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Regulatory momentum for Moderna’s mRNA flu vaccine
An FDA advisory committee delivered unanimous support for Moderna’s mRNA-1010 influenza vaccine, advancing the product toward potential approval despite an earlier FDA review dispute. The Vaccines...
Lilly doubles down on non-opioid pain therapy via MNK inhibitors
Eli Lilly agreed to acquire 4E Therapeutics, aiming to expand its pain pipeline with a non-opioid approach built around MNK inhibitors. The purchase targets 4E’s MNK-eIF4E signaling pathway,...
FDA review policy under scrutiny: Commissioner’s National Priority Review Vouchers
Stakeholders questioned the FDA’s Commissioner’s National Priority Review Voucher (CNPV) pilot program, arguing it lacks key implementation details and may warrant pausing or cancellation. Experts...
FDA approvals: GSK-Spero oral antibiotic gains US nod for cUTI
GSK-Spero’s oral antibiotic tebipenem pivoxil hydrobromide, branded Utebzi, won US FDA approval for complicated urinary tract infections, including pyelonephritis. The approval arrives after the...
F2G moves to resubmit NDA for first novel antifungal in decades
F2G and Shionogi advanced an NDA resubmission effort for olorofim, positioning it for what could become the first new antifungal in more than 20 years. The companies said they now have the data...
Point-of-care strep testing expands on Diasorin’s Liaison Nes platform
Diasorin won FDA 510(k) clearance and a CLIA waiver for a multiplex group A streptococcus rapid molecular test on its Liaison Nes point-of-care PCR instrument. The company said the test delivers...
Wilson’s disease editing trial enters clinic for Prime Medicine
Prime Medicine’s Prime Editor PM-577a cleared regulatory requirements to begin clinical testing for Wilson’s disease. The company said the New Zealand authority Medsafe approved its clinical trial...
New funding for ophthalmology startup Memento Medicines
Memento Medicines launched with a focus on ophthalmology and secured a $93 million Series A financing tied to licensing a lead program for retinal diseases. The company’s launch structure centers...
Point-of-care tuberculosis diagnostics scale-up begins with global funding
The Global Fund and partners began rolling out PlusLife MiniDock Ultra near point-of-care TB test systems across 13 countries using $50 million from the Children’s Investment Fund Foundation. The...
Big pharma M&A expands immunology pipelines
Biogen agreed to buy RayThera in a deal valued at up to $1 billion, aiming to deepen its immunology pipeline with early-stage small-molecule assets. The acquisition gives Biogen a portfolio of...
Regulatory action: point-of-care infectious disease testing expands
FDA cleared Diasorin’s Liaison Nes multiplex group A strep molecular test and granted a CLIA waiver for point-of-care use. The test is designed to deliver results in about 15 minutes with less...
FDA advisory panel backs Moderna’s seasonal mRNA flu vaccine
FDA vaccine advisers unanimously endorsed Moderna’s mRNA-1010, voting that benefits outweigh risks for adults ages 50–64 and separately for those 65 and older. The Vaccines and Related Biological...
New clinical option in oncology diagnostics: CSF profiling when biopsy isn’t feasible
NCCN updated guidelines to recommend CSF-based molecular tumor profiling for patients with high-grade glioma or glioblastoma when tissue biopsy is not feasible. The update supports CSF testing as...
New oncology trial entry: gene editor gets go-ahead for clinic in Wilson’s disease
Prime Medicine’s investigational Prime Editor PM-577a cleared for clinical testing in New Zealand after Medsafe accepted the company’s clinical trial application. The therapy targets Wilson’s...
Regulatory clearance for antibacterial therapy after a prior CRL
GSK-Spero’s oral antibiotic Utebzi (tebipenem pivoxil hydrobromide) won FDA approval for complicated urinary tract infections, including pyelonephritis. The approval comes about four years after...
Gene-by-gene platform expansion: Beam Therapeutics gets IND for PKU base editing
Beam Therapeutics received FDA IND clearance for BEAM-304, a liver-targeting lipid nanoparticle delivery of base editing reagents for phenylketonuria. The program is designed to correct PAH...
Clinical-stage milestone: oncology oral antifungal resubmission path advances
F2G, with Shionogi, said it has completed the data package needed to resubmit an NDA for orally administered olorofim. The company reported positive Phase III results showing noninferiority to...
Immunology M&A and platform dealmaking: new payments and pipeline focus
Lilly moved to expand its non-opioid pain pipeline by acquiring 4E Therapeutics, a biotech developing MNK inhibitors for pain without the central nervous system effects tied to opioids. The deal...
AI acceleration for regulated biopharma submissions
IDBS and Alchemi partnered to accelerate AI-driven preparation of biopharma regulatory filings, linking AI agents to the IDBS Polar governed data backbone. The companies said the approach is...
Regulatory clearance for rapid point-of-care group A strep testing
Diasorin said FDA has granted 510(k) clearance and a CLIA waiver for its Liaison Nes Group A Strep rapid molecular test. The assay targets acute pharyngitis, delivering results in about 15 minutes...