
Ultragenyx wins first gene therapy FDA approval for Genglycos (DTX401) targeting glycogen storage disease type Ia via Ph3 | Gif: workingtitlefilms on Giphy
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
Ultragenyx wins first gene therapy FDA approval for Genglycos (DTX401) targeting glycogen storage disease type Ia via Ph3
Gene therapy, metabolic, AAV vector, glycogen storage disease, rare disease - Read more
Regeneron wins FDA approval for Pasatru (garetosmab) targeting Activin A in fibrodysplasia ossificans progressiva based on Ph3 data
Antibody, rare bone disease, monoclonal antibody, fibrodysplasia ossificans progressiva, Activin A, heterotopic ossification - Read more
Eli Lilly's once-weekly insulin Onswik receives NICE recommendation for NHS coverage in UK
Injectable insulin, type 2 diabetes, regulatory, coverage - Read more
Vitestro's Aletta becomes first FDA-approved robotic blood draw device, addressing phlebotomist shortage
Robotic medical device, phlebotomy, regulatory, operational, investment - Read more
NICE backs Axunio UK's Axhidrox (glycopyrronium bromide) for severe primary axillary hyperhidrosis following Ph3 success
Small molecule, dermatological, anticholinergic, hyperhidrosis, glycopyrronium bromide - Read more
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✅ More Good News ✅
THE GOOD
Business Development & Partnerships
Eli Lilly, Amplitude Therapeutics collaborate on taRNA vaccine platform targeting infectious diseases
Research collaboration, infectious disease, vaccine, RNA platform, drug discovery - Read more
Chai Discovery, Bristol Myers Squibb collaborate on AI-powered therapeutic antibody discovery
Research collaboration, AI/ML, antibody, drug discovery - Read more
AlzeCure Pharma, Eli Lilly complete Alzstatin licensing deal, $10M upfront, $1B+ milestones
Licensing deal, neurological, small molecule, milestone payments, royalties - Read more
Akiram Therapeutics, ITM sign Lu-177 supply agreement to advance AKIR001 for solid tumors
Manufacturing agreement, oncology, radiopharmaceuticals, antibody, clinical trials - Read more
Onco-Innovations Limited, Ifowonco Informatics sign LOI for exclusive worldwide licence to LAG-3 small-molecule inhibitor program
Licensing deal, oncology, small molecule, immune checkpoint, co-development - Read more
Simcere Pharmaceutical Group, Ruiyang Biopharmaceutical partner to commercialize RSV monoclonal antibody kuleveibaimab in Greater China
Commercialization, infectious disease, antibody, licensing deal - Read more
THE GOOD
Company Launches
Network Bio launches with $50M and NVIDIA partnership to build cross-disease AI medical intelligence platform
AI/machine learning, multiple disease areas, strategic, major transaction - Read more
THE GOOD
Fundraises
Kynexis raises €97M ($113M) Series A, advancing cognitive impairment schizophrenia drug to registrational development
Neurological, small molecule, cognitive disorders, clinical-stage, schizophrenia - Read more
Pixelgen Technologies closes $15.5M oversubscribed Series B to accelerate global commercialization
Biomarker discovery, platform technology, proteomics, cancer, autoimmune - Read more
Amylyx Pharmaceuticals plans $500M share sale to fund avexitide PBH treatment launch preparations
Rare disease, small molecule, metabolic disease, clinical-stage - Read more
KaliVir Immunotherapeutics closes $14M Series A extension, advancing oncolytic immunotherapy clinical trial
Oncology, oncolytic immunotherapy, clinical-stage, solid tumors, viral platform - Read more
Greenstone Biosciences receives undisclosed Breakthrough T1D grant for islet cell platform development
AI-driven, iPSC platform, type 1 diabetes, drug discovery, organoids - Read more
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❌ The Bad News ❌
THE BAD
Business Development & Partnerships
Amgen terminates TScan Therapeutics Crohn's disease collaboration, walking away from $530M deal
Licensing deal, autoimmune, drug discovery, milestone payments, royalties - Read more
THE BAD
Regulatory
B. Braun Medical recalls IV solution in US and Canada over particulate contamination concerns
IV solution, hospital operations, product safety, operational - Read more
France recalls Amgen's Tavneos after 20 deaths reported in Japan, EU revokes marketing authorisation
Small molecule, rare disease, safety, regulatory - Read more
You’re all caught up on the latest Pharma & Biotech News!
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