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CMS opens round three of Medicare drug price talks — 15 drugs named
The Centers for Medicare & Medicaid Services published the third‑round slate of 15 high‑spend medicines selected for Inflation Reduction Act‑enabled price negotiations, marking the first inclusion...
FDA lifts hold on one Intellia CRISPR trial — cardiac study still paused
The FDA has lifted a clinical hold on Intellia Therapeutics’ Phase 3 trial of its CRISPR/Cas9 investigational therapy for transthyretin amyloidosis with polyneuropathy (ATTR‑PN), allowing that...
DeepMind releases AlphaGenome — AI maps noncoding DNA function
Google DeepMind unveiled AlphaGenome, an AI model that analyzes up to one million base‑pair stretches of noncoding DNA and predicts how mutations affect gene expression. The work, described in...
Moderna + Merck interim data: mRNA neo‑antigen plus pembrolizumab halves melanoma recurrence
Moderna and Merck released five‑year interim data from a Phase II trial combining individualized mRNA neoantigen immunotherapy (mRNA‑4157; intismeran autogene) with pembrolizumab in resected...
Oxford Nanopore reverses course — P2 Solo support extended to 2030
Following widespread customer backlash, Oxford Nanopore Technologies announced it will extend hardware and software support for its PromethION 2 Solo (P2 Solo) sequencer through the end of 2030....
FDA greenlights Life Biosciences’ reprogramming trial — first human test of age‑reversal approach
The FDA has approved Life Biosciences to begin a first‑in‑human study testing an in‑eye gene‑therapy reprogramming approach intended to reverse cellular aging markers. The trial will enroll a...
FDA halts Regenxbio trials: brain tumor prompts clinical holds
The FDA placed clinical holds on two Regenxbio gene therapy programs after a child in a trial developed a brain tumor, halting work on a treatment that was weeks from a regulatory decision....
Lilly inks up-to-$1.12B recombinase pact – Seamless deal validates platform
Eli Lilly struck an exclusive collaboration with Seamless Therapeutics to apply programmable recombinase gene editing to hearing-loss targets in a deal worth up to $1.12 billion. Seamless will...
CMS names Round 3 drugs: 15 medicines enter Medicare price talks
The Centers for Medicare & Medicaid Services released the third-round slate of 15 drugs selected for Inflation Reduction Act–enabled price negotiations, the first group to include Medicare Part B...
Roche’s GLP-1/GIP posts competitive Phase 2 weight loss…Phase 3 next
Roche reported mid‑stage data for CT-388, a dual GLP‑1/GIP agonist, showing competitive weight‑loss efficacy in a Phase 2 study and confirmed plans to move the candidate into Phase 3 testing. The...
Intellia resumes one CRISPR Phase 3 — another remains paused
The FDA lifted a clinical hold on Intellia’s Magnitude‑2 Phase 3 trial of its in vivo CRISPR therapy nexiguran ziclumeran (nex‑z) for transthyretin amyloidosis with polyneuropathy (ATTR‑PN) while...
DeepMind’s AlphaGenome: AI decodes noncoding DNA at scale
Google DeepMind unveiled AlphaGenome, a deep learning model that predicts functional effects of mutations across long stretches of noncoding DNA, and published the work in Nature. AlphaGenome...
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...