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FDA Asks Amgen to Withdraw Tavneos — Amgen Declines, Regulatory Fight Looms
The FDA has asked Amgen to withdraw Tavneos (avacopan) from the US market while revisiting data‑adjudication issues from the drug’s pivotal trial; Amgen has publicly refused and said it will...
BARDA Launches $100M Antiviral Prize — Norovirus Culture Breakthrough Follows
BARDA unveiled the first stage of a $100 million prize competition to spur broad‑spectrum small‑molecule antivirals against Togaviridae and Flaviviridae, aiming to accelerate preclinical and...
Wearable Drug‑Monitoring Patch Validated in Pilot — Continuous TDM Enters Clinic
A pilot clinical trial published in Nature Biotechnology demonstrated a wearable, electrochemical aptamer‑based patch that continuously measures drug concentrations from interstitial fluid in...
AI Meets Regenerative Medicine — Foundation Models and Phylo’s $13.5M Seed
Researchers and startups are applying foundation models to reduce variability in stem‑cell derived therapeutics while investors back AI‑native lab platforms. An AI foundation model targeting...
Platform Strategy for Rare Genetic Therapies: CIRM $100M RAPID and PrimeGen SPAC Move
The California Institute for Regenerative Medicine approved a $100 million RAPID program to fund platform‑based in‑vivo genetic therapies for rare diseases, shifting from single‑asset funding...
Genetic and Cellular Routes to Stronger Immunotherapy — New T‑cell and NKT Findings
A Nature study identified two genes that govern CD8+ T‑cell fate and suggest levers to boost killer T‑cell durability and function in cancer, while UCLA researchers reported an engineered...
Eikon Therapeutics Prices $381M IPO: Mapping Proteins to Markets
Eikon Therapeutics sold 21+ million shares at $18 apiece to secure $381 million in an initial public offering, marking one of the largest biotech listings this week. The San Francisco–area company...
Veradermics Upsizes IPO to $256M: Oral Minoxidil Trials Funded
Veradermics priced an upsized initial public offering that raised roughly $256 million to fund three pivotal trials of VDPHL‑01, an oral formulation of minoxidil for pattern hair loss. The company...
Pfizer’s Monthly GLP‑1 Data: Modest Weight Loss, Bigger Phase III Plan
Pfizer released Phase II data for PF‑08653944 (formerly Metsera’s candidate) showing placebo‑adjusted weight loss up to ~12.3% at 28 weeks and up to 10.5% in an alternative analysis — outcomes the...
Phylo Raises $13.5M Seed: Agentic AI for Lab Workflows
Phylo closed a $13.5 million seed round to launch Biomni Lab, an AI‑native integrated biology environment that embeds agentic AI into lab workflows for planning, execution and collaboration. The...
FDA Asks for Tavneos Withdrawal — Amgen Refuses: Regulation in the Hot Seat
The U.S. Food and Drug Administration has asked Amgen to withdraw Tavneos (avacopan) following scrutiny of old trial re‑adjudication practices and concerns over benefit‑risk signals; Amgen has...
BARDA/HHS Pledge $100M Prize for Broad‑Spectrum Antivirals
BARDA (via HHS) launched a $100 million prize competition to accelerate development of broad‑spectrum small‑molecule antivirals targeting Togaviridae and Flaviviridae families. The multi‑stage...
CIRM Commits $100M to Platform Gene‑Therapy Paths for Rare Diseases
California Institute for Regenerative Medicine approved a $100 million RAPID initiative to accelerate platform‑based in vivo genetic therapies for rare diseases. The program will fund scalable...
Wearable Aptamer Patch Clears Human Pilot: Continuous Drug Monitoring Arrives
A wearable electrochemical aptamer‑based patch demonstrated continuous, real‑time drug concentration measurements in healthy human participants in a pilot clinical trial, with findings reported in...
Hologic Wins Expanded FDA Clearance for Aptima HPV: Clinician‑Collected Primary Screening
The US Food and Drug Administration expanded Hologic’s Aptima HPV assay indication to include clinician‑collected primary HPV screening, adding flexibility for cervical cancer screening...
Congress Clears Medicare Path for FDA‑Approved MCED Tests — Coverage Comes in 2029
A federal spending bill approved by Congress includes a provision that will allow Medicare to cover FDA‑approved multi‑cancer early detection (MCED) tests starting in 2029, effectively decoupling...
Biotech IPO rebound: Eikon prices at top, Veradermics upsizes offering
Eikon Therapeutics completed a high-profile IPO, selling shares at the top of its range to raise $381 million and send a signal that well-funded, platform-driven biotechs can still access public...
Pfizer’s Metsera buy shows promise: monthly GLP‑1 posts competitive Phase 2 results
Pfizer disclosed Phase 2 data from the monthly GLP‑1 acquired through its $10 billion Metsera purchase, reporting clinically meaningful weight loss and confirming the drug's potential as a...
Lilly surge... GLP‑1 sales lift results and outlook
Eli Lilly reported results that beat street forecasts, driven by blockbuster performance of its GLP‑1 portfolio. Combined 2025 sales of Lilly’s obesity medicines—Zepbound and Mounjaro—surpassed...
Pediatric PRV reauthorized: lawmakers restore a rare‑disease incentive
Congress reauthorized the Pediatric Priority Review Voucher (PPRV) program through 2029 as part of a short‑term funding package, and industry groups including BIO hailed the move. BIO’s CEO John...