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Big pharma M&A for non-opioid pain
Eli Lilly agreed to acquire 4E Therapeutics to broaden its pain pipeline with an MNK inhibitor approach designed to avoid the opioid pathway. The Austin-based biotech’s lead candidate, 4ET1103, is...
FDA priority review vouchers and policy friction
A renewed debate has surfaced around the FDA’s Commissioner’s National Priority Review Voucher (CNPV) pilot, with experts urging a pause or reconsideration of the program’s details. Stakeholders...
Immunology deal: Biogen buys RayThera
Biogen is acquiring RayThera in a deal valued at up to $1 billion to add small-molecule immunology assets to its pipeline. The companies said Biogen will provide an undisclosed upfront payment,...
Clinical safety signal review in cancer bispecifics
A systematic review and meta-analysis estimated the frequency of second primary malignant neoplasms (SPMs) after T-cell-engaging bispecific antibody therapy in adult patients with B-cell...
Gene editing for Wilson’s disease enters clinic (regulatory clearance)
Prime Medicine cleared its Prime Editor program for clinical testing in Wilson’s disease after receiving clearance from Medsafe, New Zealand’s medicines regulator. The company’s investigational...
New biotech launch backed by Series A
Memento Medicines launched with a $93 million Series A financing and a licensed lead program aimed at retinal diseases. The company’s start emphasizes ophthalmology as an initial focus area and...
TB diagnostics rollout using Global Fund funding
The Global Fund and partners began rollout of 5,000 PlusLife MiniDock Ultra near point-of-care TB test systems across 13 countries supported by $50 million from the Children’s Investment Fund...
SSTR5 agonist preclinical for post-bariatric hypoglycemia
Confo Therapeutics presented preclinical characterization of CFTX-2034, a selective somatostatin receptor subtype 5 (SSTR5) agonist being developed for life-threatening post-bariatric hypoglycemia...
Genomics infrastructure for neurodegenerative disease
Germany’s DZNE launched NeuroGenomeHub, a new brain genomics initiative funded with about €6 million to build a global genome database for neurodegenerative diseases. The project aims to sequence...
Big Pharma M&A: Lilly expands pain pipeline with non-opioid mechanism
Eli Lilly agreed to acquire 4E Therapeutics, extending its push for non-opioid pain therapies at a time when the medical community remains focused on alternatives to opioid-based treatment. The...
Regulatory: FDA clears Diasorin rapid group A strep test for point-of-care PCR
The FDA granted 510(k) clearance and a CLIA waiver to Diasorin’s Liaison Nes rapid molecular group A strep test, giving clinicians a faster point-of-care option for acute pharyngitis. Diasorin...
Immunology M&A: Biogen buys RayThera to broaden small-molecule immunology portfolio
Biogen moved to strengthen its immunology pipeline by acquiring RayThera in a deal valued at up to $1 billion. The acquisition adds multiple anti-inflammatory small-molecule assets to Biogen’s...
Clinical evidence synthesis: Systematic review quantifies second malignancies after T-cell engaging bispecifics
A systematic review and meta-analysis estimated the frequency of second primary malignant neoplasms (SPMs) after T-cell-engaging bispecific antibody therapy in adults with non-Hodgkin lymphoma and...
Neuroscience platform/data: DZNE launches NeuroGenomeHub with €6M to build neurodegeneration genome resource
Germany’s DZNE launched NeuroGenomeHub, a brain genomics initiative funded with about €6 million to build a global genome database for neurodegenerative diseases. DZNE said the project will...
Gene editing regulation: Prime Medicine’s PM-577a cleared for clinical trial in Wilson’s disease
Prime Medicine received clearance from New Zealand’s Medsafe for the clinical trial application of PM-577a, an investigational Prime Editor for Wilson’s disease. The clearance advances the program...
Digital/diagnostics adoption: Norway deploys rapid nanopore sequencing for CNS tumor classification
Oxford Nanopore said Norway’s MATRIX program began rolling out rapid nanopore sequencing for central nervous system tumor classification across the country’s public healthcare infrastructure. The...
Company launch & funding: Memento Medicines raises $93M Series A for retinal disease pipeline
Memento Medicines launched with a $93 million Series A financing and secured licensing of a lead program for retinal diseases. The new ophthalmology-focused company is positioned to convert...
Funding/financing: Sophia Genetics raises $57.5M in upsized offering
Sophia Genetics closed an upsized underwritten public offering after strong investor demand, generating total gross proceeds of $57.5 million before underwriting discounts and commissions. The...
Data/health system: Global Fund starts PlusLife MiniDock Ultra TB test rollout in 13 countries
The Global Fund and partners began rolling out PlusLife MiniDock Ultra systems across 13 countries with $50 million in coordinated funding drawn from the Children’s Investment Fund Foundation. The...
Biogen acquisition expands immunology pipeline
Biogen moved to deepen its immunology pipeline by agreeing to acquire RayThera for up to $1 billion, adding early-stage small-molecule anti-inflammatory candidates alongside a lead asset expected...