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Big Pharma M&A—Lilly adds non-opioid pain platform via MNK inhibitors
Eli Lilly has agreed to acquire 4E Therapeutics, expanding its pain portfolio with an approach designed to avoid the central nervous system risks of opioids. The acquisition targets 4E’s MNK...
Immunology portfolio build—Biogen buys RayThera for up-to-$1B
Biogen is buying RayThera in a deal valued at up to $1 billion to add early-stage immunology assets to its pipeline, the companies said. RayThera’s lead candidate is positioned to enter Phase I in...
Regulatory and panel review—Moderna’s mRNA influenza vaccine clears FDA advisory committee
FDA vaccine advisers have voted unanimously in favor of Moderna’s seasonal mRNA-1010 influenza vaccine, clearing a key hurdle as the company seeks to expand its mRNA platform to the flu market....
New antibiotic approval—oral carbapenem-based therapy for complicated UTI
The FDA has approved Spero Therapeutics’ oral antibiotic tebipenem pivoxil hydrobromide (Branded as Utebzi) for complicated urinary tract infections, including pyelonephritis, following years of...
Oncology diagnostics—NCCN adds CSF-based molecular profiling when biopsy isn’t feasible
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...
Regulatory move—IND clearance for Prime Medicine’s PM-577a in Wilson’s disease
Prime Medicine has received clearance from New Zealand’s Medsafe for its clinical trial application for PM-577a, an investigational Prime Editor for Wilson’s disease. The clearance advances the...
Rare disease therapy—Cenna’s 8M2D gets IND clearance for Alzheimer’s peptide program
Cenna Biosciences has obtained IND clearance from the FDA for 8M2D, a first-in-class peptide candidate for the treatment of Alzheimer’s disease. The company said a Phase Ia/Ib trial in healthy...
Clinical/biopharma financing—Biotech IPO market continues with Kardigan upsized $400M offering
Kardigan Inc. has priced an upsized biopharma IPO to raise about $400 million gross, following strong demand that pushed the deal to the top end of its range. The cardiovascular-focused company is...
Funding—cAMPfield launches with $180M Series A for oral IBD PDE4B inhibitor
cAMPfield Therapeutics launched with $180 million in a Series A to develop prifemilast, an oral PDE4 inhibitor positioned as a potential alternative to injectable biologics for inflammatory bowel...
FDA/Regulatory policy and expedited review mechanisms
The FDA’s Commissioner’s National Priority Review Voucher (CNPV) pilot program is drawing renewed scrutiny as stakeholders argue the program lacks key operational details and could be redundant to...
Moderna’s mRNA flu vaccine regulatory path clears FDA advisory committee
An FDA advisory panel voted unanimously to support Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010, advancing the product’s regulatory turnaround. The Vaccines and Related...
Biopharma M&A: Biogen buys immunology startup RayThera for up to $1B
Biogen agreed to acquire RayThera in a deal valued at up to $1 billion, adding a suite of early-stage immunology-focused small-molecule candidates to its pipeline. RayThera’s investors will...
Antibiotics/anti-infectives: GSK-Spero oral antibiotic wins FDA approval for cUTI
The FDA approved Spero Therapeutics’ oral carbapenem antibiotic tebipenem pivoxil hydrobromide (branded Utebzi) for complicated urinary tract infections, including pyelonephritis. The approval...
Precision diagnostics: Diasorin obtains FDA clearance and CLIA waiver for rapid Group A Strep test
Diasorin received FDA 510(k) clearance and a CLIA waiver for a Group A streptococcus rapid molecular test on its Liaison Nes point-of-care PCR instrument. Diasorin said the assay delivers results...
FDA review and biodevice/clinical-genomics adoption: rapid nanopore CNS tumor classification rollout in Norway
Oxford Nanopore said Norway’s MATRIX program has begun rolling out a rapid nanopore sequencing assay for central nervous system (CNS) tumor classification across the country’s public healthcare...
Oncology pipeline: ADC Therapeutics Zynlonta faces trial-related fatal safety signal
ADC Therapeutics reported a stumbling block for its antibody-drug conjugate Zynlonta (loncastuximab tesirine) after Phase III results from LOTIS-5 showed higher fatal adverse events in the...
Biotech financing and go-to-clinic momentum: Prime Medicine gets NZ clearance for Wilson’s disease trial
Prime Medicine said New Zealand’s Medsafe cleared its clinical trial application for PM-577a, a Prime Editor for Wilson’s disease. The company positioned PM-577a as investigational and designed...
Regional regulatory frameworks for advanced therapies: China’s Order 818 opens a hospital-based pathway
China issued Order 818 establishing a new commercialization pathway for advanced therapeutic development, including cell and gene therapeutics and gene editing approaches. The regulation allows...
Biotech IPO/market access: Kardigan prices and upsizes $400M offering
Cardiovascular biotech Kardigan priced an upsized IPO to raise $400 million gross proceeds, following strong market demand for new listings. The company is offering 25 million shares at $16 per...
FDA OKs oral antibiotic Utebzi for complicated UTI
Spero Therapeutics’ oral carbapenem antibiotic tebipenem pivoxil hydrobromide, branded as Utebzi, has received US FDA approval for complicated urinary tract infections (cUTI), including...