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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...
En Carta wins FDA breakthrough device tag for microneedle Lyme test
Paris‑based En Carta Diagnostics received Breakthrough Device designation from the FDA for EC Pocket Lyme, a point‑of‑care molecular test that detects Borrelia directly from skin interstitial...
Sensorion raises €60M as Sanofi takes strategic stake to back hearing programs
Sensorion SA closed a €60 million financing round, including a €20 million strategic investment from Sanofi, to advance a clinical program for SENS‑601 and other hearing‑loss candidates. The...
Cellares secures $257M to scale global cell‑therapy manufacturing and eye IPO
Cellares raised $257 million in a Series D round to expand commercial cell‑therapy manufacturing capabilities and position the company for a planned 2027 IPO. The funding will support deployment...
Eclipsebio acquires Terrain Bio to fuse ML RNA design with sequencing analytics
RNA genomics firm Eclipsebio acquired Terrain Bio to accelerate an end‑to‑end RNA design, manufacturing, and validation platform. Terrain’s machine‑learning RNA analytics will be integrated with...
Danaher posts stronger‑than‑expected Q4 as bioprocessing sales drive growth
Danaher reported Q4 revenue of $6.84 billion, up about 5% year‑over‑year and topping analyst estimates, powered by continued strength in bioprocessing and life‑sciences consumables. The...
Biopharma Sentiment Index climbs — optimism returns but uncertainty remains
The Biopharma Sentiment Index rose to 90 in Q1 2026, up from 78 the prior quarter, signaling a broad improvement in industry mood driven by dealmaking and capital access. The index, produced by...
FDA lifts hold on one Intellia trial: Magnitude-2 cleared, cardiomyopathy study remains paused
The U.S. Food and Drug Administration has lifted a clinical hold on Intellia Therapeutics’ Magnitude-2 Phase 3 trial testing CRISPR therapy nexiguran ziclumeran (nex‑z) for transthyretin...
FDA halts Regenxbio gene therapy trials after child develops brain tumor
The FDA paused two Regenxbio gene therapy trials after the company reported a child participant developed a brain tumor, the company and STAT reported. The affected programs aim to replace broken...
Lilly inks up-to-$1.12B Seamless pact: recombinase editing for hearing loss
Eli Lilly struck a global research and licensing agreement with TU Dresden spinout Seamless Therapeutics to deploy programmable recombinases for genetic hearing‑loss therapies, with deal economics...
Cellares raises $257M: cell therapy contract manufacturer scales toward IPO
Cellares closed a $257 million Series D round to accelerate global expansion of its automated cell therapy manufacturing platform and to prepare for a planned 2027 IPO. The funding is intended to...
Roche’s mid‑stage obesity shot posts double‑digit loss... Phase 3 next
Roche reported Phase 2 results for its dual GLP‑1/GIP agonist CT‑388 showing roughly 22.5% placebo‑adjusted weight loss at 48 weeks, and announced plans to advance the candidate into Phase 3 by...
Parse and Graph join to build massive immune perturbation atlas
Parse Biosciences and Graph Therapeutics formed a strategic partnership to generate a large, functional immune perturbation atlas by combining Graph’s patient‑derived perturbation assays with...