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Moderna/Merck personalized mRNA combo shows benefit — mRNA manufacturing advances
Interim Phase II data from Moderna and Merck’s personalized mRNA neoantigen vaccine combined with pembrolizumab showed a 49% reduction in melanoma recurrence and deaths in resectable high‑risk...
Single‑molecule proteomics maps alpha‑synuclein — Nautilus, Weill Cornell team up
Nautilus and Hilal Lashuel’s lab at Weill Cornell Medicine‑Qatar launched a collaboration backed by $1.6 million from the Michael J. Fox Foundation to apply Nautilus’s single‑molecule proteomics...
DeepMind’s AlphaGenome draws scrutiny — users ask for benchmark comparisons
Google DeepMind published AlphaGenome, an AI model that predicts functional effects of noncoding DNA across stretches up to one million base pairs, and released results in Nature. The model aims...
Insilico launches Science MMAI Gym; inks $120M cardiometabolic pact
Insilico Medicine announced Science MMAI Gym, a domain‑specific training infrastructure to fine‑tune large language models for drug discovery tasks such as DMPK and toxicity prediction. The...
Sequencing vendors shift support and distribution — Oxford extends P2 Solo life
Oxford Nanopore reversed an earlier deprecation plan and will extend hardware and software support for its PromethIon 2 Solo (P2 Solo) sequencer through 2030 after customer backlash. The company...
Cell‑therapy manufacturing and automation scale up — Cellares raises $257M
Cellares closed a $257 million Series D to scale its automated cell‑therapy manufacturing platform and prepare for a 2027 IPO, accelerating its commercial cell‑therapy production services. The...
CMS picks 15 drugs for round three: Biologics and Part B join negotiations
The Centers for Medicare & Medicaid Services released the 15 drugs slated for the third round of Inflation Reduction Act drug-price negotiations, expanding the program to include Part B...
FDA suspends Regenxbio trials after brain tumor discovery – Approval clock paused
The U.S. Food and Drug Administration placed clinical holds on two Regenxbio gene-therapy trials after a pediatric participant developed a brain tumor, prompting pause orders weeks ahead of a...
FDA lifts hold on one Intellia Phase 3 – CRISPR program advances cautiously
The FDA has lifted a clinical hold on one of Intellia’s two Phase 3 trials of its CRISPR/Cas9 therapy for transthyretin amyloidosis, allowing the Magnitude‑2 study in patients with polyneuropathy...
Lilly inks $1.12B recombinase pact – gene editing targets hearing loss
Eli Lilly struck a strategic collaboration and licensing deal with Seamless Therapeutics to apply Seamless’s programmable recombinase platform to genetic hearing loss, a pact worth up to $1.12...
DeepMind’s AlphaGenome draws scrutiny: users push validation and benchmarks
Google DeepMind published AlphaGenome, an AI model that predicts functional effects of noncoding DNA across up to one million base-pair sequences, and released the tool alongside a Nature paper....
Stealth AI biotech Hologen seeks $150M to build ‘large medicine models’
Hologen, a startup cofounded by former Google CEO Eric Schmidt, is raising a $150 million Series A to develop what it calls “large medicine models”—AI systems intended to model human biological...
AbbVie agrees $100B U.S. investment deal with administration to expand access
AbbVie reached a voluntary, decade‑long agreement with the U.S. administration to invest $100 billion in U.S.-based research, development and manufacturing while expanding direct‑to‑patient...
Personalized mRNA plus pembrolizumab halves melanoma relapse risk at five years
Five‑year interim data from a Phase II trial combining personalized mRNA neoantigen therapy (intismeran autogene/mRNA‑4157) with pembrolizumab show a 49% reduction in melanoma recurrence and...
HHS issues guidance to shield manufacturers for TrumpRx direct‑to‑consumer sales
The U.S. Department of Health and Human Services released guidance clarifying how manufacturers can sell drugs directly to consumers through the proposed TrumpRx platform while complying with the...
Cellares raises $257M as cell‑therapy manufacturing scales toward IPO
Cellares closed a $257 million Series D to expand its automated cell‑therapy manufacturing services and move toward commercial operations in advance of a planned 2027 IPO. The company plans to...
FDA halts Regenxbio trials amid pediatric brain‑tumor finding
The U.S. Food and Drug Administration placed clinical holds on two Regenxbio gene‑therapy studies after a pediatric trial participant was diagnosed with a brain tumor. Regenxbio had been testing...
Lilly bets up to $1.12B on recombinase gene editing for hearing
Eli Lilly struck a strategic global research and license pact with Seamless Therapeutics to program site‑specific recombinases aimed at correcting mutations that cause genetic hearing loss....
FDA partially lifts hold on Intellia’s CRISPR program — one study still suspended
Regulators have permitted Intellia Therapeutics to resume one of two Phase 3 trials of its CRISPR/Cas9 therapy (nexiguran ziclumeran, nex‑z) for transthyretin amyloidosis affecting peripheral...
Roche advances dual‑agonist obesity shot after robust mid‑stage readout
Roche reported phase‑2 results for CT‑388, a dual GLP‑1/GIP receptor agonist, showing a placebo‑adjusted weight loss of about 22.5% at 48 weeks in patients with obesity. The company announced...