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Terray hits BMS milestone: AI‑chip platform delivers discovery breakthrough
Terray Therapeutics announced it achieved the first discovery milestone under its multi‑target collaboration with Bristol Myers Squibb, validating its Experimentation Meets Machine Intelligence...
Ginkgo wins $47M DOE‑linked contract to automate phenotyping at PNNL
Ginkgo Bioworks secured a four‑year, $47 million contract to design and build an automated phenotyping platform for the Pacific Northwest National Laboratory and its Environmental Molecular...
ACIP in disarray: hepatitis B birth-dose vote delayed then reversed
An advisory swirl over newborn hepatitis B vaccinations culminated this week in procedural chaos and a contentious policy shift. Early in the week the CDC’s Advisory Committee on Immunization...
Ex-FDA chiefs lambaste vaccine policy—agency taps Høeg to run CDER
Twelve former FDA commissioners publicly condemned proposed vaccine-policy changes and accused the agency’s biologics chief of threatening longstanding regulatory standards, publishing their...
Capricor’s DMD win ignites rally—company prices $150M follow-on
Capricor Therapeutics reported positive top-line Phase III data for its cell therapy deramiocel in Duchenne muscular dystrophy, prompting a dramatic market reaction and a strategic financing push....
FDA pauses Denali trial... company secures $275M royalty financing
Regulatory friction and financing maneuvers converged for Denali Therapeutics this week. The FDA placed a hold on Denali’s planned Phase 1 study for a Pompe-disease candidate, requesting protocol...
UniQure’s Huntington filing clouded—FDA feedback forces reassessment
UniQure warned investors that the FDA’s recent feedback on its Huntington’s disease gene therapy will likely delay an anticipated approval filing and complicate its regulatory path. The company...
Natera buys Foresight for $275M to bolster MRD detection
Natera acquired Foresight Diagnostics for $275 million upfront plus up to $175 million in milestones to integrate high-sensitivity phased-variant ctDNA technology into its Signatera minimal...
Triana closes $120M Series B to advance molecular-glue degraders
Triana Biomedicines closed an oversubscribed $120 million Series B to advance its molecular-glue degrader platform and push lead candidate TRI-611 toward the clinic for ALK-driven non–small-cell...
Pfizer Ventures backs OTR’s $100M series A—China biotech broadens R&D hub
OTR Therapeutics, a Shanghai-based biotech, closed a $100 million Series A to build a diversified R&D and asset portfolio, with participation from Pfizer Ventures. The company said it will combine...
Illumina pivots to data: BioInsight to sell sequencing datasets and analytics
Illumina announced plans to expand beyond reagents and instruments by offering curated, high-value genomic datasets and analytics to pharmaceutical partners through a new BioInsight unit. The...
Invenirex raises seed cash for enzyme‑free 'nanite' nucleic-acid detection
Newcastle startup Invenirex closed a £2 million seed round to commercialize an enzyme‑free nucleic acid detection platform built around programmable DNA microstructures dubbed 'nanites.' The...
CDER turnover spikes — Pazdur retires, Høeg steps in
FDA leadership shifted again this week as Richard Pazdur filed retirement paperwork after a brief tenure and Tracy Beth Høeg, a Makary deputy and vaccine-safety investigator, was named acting...
Prasad defends probe: former FDA chiefs issue blistering rebuke
CBER director Vinay Prasad publicly defended his proposed vaccine-policy changes at a closed-door investor forum, blaming "misleading media narratives" for the escalation of criticism. His remarks...
ACIP in disarray: hepatitis B birth-dose vote delayed again
The CDC’s Advisory Committee on Immunization Practices (ACIP) adjourned without resolving whether the universal newborn hepatitis B birth dose recommendation should be changed, delaying a...
Duchenne milestone: Capricor’s cell therapy clears Phase III endpoints, stock rockets
Capricor Therapeutics reported top-line Phase III results for deramiocel in Duchenne muscular dystrophy that met both the primary upper-limb functional endpoint and a key cardiac secondary...
Semaglutide’s Alzheimer hopes dashed — CTAD data show no cognitive benefit
Novo Nordisk’s oral semaglutide failed to demonstrate a slowing of cognitive decline in the Evoke and Evoke+ Phase III programs, according to topline results presented at CTAD and company...
Triana pulls in $120M — molecular glue developer eyes clinic
Triana Biomedicines closed a $120 million Series B financing to advance its molecular glue degrader platform and push lead candidate TRI-611 into clinical development for ALK-driven non–small cell...
German court blocks Keytruda SC — Halozyme wins injunction
A German regional court granted Halozyme a preliminary injunction ordering Merck to halt distribution of subcutaneous Keytruda (pembrolizumab SC) in Germany, advancing a broader patent dispute...
In vivo editing of human HSPCs: envelope‑engineered VLPs enable direct therapy
Researchers published a Nature Biotechnology report describing envelope-engineered virus‑like particles (VLPs) capable of delivering gene‑editing cargo to human hematopoietic stem and progenitor...