets Machine Intelligence (EMMI)...