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Moderna’s seasonal mRNA flu vaccine clears FDA advisory hurdle
An FDA vaccine advisory committee unanimously backed Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010 (Mflusiva), clearing a major regulatory milestone. VRBPAC voted 9-0 that...
Lilly expands non-opioid pain pipeline via acquisition of 4E Therapeutics
Eli Lilly agreed to buy 4E Therapeutics to strengthen its non-opioid pain program, adding a lead MNK inhibitor candidate (4ET1103) that entered human testing after completing a Phase 1 safety...
Biogen’s $1B immunology push: acquisition of RayThera
Biogen agreed to acquire RayThera in a deal valued at up to $1 billion, aiming to deepen its immunology pipeline with small-molecule anti-inflammatory assets. RayThera’s lead program is expected...
US–Germany trade probe into drug pricing systems
The US government launched a trade investigation into Germany’s drug pricing system amid the country’s review of health-care spending. The probe is filed under Section 301 of the Trade Act of...
Point-of-care sequencing rolls into Norway CNS tumor classification program
Oxford Nanopore said Norway’s MATRIX program, supported by regional health authorities and the Norwegian Cancer Society, has begun rolling out rapid nanopore sequencing for central nervous system...
Biotech platform financing: PlusLife Near Point-of-Care TB systems receive $50M rollout funding
The Global Fund and partners are coordinating a rollout of PlusLife MiniDock Ultra near point-of-care TB test systems across 13 countries using $50 million from the Children’s Investment Fund...
Genomics infrastructure: DZNE launches NeuroGenomeHub with €6M
The German Center for Neurodegenerative Diseases (DZNE) launched NeuroGenomeHub, a brain genomics initiative backed by approximately €6 million. The program aims to build a global genome database...
Regulatory expansion of AI-driven oncology testing: NCCN backs CSF profiling when biopsy isn’t feasible
NCCN updated its 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 use of...
Virology + therapeutics: AI-driven small-molecule hits against gonorrhea
Researchers at Harvard’s Wyss Institute used machine learning combined with classical screening to identify small molecules active against Neisseria gonorrhoeae in vagina-on-a-chip and mouse...
FDA regulatory decision—point-of-care infectious disease testing expansion
FDA has granted 510(k) clearance and a CLIA waiver for Diasorin’s Liaison Nes multiplex group A strep rapid molecular test, the company said. The assay is submitted on February and is designed to...
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...