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Regulatory: EMA CHMP positions for MS and dyslipidemia
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Sanofi’s BTK inhibitor Cenrifki (tolebrutinib) for secondary progressive multiple...
Deals: New takeover terms emerge for Seer
An investor group led by Bradley Radoff and Michael Torok raised its proposed Seer takeover price to $2.35 per share plus a contingent value right, according to an SEC filing referenced in the...
C-suite: Inventiva refreshes leadership ahead of Phase III readout
Inventiva added three executives to its C-suite as the French biotech prepares for a Phase III readout in 4Q26 for lanifibranor in metabolic dysfunction-associated steatohepatitis (MASH)....
Funding: Kurma closes €215M fund for disruptive therapeutics
Kurma Partners closed a €215M venture capital fund, described as its fourth and largest, targeting disruptive therapeutic solutions. The report notes prior Kurma exits including acquisitions of...
Clinical platform: Synthetic control arms gain momentum in trial design
A new data-driven approach is gaining traction in clinical development: synthetic control arms that use external datasets to generate comparator groups. The innovation spotlight described how...
Immunotherapy & engineered cells: Glycocalyx engineering for B-cell lymphoma ACT
A new study in Engineering outlines live-cell glycocalyx engineering strategies aimed at improving adoptive cell therapies (ACTs) for B-cell lymphoma. The work focuses on addressing recurring ACT...
Neuro/immune drug discovery: BBB-penetrant autophagy enhancers via AI screening
DeepDrugDiscovery unveiled an AI-driven screening platform designed to identify autophagy enhancers that can cross the blood-brain barrier and target Alzheimer’s disease pathology. The report...
Oncology biology: Epigenetic vulnerability in KMT2C/D loss
Research highlighted a set of actionable weaknesses created by loss of KMT2C and KMT2D, epigenetic regulators involved in tumor differentiation and fate control. The report ties the findings to...
Infectious disease: AI framework quantifies TB antibiotic resistance and predicts treatment response
Researchers introduced a convolutional neural network (CNN) approach intended to quantify antibiotic resistance in Mycobacterium tuberculosis and predict patient treatment responses. The report...
Diagnostics: Smart finger-cuff algorithm improves aortic stenosis case detection in Black patients
A REACH Trial report presented high accuracy for a smart finger cuff algorithm detecting moderate-to-severe aortic stenosis among African American patients. The work was presented at SCAI 2026...
Regulatory approvals in multiple sclerosis
Europe’s regulator moved to support Sanofi’s multiple sclerosis franchise after the U.S. FDA rejected the drug. The EMA’s CHMP recommended approval of Cenrifki (tolebrutinib) for non-relapsing...
FDA accelerates review of psychedelic mental health drugs
The FDA moved to speed up reviews for multiple psychedelic therapies targeting major depressive disorder, PTSD, and treatment-resistant depression. The agency will use priority review vouchers...
Biopharma financing and public-market momentum
Avalyn Pharma set out to raise capital for advanced development of inhaled respiratory therapies, signaling renewed public-market appetite for respiratory biotech. The company is targeting an IPO...
Large neuro dealmaking
UCB is buying epilepsy-focused Neurona Therapeutics for up to $1.15 billion, underscoring how aggressively big pharma is bidding for late preclinical-to-clinical neurologic assets. The transaction...
FDA setback for aneurysmal subarachnoid hemorrhage lead
Grace Therapeutics received an FDA complete response letter for its GTx-104 NDA, pausing plans to update the standard of care in aneurysmal subarachnoid hemorrhage. The agency cited manufacturing...
Synthetic control arms to reshape trial design
A data-driven approach to clinical trials is gaining attention as investigators look to reduce reliance on traditional placebo groups. Synthetic control arms use external datasets—such as...
Diagnostics: high-throughput risk assessment and biomarker platforms
New AI- and liquid-biopsy-adjacent tools are being positioned to improve cancer risk stratification and diagnostic throughput. City of Hope and UC Berkeley researchers reported a microfluidic...
Cell therapy and immune engineering advances
Researchers advanced next-generation immune cell engineering for solid tumors by reporting in vivo CAR-neutrophils designed for glioma treatment. The work addresses a long-standing technical...
New molecular biology tools and mechanistic insights
A set of cellular biology and molecular-engineering breakthroughs points to faster ways to see—and measure—complex biological systems. EPFL researchers developed CenSpark, a fluorescent probe that...
Funding and C-suite leadership reshuffles
Kurma Partners closed its fourth and largest venture fund, signaling continued institutional backing for therapeutic pipeline builders. The €215 million fund is raised to pursue disruptive...