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All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅

THE GOOD
Approvals & Labels

Egetis Therapeutics wins FDA approval for Emcitate (tiratricol), first US treatment for monocarboxylate transporter 8 deficiency
Small molecule, neurological, thyroid hormone disorder, MCT8 deficiency, Allan-Herndon-Dudley syndrome, rare pediatric disease - Read more

THE GOOD
Business Development & Partnerships

GSK exercises option on Wave Life Sciences' hepatic siRNA program, $12M upfront, $375M milestones
Licensing deal, RNA therapeutics, hepatology, milestone payments, royalties - Read more

CAS, Novartis Biomedical Research collaborate to advance AI-ready reaction informatics and drug discovery workflows
Research collaboration, AI/ML, drug discovery, data analytics, small molecule - Read more

AbbVie partners with Valkai to deploy AI capabilities across targeted clinical development areas
Research collaboration, AI/ML, clinical development, R&D, data analytics - Read more

Chugai Pharmaceutical, InxMed enter worldwide license agreement for RAF-MEK molecular glue SPYK04 in solid tumors
Licensing deal, oncology, small molecule, royalties - Read more

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Speakers confirmed include:

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✅ More Good News ✅

THE GOOD
Clinical Trials

Highlight Therapeutics' BO-112 meets primary endpoint in Ph2 trial for high-risk head and neck basal cell carcinoma
Immunotherapy, cancer, intralesional therapy, basal cell carcinoma, skin cancer - Read more

Eli Lilly shares Ph3 data on (retatrutide), GIP/GLP-1/glucagon triple agonist showing 25% body weight loss in obesity with type 2 diabetes
Small molecule, metabolic, GLP-1/GIP/glucagon receptor agonist, obesity, type 2 diabetes, cardiovascular risk - Read more

Amgen's (daxdilimab) achieves 6-point disease severity drop in Ph2 discoid lupus trial targeting ILT7
Antibody, autoimmune, monoclonal antibody, discoid lupus, ILT7 target, plasmacytoid dendritic cells - Read more

Roche, Zealand initiate Ph3 program for (petrelintide) in obesity after Ph2 amylin analog shows 9.8% peak weight loss
Protein therapy, metabolic, amylin analog, obesity, type 2 diabetes, cardiovascular disease - Read more

Connect Biopharma's (rademikibart) cuts chronic obstructive pulmonary disease exacerbations by 85% in Ph2 trial
Antibody, respiratory disease, monoclonal antibody, COPD, IL-4/IL-13 inhibitor, Dupixent competitor - Read more

Merck & Co.'s (tulisokibart) anti-TL1A antibody succeeds in Ph2 trial for moderate to severe hidradenitis suppurativa
Antibody, autoimmune, monoclonal antibody, hidradenitis suppurativa, anti-TL1A, TL1A target - Read more

Vanda Pharmaceuticals' Hetlioz (tasimelteon) achieves Ph3 win in delayed sleep-wake phase disorder, targeting melatonin MT1/MT2 receptors
Small molecule, neurological, melatonin receptor agonist, delayed sleep-wake phase disorder, circadian rhythm disorder - Read more

Eli Lilly's EloraTZP (eloralintide/tirzepatide) advances to Ph3 for obesity and type 2 diabetes after Ph2 success
Small molecule, metabolic, GIP/GLP-1 agonist, obesity, type 2 diabetes, combination therapy - Read more

Invivyd's VYD2311 demonstrates superior safety over mRNA-based COVID-19 vaccine in Ph3 LIBERTY study
Antibody, infectious disease, monoclonal antibody, COVID-19, pre-exposure prophylaxis - Read more

THE GOOD
Company Launches

Ortet launches as AI health lab with $500M from Thoreau, founded by ex-Genentech scientists
AI platform, personalized medicine, major transaction, strategic - Read more

THE GOOD
Fundraises

NorthStar Medical Technologies raises $185M growth capital facility for radiopharmaceutical isotope and CDMO expansion
Radiopharmaceutical, CDMO, isotope manufacturing, nuclear medicine - Read more

Nanomerics closes Series A, advancing ocular drug delivery platform and ophthalmology pipeline
Clinical-stage, ophthalmology, drug delivery, gene therapy, platform technology - Read more

THE GOOD
Politics & Policy

Ontario's QuickSTART program cuts clinical trial start-up to 45 days with $5M investment
Clinical trial infrastructure, life sciences, study start-up, trial efficiency - Read more

THE GOOD
Product Launches

Topos Bio launches Topos-2 and Topos-Bind AI models to target previously "undruggable" disease-causing proteins
AI drug discovery, neurological, oncology, small molecule - Read more

THE GOOD
Regulatory

NICE backs Merck KGaA's Ogsiveo (nirogacestat) as first systemic therapy for desmoid tumours following Ph3 success
Small molecule, cancer, gamma secretase inhibitor, desmoid tumour, nirogacestat, rare disease - Read more

Pierre Fabre, Atara Biotherapeutics resubmit Ebvallo (tabelecleucel) BLA to FDA for Epstein-Barr virus-positive posttransplant lymphoproliferative disease following Ph3 trial
Cell therapy, cancer, allogeneic T cell therapy, posttransplant lymphoproliferative disease, Epstein-Barr virus, tabelecleucel - Read more

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❌ The Bad News ❌

THE BAD
Lawsuits

Beam Therapeutics sues YolTech Therapeutics and Serapha Bio over alleged base editing trade secret theft
Base editing, rare disease, intellectual property, competitive - Read more

THE BAD
Layoffs

Enanta Pharmaceuticals lays off 37 employees amid key antiviral and immunology pipeline readouts
Small molecule, infectious disease, cost reduction, operational - Read more

THE BAD
Regulatory

AstraZeneca legal challenge strips Hansoh Pharma's Aumseqa of EU marketing authorization
Small molecule, oncology, competitive, regulatory - Read more

You’re all caught up on the latest Pharma & Biotech News!

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