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Singapore’s PRECISE teams with pharma to mine 100K genomes
Singapore’s PRECISE program announced precompetitive partnerships with Alnylam, Bayer, Boehringer Ingelheim and Novo Nordisk to analyze data from its PRECISE‑SG100K cohort. The collaboration will...
ICON commits $300M to AI and digital innovation over three years
ICON, the Ireland‑based CRO, announced a planned $300 million investment in AI and digital technologies over the next three years to modernize trial operations, data capture and analytics. CEO...
Regeneron bets $150M on Tessera’s gene writer: TSRA‑196 pact
Regeneron signed a multi‑year collaboration and upfront payment worth roughly $150 million to co-develop Tessera Therapeutics’ TSRA‑196, a near-clinic gene‑writing candidate for alpha‑1...
Belite’s tinlarebant clears Phase III — FDA filing next
Belite Bio posted positive top‑line results from its 104‑patient Phase III DRAGON trial: oral tinlarebant achieved the primary endpoint by slowing the growth rate of retinal lesions in Stargardt...
Protego nets $130M — pivots PROT‑001 toward pivotal study
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT‑001, its first‑in‑class oral therapy for AL (light chain) amyloidosis, into a pivotal study. The financing draws...
CBER memo roils markets: FDA vaccine rules under overhaul
An internal memo from CBER director Vinay Prasad outlining a proposed overhaul of U.S. vaccine approval policy became public, triggering market and industry reaction. The document recommends...
Cytokinetics’ first approval nears — prepares David vs. Goliath fight
Cytokinetics is approaching its first regulatory approval after nearly 30 years in business as it positions aficamten, an oral therapy for obstructive cardiomyopathy, for market entry. Wall Street...
Imvax presses FDA after mixed glioblastoma Phase 2b readout
Imvax reported Phase 2b data in glioblastoma showing no hit on the trial’s primary endpoint but a clinically meaningful overall survival benefit — roughly six months longer than standard of care —...
UK raises drug prices to avert US pharma tariffs
Washington and London reached an agreement in principle that trades a temporary U.S. tariff reprieve on U.K. pharmaceuticals for U.K. concessions on drug pricing and increased medicines spending....
Profluent pulls in $106M — scales AI protein design platform
Profluent closed a $106 million Series B led by Altimeter Capital and Bezos Expeditions to accelerate its AI‑driven protein design platform into therapeutic, agricultural and biomanufacturing...
Recursion’s leadership pivot — heavy AI users reshape biotech
Recursion appointed Najat Khan, PhD, as CEO effective January 1, signaling a strategic shift from platform building to delivering clinical proof points. The leadership change follows the company’s...
EIB, Angelini commit €150M to seed Europe’s health startups
The European Investment Bank and Angelini Ventures announced a €150 million investment vehicle targeting seven to ten European health startups across biotech, medtech and digital health. The...
Regeneron bankrolls Tessera: $150M gene‑writing pact
Regeneron and Tessera struck a development and commercialization agreement that funnels roughly $150 million toward Tessera’s in‑vivo gene‑writing candidate TSRA‑196 for alpha‑1 antitrypsin...
Protego nets $130M: readies AL amyloidosis pivotal study
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT‑001, an oral candidate for AL (light‑chain) amyloidosis, toward a pivotal trial next year. The financing was led by...
Belite's pill slows Stargardt lesions – FDA filing eyed
Belite Bio reported positive topline Phase III DRAGON data: oral tinlarebant met the primary endpoint by reducing the growth rate of retinal lesions in Stargardt disease type 1. The company said...
Profluent raises $106M: AI protein design scales to therapeutics
Profluent closed a $106 million Series B co‑led by Altimeter Capital and Bezos Expeditions to accelerate its AI‑driven protein design platform into therapeutics, agriculture and biomanufacturing....
Researchers scale lung organoids: stirred bioreactor enables bulk manufacture
A team at the University of Duisburg‑Essen reported an automated stirred‑tank bioreactor method to produce induced pluripotent stem cell‑derived lung organoids at scale. The protocol yields large...
Singapore's PRECISE taps big pharma: Asian genomics partnership formed
Singapore’s PRECISE program announced a precompetitive collaboration with Alnylam, Bayer, Boehringer Ingelheim and Novo Nordisk to analyze data from the PRECISE‑SG100K population study. The...
FDA memo sparks sell‑off – vaccine developers brace for tougher rules
A leaked internal memo from CBER director Vinay Prasad proposing major changes to vaccine approval and use prompted market and policy ripples. The document questions pandemic‑era shortcuts and...
Stem‑cell transplant cases nudge HIV remission narrative: durable control reported
New reports detail sustained HIV remission following stem cell transplantation approaches, including cases without classic CCR5Δ32 homozygosity. Researchers described durable viral control after...