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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...
US-UK pharma accord: no tariffs in exchange for higher UK drug spending
The U.S. and U.K. reached an agreement that exempts British-origin pharmaceuticals from U.S. tariffs for three years in return for pricing concessions and higher UK spending on medicines. The deal...
Recipharm Advanced Bio begins PPQ for Infant Bacterial Therapeutics’ LBP
Recipharm Advanced Bio and Infant Bacterial Therapeutics (IBT) initiated a process performance qualification (PPQ) at Recipharm’s Cuxhaven microbial manufacturing site to validate commercial...
Singapore’s PRECISE partners with pharma majors to mine Asian genomic data
Precision Health Research, Singapore (PRECISE) announced a precompetitive collaboration with Alnylam, Bayer, Boehringer Ingelheim and Novo Nordisk to analyze data from the PRECISE‑SG100K...
Generate:Biomedicines advances to Phase 3 – TSLP antibody enters pivotal testing
Generate:Biomedicines announced the initiation of Phase 3 clinical studies for its lead TSLP (thymic stromal lymphopoietin) antibody, moving the AI-enabled discovery company’s lead program into...
Q32 sells complement asset to Akebia — $12M upfront for rare kidney program
Q32 Bio sold rights to its Phase II complement inhibitor ADX‑097 to Akebia Therapeutics for $12 million upfront, with up to $592 million in potential milestones, extending Q32’s cash runway and...
CRAFT CAR T and CAR T for CNS tumors: engineering safer, broader cell therapies
Researchers and companies presented advances in allogeneic CAR T approaches designed to reduce off‑target CRISPR risks (CRAFT CAR T) and to extend CAR T therapy into central nervous system (CNS)...
Regeneron bets $150M on Tessera: gene writing for AATD
Regeneron entered a global collaboration with Tessera Therapeutics to co-develop TSRA-196, a near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD). The deal includes...
Belite posts Phase 3 win — Stargardt drug meets primary endpoint
Belite Bio reported positive topline results from the Phase 3 DRAGON trial of tinlarebant in adolescents with Stargardt disease type 1, meeting the primary endpoint with a clinically meaningful...
Protego raises $130M — pushes AL amyloidosis program to pivotal
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT‑001, its oral candidate for AL (light‑chain) amyloidosis, toward a pivotal study. The financing was led by...
US vaccine path under rebuild — Prasad memo sparks policy firestorm
Federal vaccine policy is in flux after internal CBER memos and agency planning signalled a stricter evidentiary bar for vaccine approvals, prompting public debate and scrutiny. FDA leadership has...
Lundbeck exits Avadel chase — Alkermes cleared to acquire
Lundbeck withdrew from a bidding contest for Avadel Pharmaceuticals, locking in Alkermes’ path to acquire the sleep‑disorder drug developer under a roughly $2.37 billion bid that includes...
Q32 sells complement asset to Akebia: cash runway extended
Q32 Bio sold rights to its phase II complement inhibitor ADX‑097 to Akebia Therapeutics, generating upfront proceeds that materially extend Q32’s cash runway and let the small developer focus...
UK‑US pharma price pact: U.K. loosens rules to avoid U.S. tariffs
The U.K. agreed to relax certain drug‑pricing rules and increase spending on medicines in exchange for a U.S. decision not to impose tariffs on British‑origin pharmaceuticals, ingredients and...
Janux data shuffle: JANX007 shows mixed early‑stage prostate results
Janux Therapeutics released a new data cut from an ongoing Phase 1 study of JANX007, a T‑cell engager for metastatic castration‑resistant prostate cancer, showing response rates around 30% in the...