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Latest Biotech News

Apalutamide vs enzalutamide: survival debate — comparative letters and analyses

November 30, 2025

Recent correspondence and analyses revisited survival outcomes comparing apalutamide and enzalutamide in metastatic castration‑sensitive prostate cancer (mCSPC). A primary report examined...

FDA proposes plausible-mechanism pathway: expedited route for bespoke rare therapies

November 30, 2025

US regulators and academics published a proposed “plausible mechanism” pathway to accelerate access to bespoke medicines for ultra-rare conditions. Vinay Prasad and Martin Makary (FDA authors)...

Off-the-shelf mRNA vaccines: new immunotherapy approach for liver cancer

November 30, 2025

Researchers reported development of off‑the‑shelf mRNA vaccines targeting hepatocellular carcinoma (HCC) that elicit tumor-directed immune responses in preclinical models. The work outlines...

Bird flu tolerates fever: PB1 gene enables high-temperature replication

November 30, 2025

Researchers identified the viral PB1 gene as the determinant allowing avian influenza strains to replicate at fever-range temperatures that suppress human-origin viruses. Mouse experiments...

mRNA engineering boosts allogeneic stem cells: DC‑25 shows immunotherapy promise

November 30, 2025

Scientists engineered mesenchymal stromal cells (MSCs) with synthetic mRNA to produce an allogeneic cell therapy dubbed DC‑25 that enhances immune-modulatory signals and resists host rejection....

Drugmakers expand small-molecule arsenals – Kymera’s STAT6 and Schrödinger’s mutant EGFR

November 30, 2025

Two patent disclosures signaled fresh small-molecule efforts in oncology and immune disorders: Kymera filed STAT6 inhibitors intended for cancer and inflammatory diseases, while Schrödinger...

Boehringer discovers cGAS inhibitors: new candidates for interferon-driven diseases

November 30, 2025

Boehringer Ingelheim reported discovery of small-molecule cGAS inhibitors with potential applications across autoinflammatory interferonopathies, idiopathic pulmonary fibrosis,...

Targeting cell-death pathways: Cathepsin L and sibiriline offer dual benefits for cancer and degeneration

November 30, 2025

Two independent preclinical advances map therapeutic routes through regulated cell-death pathways. A Nature Communications study identified Cathepsin L as a dual target that suppresses tumor...

Kedrion wins EU orphan designation for aceruloplasminemia: plasma-derived therapy advances

November 30, 2025

Kedrion SpA announced European Medicines Agency orphan-drug designation for its investigational plasma-derived therapy to treat congenital aceruloplasminemia. The designation aims to facilitate...

Single 2‑ml mirikizumab injection bioequivalent to two 1‑ml doses: administration simplified

November 30, 2025

A clinical pharmacology study led by Otani, Payne and Loftus showed a single 2‑ml subcutaneous injection of mirikizumab is bioequivalent to two separate 1‑ml injections in healthy volunteers. The...

Biotech funding lifelines: investors press maturity, seek alternative financing

November 30, 2025

Industry leaders at an LSX Investival panel urged biotechs to raise scientific maturity and clinical validation before seeking large investment rounds. Speakers from Blackstone, Limerston Capital...

FDA’s plausible‑mechanism pathway: proposal to speed bespoke rare‑disease approvals

November 29, 2025

The FDA and authors including CBER director Vinay Prasad and Martin Makary published a ‘‘plausible mechanism’’ pathway in the New England Journal of Medicine proposing a streamlined route to...

mRNA boosts off‑the‑shelf MSC therapy: DC‑25 emerges

November 29, 2025

Researchers reported engineering allogeneic mesenchymal stem cells (MSCs) with mRNA to enhance immunomodulatory properties and created a candidate called DC‑25 that aims to overcome limitations of...

Off‑the‑shelf mRNA cancer vaccines: new candidates target liver tumors

November 29, 2025

A team published preclinical data on off‑the‑shelf mRNA vaccines designed to target hepatocellular carcinoma (HCC), reporting antigen selection and immune responses supportive of further...

VT‑3989 halts NF2‑deficient tumor growth: Vivace posts preclinical efficacy

November 29, 2025

Vivace Therapeutics disclosed preclinical efficacy for VT‑3989, a TEAD inhibitor that suppressed growth of NF2‑deficient meningioma models in vitro and in vivo. Company data show tumor growth...

M‑3554 ADC shows activity in soft‑tissue sarcoma models – developer reports

November 29, 2025

Preclinical results for M‑3554, an antibody‑drug conjugate (ADC) targeting GD2 with a β‑glucuronide linker and exatecan payload, demonstrate potent antitumor activity in neuroblastoma and...

Kymera patents STAT6 inhibitors: new small‑molecule program disclosed

November 29, 2025

Kymera Therapeutics filed patents disclosing STAT6 inhibitors as small‑molecule therapeutics with indications spanning cancer, inflammatory and metabolic diseases. The disclosure outlines chemical...

Boehringer unveils cGAS inhibitors: candidates for fibrotic and autoimmune disease

November 29, 2025

Boehringer Ingelheim disclosed discovery of cGAS inhibitors aimed at autoinflammatory interferonopathies, pulmonary fibrosis, MASH, systemic sclerosis and lupus. The disclosure describes chemical...

Eli Lilly files RXFP1 agonists: relaxin‑receptor program surfaces

November 29, 2025

Eli Lilly published chemical series of RXFP1 (relaxin receptor 1) agonists mapped to potential indications including pulmonary hypertension, kidney disease and diabetic nephropathy. The disclosure...

Telix shareholders urged to contact Robbins LLP: TLX class action notice

November 29, 2025

A legal notice from Robbins LLP announced a proposed class action related to Telix Pharmaceuticals (NASDAQ: TLX), advising shareholders with significant losses during the specified class period to...