Get the Daily Brief
Latest Biotech News
Moderna/Merck mRNA‑antibody combo halves melanoma recurrence in interim read
Moderna and Merck released five‑year interim results from a personalized mRNA neoantigen therapy (intismeran autogene, mRNA‑4157) combined with pembrolizumab that showed a 49% reduction in...
Cellares grabs $257M to scale cell‑therapy manufacturing and prep IPO
Cellares raised $257 million in a Series D extension to accelerate global expansion of its automated cell‑therapy manufacturing services and prepare for a planned 2027 public listing. The company...
AbbVie pledges $100B in U.S. investment under administration deal
AbbVie reached a voluntary agreement with the U.S. administration committing up to $100 billion in U.S. research, development and manufacturing investments over the next decade tied to expanded...
Roche drops $100M fibrosis asset after futility read—pipeline pared
Roche removed vixarelimab, an anti‑OSMRβ antibody acquired via its 2022 transaction with Kiniksa, from its Phase‑2 fibrosis pipeline after an interim futility analysis concluded the study was...
FDA halts Regenxbio trials — brain tumor found in pediatric patient
The U.S. Food and Drug Administration placed clinical holds on two Regenxbio gene‑therapy programs after investigators found a brain neoplasm in a young trial participant. The holds affect an...
AbbVie pledges $100bn to US R&D — deal with Trump administration
AbbVie struck a voluntary agreement with the U.S. administration committing up to $100 billion in U.S. research, development and manufacturing investment over the next decade in exchange for...
Lilly inks up-to‑$1.12B recombinant gene-editing pact with Seamless for hearing loss
Eli Lilly entered a strategic collaboration and licensing agreement with Seamless Therapeutics to apply Seamless’s programmable recombinase gene‑editing platform to develop hearing‑restorative...
Roche’s CT‑388 posts competitive Phase 2 weight‑loss — heads to Phase 3
Roche reported Phase 2 data for CT‑388, a dual GLP‑1/GIP agonist, showing placebo‑adjusted weight loss of roughly 22.5 percentage points at 48 weeks in an obesity trial. The Swiss pharma said the...
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...