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Amgen Real-World Study Links Evolocumab to Lower Heart Attack Risk Than Ezetimibe

FDA Approves Rybrevant Faspro for Advanced Head and Neck Cancer

Alethio Raises $90 Million to Advance First-in-Class G6B Antibody for Essential Thrombocythemia

T-Therapeutics Raises $133 Million to Take TCR Bispecifics Into the Clinic

The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific

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FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.

Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.

Akeso won NMPA priority review for ivonescimab plus chemotherapy in first-line biliary tract cancer after a phase 3 win over durvalumab plus chemo.

VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.

UCB will use Cradle’s AI-driven protein design platform in selected discovery projects, from hit generation through preclinical readiness, expanding its digital antibody engineering program.

Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.

Matt Trupo, Richard Jaenisch, and Brian Drapeau explore how AI advances biological insights, drug-target discovery, and supply chains.

As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.

Aldevron and IDT added PE Ultra prime editor mRNA and 6 ABE8e base editor mRNAs to help researchers edit DNA without double-strand breaks.

The half-life-extended antibody failed its primary endpoints in two Phase 2 SKYWAY sub-studies, so Spyre is dropping it in rheumatic diseases and moving it into a combination trial in hidradenitis suppurativa.

Biora will test oral adalimumab via its BioJet capsule vs injection in healthy volunteers, with dosing from December 2026 and data in early 2027.

Boehringer Ingelheim will pay Sino Biopharmaceutical $358 million upfront and near-term for options on six biologic oncology programs, deepening a partnership that began in 2024.

A former CIA officer, Pacific Research Institute economists, and industry groups say Treasury's proposed COINS Act biotechnology restrictions are too broad, while the National Security Commission on Emerging Biotechnology backs the move. Comments are due December 7, 2026.

Shilpa CDMO's $50 million plan adds 10 kL of SPPS reactor capacity in Raichur, India, with its first commercial peptide line opening in December 2026.

Today’s BioPharm Brief covers FDA’s final potency assurance guidance for cell and gene therapies, Lonza’s deal to acquire Merck KGaA’s US CDMO business, and Phase 2a data for Tiziana’s intranasal anti-CD3 antibody foralumab in progressive multiple sclerosis.




















