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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...
IND clearance and Phase‑3 launches: ideaya, Generate push oncology and immunology
Ideaya Biosciences received FDA IND clearance to initiate a Phase I study of IDE‑034, a bispecific B7H3/PTK7 TOP1 antibody‑drug conjugate targeting solid tumors. The clearance opens human testing...
CDMO and CRO deals accelerate commercial readiness in biologics and trials
Recipharm Advanced Bio began process performance qualification runs for Infant Bacterial Therapeutics’ lead live biotherapeutic product, IBP‑9414, at its Cuxhaven microbial manufacturing...
Tessera, Regeneron ink $150M gene-writing pact – TSRA-196 development
Tessera Therapeutics and Regeneron Pharmaceuticals signed a multi-million dollar collaboration to develop TSRA-196, Tessera’s near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin...
Protego closes $130M Series B – advances oral AL amyloidosis program to pivotal
Protego Biopharma closed an oversubscribed $130 million Series B to finance PROT-001, its oral candidate for AL (light-chain) amyloidosis, and to support a planned pivotal study. The round was led...
Belite’s tinlarebant clears Phase 3 – Stargardt approval path opens
Belite Bio reported positive top-line results from the global Phase 3 DRAGON trial: oral tinlarebant met its primary endpoint in adolescents with Stargardt disease type 1, showing a statistically...
Prasad memo roils vaccine sector – market and policy fallout
An internal FDA memo from CBER director Vinay Prasad proposing sweeping changes to vaccine approval and authoring processes became public, prompting immediate sector reaction and stock moves. The...