
FDA approves Eli Lilly's Onswik (insulin efsitora alfa-gobe) for type 2 diabetes in Ph3-backed once-weekly insulin | Gif: showtimesports on Giphy
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
FDA approves Eli Lilly's Onswik (insulin efsitora alfa-gobe) for type 2 diabetes in Ph3-backed once-weekly insulin
Protein therapy, metabolic, insulin, type 2 diabetes, weekly injection - Read more
FDA approves Elevar Therapeutics' Lyrfigtu (lirafugratinib) for FGFR2-altered cholangiocarcinoma based on Ph1/Ph2 data
Small molecule, cancer, FGFR inhibitor, cholangiocarcinoma, FGFR2 fusion - Read more
THE GOOD
Business Development & Partnerships
Henlius Biotech, Amberstone Biosciences strike $440M T-cell engager deal using T-Mate platform
Licensing deal, oncology, T-cell engager, antibody, milestone payments, royalties - Read more
Eli Lilly, InnoCare Pharma partner on five unmet need targets, $100M upfront, $3.25B milestones
Co-development, oncology, autoimmune, drug discovery, milestone payments, royalties - Read more
Roche, Atavistik Bio partner on cardiometabolic small molecule drug discovery, $70M upfront, $1.9B milestones
Research collaboration, cardiometabolic, small molecule, drug discovery, milestone payments, royalties - Read more
Flen Health selects AGC Biologics as CDMO for recombinant enzyme wound treatment manufacturing and clinical trials
Manufacturing agreement, wound care, recombinant proteins, CDMO, microbial manufacturing - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
Kyverna Therapeutics reports 1-year Ph3 miv-cel (mivocabtagene autoleucel) data showing durable efficacy in stiff person syndrome with clean safety profile
Cell therapy, autoimmune, CAR-T, stiff person syndrome, myasthenia gravis, cytokine release syndrome - Read more
Merck & Co.'s (remigromig) meets primary endpoint in Ph2b/3 trial for diabetic macular edema, Wnt pathway agonist shows noninferiority
Protein therapy, ophthalmology, trispecific antibody, diabetic macular edema, Wnt signaling pathway, VEGF inhibitor - Read more
ImmuneOnco Biopharmaceuticals' (amulirafusp alfa) targeting CD47/CD20 shows 92.3% overall response rate in Ph1b/2a marginal zone lymphoma trial
Antibody, cancer, myeloid cell engager, non-Hodgkin lymphoma, CD47, combination therapy - Read more
THE GOOD
Fundraises
Basecamp Research raises $140M Series C to advance AI-designed drug pipeline
AI/ML platform, drug discovery, cell therapy, gene therapy, platform-enabled - Read more
BigHat Biosciences raises $75M Series C, advancing AI-designed biologic pipeline
AI/ML platform, antibody-drug conjugate, protein design, oncology, clinical-stage - Read more
Tempo Therapeutics receives $2.25M NIH SBIR grant to advance MAP Wound Matrix clinical study
Regenerative medicine, synthetic biomaterials, wound healing, clinical-stage - Read more
Big Picture Bio raises £1.5M (~$2M) Pre-Seed funding to expand operations and R&D efforts
Cancer, AI/ML platform, drug discovery, combination therapy, preclinical - Read more
United Immunity raises ¥2.2B (~$13.9M), advancing macrophage engineering programs for solid tumors and fibrosis
Myeloid targeting, nanoparticle, oncology, fibrosis, autoimmune, clinical-stage - Read more
THE GOOD
Product Launches
ArcaScience launches Flow AI software to automate drug benefit-risk assessments and regulatory submissions
AI software, drug safety, regulatory, operational - Read more
THE GOOD
Regulatory
Grail's Galleri multi-cancer blood test receives positive FDA advisory committee recommendation for adults aged 50 and over
Diagnostic test, cancer, liquid biopsy, multi-cancer early detection, screening - Read more
THE GOOD
Strategic Plans
Novo CEO open to NYSE listing to attract U.S. investors amid market share pressure
Stock listing, GLP-1, strategic, financial, competitive - Read more
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❌ The Bad News ❌
THE BAD
Clinical Trials
Acadia Pharmaceuticals' (remlifanserin) Ph2 misses primary endpoint in Alzheimer's disease psychosis, Ph3 continues
Small molecule, neurological, inverse agonist, Alzheimer's disease, psychosis, 5HT2A receptor - Read more
THE BAD
Layoffs
Adagio Medical launches strategic review, cuts over half its workforce amid Nasdaq delisting threat
Cryoablation device, cardiovascular, strategic, cost reduction - Read more
THE BAD
Regulatory
Otsuka ICU Medical recalls one sodium chloride lot over potassium chloride mislabeling, risking fatal outcomes
IV solutions, patient safety, operational, recall - Read more
You’re all caught up on the latest Pharma & Biotech News!
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