Sanofi

Teva and Sanofi announce Phase 2b RELIEVE UCCD study met primary endpoints in UC and CD with duvakitug, showing high-dose efficacy. Plans for Phase 3 development pending regulatory discussions.

Durvalumab improved progression-free survival (PFS) over placebo in patients with locally advanced, unresectable non–small cell lung cancer (NSCLC) after platinum-based chemoradiotherapy (CRT), with a 25% reduction in risk of disease progression or death. Subgroup analysis showed consistent PFS benefit regardless of CRT type, and a trend toward improved overall survival (OS) was observed. PACIFIC-5 supports consolidation immunotherapy after either concurrent or sequential CRT.

Sanofi and Teva's Phase IIb RELIEVE UCCD study of duvakitug, a human IgG1-λ2 monoclonal antibody targeting TL1A, met primary endpoints in treating moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). In UC, 36.2% and 47.8% achieved remission at low and high doses, vs. 20.45% placebo. For CD, 26.1% and 47.8% showed endoscopic response. Duvakitug was well-tolerated with no safety concerns.

Recent biologics deals include Duality Biologics' exclusive option agreement with GSK for ADC candidate DB-1324, Keros Therapeutics' global license agreement with Takeda for elritercept, Merus' license agreement with Partner Therapeutics for NRG1+ cancer antibody Zeno, and Sanofi's opening of a modular vaccine and biopharmaceutical facility in Singapore.

The PharmaCongress 2025, on 8/9 April in Wiesbaden, focuses on digitalisation, AI, IoT, and Industry 4.0 in pharmaceutical production. It features eight conference tracks, live demonstrations, and a keynote by Dr. Maite Durrenbach on AI at Sanofi, and Dr. Ranjita Sahoo on 3D printing and new technologies. The GMP PharmaTechnica Expo includes 120 exhibitors and the Professor Wallhäußer Innovation Award ceremony.

2024 saw over 25 pediatric FDA approvals, including givinostat for Duchenne muscular dystrophy, FluMist for influenza, clonidine hydrochloride for ADHD, dupilumab for eosinophilic esophagitis, epinephrine nasal spray for anaphylaxis, and roflumilast cream for atopic dermatitis.

Teva and Sanofi's experimental drug duvakitug showed 'best-in-class potential' in Phase 2 trials for inflammatory bowel disease, with significant symptom improvement in ulcerative colitis and Crohn’s disease patients. The drug targets TL1A protein, a focus for several pharma companies. Teva and Sanofi plan to advance to Phase 3 pending regulatory discussions, with Sanofi set to pay Teva $600 million upon initiation.

Teva and Sanofi stocks rise after promising trial results for their experimental inflammatory bowel disease drug. Teva shares gain over 25% on Tuesday, doubling year-to-date.

Merck's clesrovimab, awaiting FDA approval by June 2025, aims to protect newborns from RSV, competing with Sanofi and AstraZeneca's Beyfortus. RSV vaccines for young children are on hold due to safety concerns. Merck's clesrovimab could be available for ordering by July if approved.

Indapta Therapeutics closed a $22.5M financing round to accelerate its allogeneic NK cell therapy development for cancer and autoimmune diseases. The funding supports ongoing trials of IDP-023 in NHL and MM, with initial MS trial data expected in Q1 2025. Indapta's platform aims to address unmet needs in blood and solid-tumor cancers and autoimmune diseases.