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Moderna+Keytruda combo cuts melanoma recurrence in Phase 2 interim readout
Moderna and Merck published five‑year interim results from the Phase 2 KEYNOTE trial combining personalized mRNA neoantigen therapy intismeran autogene (mRNA‑4157) with pembrolizumab, reporting a...
Ex‑Google CEO’s Hologen raises ambitions; Insilico launches specialized ‘gym’ for drug LLMs
Hologen, an AI‑driven biotech co‑founded by former Google CEO Eric Schmidt, is reportedly seeking $150 million to build 'large medicine models' aimed at improving trial signal detection and...
mRNA manufacturing advances: acid denaturation of dsRNA and real‑time cell‑health sensors
Process teams published methods that could sharpen mRNA vaccine and therapeutic manufacturing: Sartorius and collaborators demonstrated rapid pH‑driven denaturation of dsRNA impurities at pH ≤3.5...
Cell therapy capacity race: Cellares raises $257M as bioprocess demand surges
Cellares closed a $257 million Series D to expand its commercial cell therapy manufacturing services and accelerate plans for a 2027 IPO, signaling rising demand for outsourced large‑scale cell...
FDA halts Regenxbio trials after tumor found – agency suspends studies
The U.S. Food and Drug Administration placed clinical holds on Regenxbio’s gene‑therapy programs after investigators detected a brain neoplasm in a pediatric trial participant. Regenxbio said the...
FDA lifts hold on Intellia CRISPR trial – one study resumes
The FDA has lifted a clinical hold on one of Intellia Therapeutics’ two Phase III trials of its CRISPR in vivo candidate nexiguran ziclumeran (nex‑z), allowing the Magnitude‑2 study in...
Lilly inks up‑to‑$1.12B recombinase pact with Seamless – hearing loss push
Eli Lilly agreed to a global research and licensing deal with Seamless Therapeutics potentially worth $1.12 billion to apply Seamless’s programmable recombinase gene‑editing platform to genetic...
CMS names 15 drugs for third‑round IRA negotiations — Medicare pricing moves
The Centers for Medicare & Medicaid Services unveiled 15 high‑spend medicines selected for the third round of Inflation Reduction Act negotiations, marking the first time Medicare Part B drugs...
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...