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Congress paves Medicare path for MCED tests: FDA approval now key
The federal appropriations bill includes a provision that makes FDA‑approved multi‑cancer early detection (MCED) tests eligible for Medicare coverage, bypassing the longer USPSTF endorsement...
FDA asks to yank Tavneos; Amgen pushes back – Data dispute escalates
Regulatory scrutiny of Tavneos (avacopan) intensified after the FDA requested Amgen withdraw the drug amid questions over trial re‑adjudication and liver‑safety signals. Amgen publicly declined to...
BARDA offers $100M prize to speed broad‑spectrum antivirals
BARDA launched the first stage of a $100 million prize competition to incentivize development of broad‑spectrum, small‑molecule antivirals targeting Togaviridae and Flaviviridae families. The...
PharosAI taps 10x’s Xenium: NHS archives to power multimodal cancer AI
PharosAI, a U.K. research consortium, will use 10x Genomics’ Xenium spatial platform to build multiomic, spatially resolved cancer datasets from decades of archived NHS tumor samples. Supported by...
BC Platforms inks OmicsBank deal: 12M Indian patient records added
BC Platforms signed an agreement to integrate OmicsBank datasets into its BC Unify platform, gaining access to electronic medical records, pathology slides, images, sequencing data and...
Wearable aptamer patch reads drugs continuously – Pilot human trial
A pilot clinical trial published in Nature Biotechnology demonstrated an electrochemical, aptamer‑based wearable patch that measures drug concentrations continuously from interstitial fluid. The...
Generate:Biomedicines files for IPO — AI-designed antibody push
Generate:Biomedicines filed to go public, positioning an AI-driven antibody developer for Nasdaq capital markets as it advances multiple clinical-stage programs. The Flagship Pioneering–backed...
Eikon upsized IPO nets $381M — biggest biotech listing since 2024
Eikon Therapeutics priced an upsized Nasdaq IPO that raised $381 million, the largest biotech public offering since 2024, to fund clinical development of multiple oncology assets. The...
Veradermics prices $256M IPO — funds pivotal oral hair-loss trials
Veradermics priced an upsized $256.3 million IPO to finance three pivotal trials of VDPHL-01, an oral formulation of minoxidil for pattern hair loss. The company said the proceeds will support...
Pfizer’s monthly GLP-1 shows efficacy — Phase 3 program expands
Pfizer reported positive Phase 2 data from the Metsera-acquired monthly GLP-1, showing up to 12.3% placebo-adjusted weight loss at 28 weeks and tolerability comparable to peers. The company said...
Novo warns of 2026 sales drop — considers long-acting GLP-1 options
Novo Nordisk warned that 2026 sales will decline materially, citing pricing dynamics and competition in the obesity market, and its stock fell sharply following the guidance. Management pointed to...
BARDA and HHS launch $100M antiviral prize — broad-spectrum focus
BARDA announced the first stage of a $100 million prize competition to accelerate development of broad‑spectrum small-molecule antivirals targeting Togaviridae and Flaviviridae families. HHS...
Congress clears Medicare path for FDA‑approved MCED tests — coverage set
Congress approved an appropriations bill that includes a provision allowing Medicare coverage for FDA-approved multi-cancer early detection (MCED) tests, setting reimbursement equal to current...
AI in drug discovery and lab automation — Insilico selects candidate; Phylo raises seed
Insilico Medicine nominated ISM5059, a peripheral‑restricted NLRP3 inhibitor, as a preclinical candidate developed with generative AI, while Phylo raised $13.5 million to commercialize Biomni Lab,...
Next‑gen immune therapies advance — exhaustion reversal and safer IL‑12 variants
Preclinical work disclosed a first‑in‑class fusion protein able to reverse T‑cell exhaustion across multiple tumor models, while an alternative next‑generation IL‑12 program (STK‑026) surfaced...
CIRM commits $100M to platform gene‑therapy program for rare diseases
The California Institute for Regenerative Medicine (CIRM) launched the RAPID initiative, allocating $100 million over two years to support platform-based in vivo genetic therapies for rare...
Eikon Upsizes IPO to $381M — Biotech Lists with Cancer R&D War Chest
Eikon Therapeutics completed an upsized $381 million initial public offering, selling 21.2 million shares at $18 apiece to fund clinical development of its oncology pipeline. The California...
Veradermics Prices $256M IPO — Oral Rogaine Advances to Pivotal Trials
Veradermics priced an upsized $256.3 million IPO to finance pivotal phase II/III studies of VDPHL‑01, an oral formulation of minoxidil developed to avoid cardiovascular risks of prior systemic...
Pfizer’s Metsera GLP‑1 Posts Positive Data — Market Reaction Mixed
Pfizer released midstage data for PF‑08653944, the once‑monthly GLP‑1 acquired in its $10B Metsera deal, reporting placebo‑adjusted weight loss up to ~12.3% in one cohort and up to ~10.5% at six...
Congress Reauthorizes Pediatric PRV — Industry Wins; PBM Reforms Included
Congress extended the rare pediatric priority review voucher (PPRV/PRV) program through 2029 as part of a broader spending package that also included pharmacy benefit manager (PBM) transparency...