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FDA advisory committee backs Moderna’s mRNA flu vaccine
Moderna’s mRNA influenza vaccine mRNA-1010 moved back into regulators’ favor as FDA vaccine advisers voted unanimously that benefits outweigh risks. The Vaccines and Related Biological Products...
FDA clears Diasorin’s point-of-care group A strep molecular test
Diasorin received US FDA clearance and a CLIA waiver for a multiplex group A streptococcus assay on its Liaison Nes point-of-care PCR instrument. The Liaison Nes Group A Strep test is designed to...
Biogen buys RayThera to expand immunology small-molecule pipeline
Biogen agreed to acquire RayThera in a deal valued at up to $1 billion, adding a portfolio of early-stage immunology assets to the company’s pipeline. RayThera’s co-founders built a small-molecule...
Confo Therapeutics advances SSTR5 agonist CFTX-2034 for PBH
Confo Therapeutics presented preclinical characterization of CFTX-2034, a selective somatostatin receptor subtype 5 (SSTR5) agonist targeting life-threatening hypoglycemic episodes in...
Prime Medicine gets Medsafe clearance to begin Wilson’s trial
Prime Medicine obtained regulatory clearance from New Zealand’s Medsafe for its clinical trial application for PM-577a, a Prime Editor program targeting Wilson’s disease. The clearance advances...
Oxford Nanopore pushes rapid CNS tumor classification rollout in Norway
Oxford Nanopore expanded clinical adoption of rapid nanopore sequencing for CNS tumor classification through Norway’s MATRIX program and the country’s national precision diagnostics infrastructure...
F2G and Shionogi secure Phase III proof for oral antifungal olorofim
F2G and Shionogi released positive Phase III results for olorofim, an orally administered antifungal developed as a potential alternative to intravenous Ambisome for refractory aspergillosis. The...
Novo Nordisk invests in Czech and China footprint; Cellares raises Series D
Novo Nordisk is expanding manufacturing capacity through investments totaling about $380 million to grow its facility in Bohumil, Central Bohemia, in the Czech Republic. The update adds to...
AI + governance for regulatory filings: IDBS partners with Alchemi
IDBS and Alchemi partnered to accelerate AI-driven regulatory filings by connecting AI agents to IDBS Polar’s governed data foundation across the drug development lifecycle. The collaboration...
Pain pipeline consolidation at Eli Lilly via non-opioid MNK inhibition
Eli Lilly agreed to buy 4E Therapeutics, extending its focus on non-opioid pain medicines after prior acquisitions in the space, including the May 2025 purchase of SiteOne. The deal centers on...
FDA advisory committee backs Moderna’s mRNA flu vaccine for licensure path
FDA vaccine advisers on Wednesday unanimously endorsed Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010, setting the stage for an FDA decision on licensure. The Vaccines and Related...
Regulatory flexibility signal for gene therapy: uniQure’s accelerated BLA plan advances
uniQure reported another reversal in its Huntington’s disease gene-therapy pathway after the U.S. FDA indicated that three-year analysis data from the Phase I/II study would be acceptable for an...
Global oncology diagnostics rollout: rapid nanopore sequencing enters Norway public system
Oxford Nanopore said Norway’s MATRIX program, operated through the Norwegian Centre for Clinical Cancer Research, has started rolling out rapid nanopore sequencing for central nervous system tumor...
Biogen doubles down on immunology with up-to-$1B RayThera buyout
Biogen agreed to acquire RayThera in a deal valued at up to $1 billion, aiming to expand its immunology pipeline with early-stage anti-inflammatory candidates. RayThera’s lead asset is expected...
Biotech funding: Memento Medicines launches with Series A backing and retinal drug licensing
Memento Medicines launched with a $93 million Series A financing and licensing of a lead program focused on retinal diseases. The company’s initial pipeline emphasis on ophthalmology points to a...
Precision genome testing: NCCN adds CSF-based molecular profiling for biopsy-infeasible gliomas
The National Comprehensive Cancer Network (NCCN) updated guidelines to recommend cerebrospinal fluid (CSF)-based molecular tumor profiling for patients with high-grade glioma and glioblastoma when...
Bioprocessing funding: cAMPfield raises $180M Series A for oral IBD PDE4B inhibitor prifemilast
cAMPfield Therapeutics launched with a $180 million Series A to develop prifemilast, an oral PDE4B-selective inhibitor positioned as a potential alternative to biologics in inflammatory bowel...
IFD-to-clinic diagnostics and pharma filings: IDBS and Alchemi connect agent drafting to governed CMC data
IDBS partnered with Alchemi to connect AI agents to drug-development data inside the IDBS Polar platform, targeting faster and compliant preparation of regulatory filings. The collaboration is...
Biotech IPO market: Kardigan upsized $400M offering to fund root-cause heart therapies toward Phase 3
Kardigan priced an upsized biopharma IPO to raise about $400 million gross, positioning three mid-stage cardiovascular programs focused on addressing root causes of heart disease. The company...
Immunology dealmaking: Biogen buys early-stage assets
Biogen struck a deal to acquire RayThera in a transaction valued at up to $1 billion, aiming to deepen its immunology pipeline with anti-inflammatory small-molecule candidates. The acquisition,...