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Beacon Biosignals raises $86M to build global brain‑wave dataset

November 13, 2025

Beacon Biosignals secured $86 million in funding to assemble a large, standardized EEG dataset aimed at powering diagnostics and drug development in neurology and psychiatry. The company will...

Evotec earns IND milestone from BMS protein‑degradation pact

November 13, 2025

Evotec announced a milestone payment after Bristol Myers Squibb accepted an IND derived from their strategic protein‑degradation alliance. The $5 million milestone reflects progress in a...

Metagenomi pivots — 25% layoffs while hemophilia program posts NHP success

November 13, 2025

Gene‑editing heavyweight Metagenomi cut roughly 25% of its workforce — including the CEO — as it refocuses on a preclinical hemophilia A program, the company said in a corporate restructuring...

FDA unveils plausible-mechanism path: roadmap for bespoke rare-disease therapies

November 13, 2025

The FDA sketched a new regulatory approach—the “plausible mechanism” pathway—intended to accelerate approvals for individualized and ultra-rare therapies. Agency officials and authors published...

Novartis’ GanLum meets WHO bar: Phase 3 shows high cure rates

November 13, 2025

Novartis reported Phase 3 results showing its combination therapy GanLum (ganaplacide plus lumefantrine) was non-inferior to standard of care in 1,688 patients across sub-Saharan African sites and...

Pazdur to lead CDER — FDA picks cancer regulator to steady drug reviews

November 13, 2025

The FDA appointed longtime oncology chief Richard Pazdur as director of the Center for Drug Evaluation and Research, a move the agency framed as stabilizing amid recent leadership turnover....

Metagenomi sheds staff and refocuses — CEO exits amid hemophilia pivot

November 13, 2025

Gene-editing company Metagenomi announced a workforce reduction of roughly 25% and leadership departures, including its CEO, as the firm reorients toward a preclinical hemophilia A program. The...

Nilo launches with $101m: neuro-immunology startup targets brain–immune circuits

November 13, 2025

Nilo Therapeutics launched with a $101 million Series A to develop therapies that modulate neural circuits to restore immune homeostasis. The New York-based company, founded by neuroscientists and...

Beacon Biosignals raises $86m to build brain dataset for neurology R&D

November 13, 2025

Beacon Biosignals closed an $86 million financing to assemble a large brain‑wave dataset intended to accelerate drug and diagnostic development for neurological disorders. The company plans to...

TRIM25 and VISTA workpoints suggest new immune-checkpoint strategies

November 13, 2025

Two preclinical studies identified actionable nodes to amplify cancer immunotherapy. One report showed that loss of the E3 ligase TRIM25 enhances T-cell anti‑tumor activity through modulation of...

Early-detection tools advance: Mayo predictive model and gentler methylation sequencing

November 13, 2025

Mayo Clinic researchers unveiled a predictive model that estimates Alzheimer’s risk years before clinical symptoms using decades of clinic data; the model appears to stratify individuals for...

Gene therapy for bladder cancer delivers: Engene posts pivotal data, eyes 2026 filing

November 13, 2025

Engene/EnGene disclosed additional pivotal‑cohort data for its nonviral gene therapy detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in...

Stanford links EBV to lupus: virus shown to reprogram immune B cells

November 13, 2025

Researchers at Stanford published evidence connecting Epstein‑Barr virus infection to the development of systemic lupus erythematosus. The study demonstrated that EBV can reprogram B cells to...

Novartis’ GanLum passes Phase 3 — poised to tackle artemisinin resistance

November 13, 2025

Novartis reported Phase 3 results showing GanLum (ganaplacide + lumefantrine) achieved non‑inferiority to current standard therapy and cleared World Health Organization efficacy thresholds in...

FDA taps Richard Pazdur: Oncology veteran named CDER director

November 13, 2025

The FDA named Richard Pazdur to lead the Center for Drug Evaluation and Research (CDER), moving its long‑time oncology chief into the agency’s top drug regulator role. Pazdur’s appointment follows...

FDA unveils plausible‑mechanism path... bespoke gene edits could speed approvals

November 13, 2025

Top FDA officials and agency commentators outlined a new regulatory roadmap—often called the “plausible‑mechanism” pathway—intended to accelerate approvals for bespoke, patient‑specific therapies....

GLP‑1s go mainstream: Medicare, sales reshape obesity market

November 13, 2025

Analyses indicate GLP‑1 receptor agonists are shifting from specialty to mass‑market drugs. Medicare policy changes and potential coverage expansions are expected to reduce patient prices while...

CRISPR’s split week — clinical death and technical wins roil field

November 13, 2025

The CRISPR sector faced contrasting developments: Intellia reported a fatality and an FDA clinical‑hold risk in its MAGNITUDE Phase III program after a patient developed severe liver injury,...

Neuro‑immunology gets a $101M lift: startups build neural‑immune modality stacks

November 13, 2025

Nilo Therapeutics launched with a $101 million Series A to translate neuro‑immunology discoveries into therapies that modulate brain‑body circuits to restore immune homeostasis. Backers include...

VISTA emerges as checkpoint target: TRIM25 link boosts immunotherapy

November 13, 2025

Multiple preclinical studies strengthened VISTA’s candidacy as an immune‑checkpoint target. One paper shows that loss of TRIM25 enhances anti‑tumor immunity by modulating VISTA pathways in T...