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THE GOOD
Approvals & Labels

Ireland's HSE approves UCB's Bimzelex (bimekizumab) for hidradenitis suppurativa and axial spondyloarthritis treatment
Antibody, autoimmune, monoclonal antibody, hidradenitis suppurativa, axial spondyloarthritis, IL-17 inhibitor - Read more

Zydus receives FDA approval for Verapamil Hydrochloride (verapamil) extended-release tablets targeting calcium channels for hypertension
Small molecule, cardiovascular, calcium channel blocker, hypertension, extended-release formulation - Read more

Dr. Reddy's wins European Commission approval for AVT03 (denosumab) biosimilar targeting RANK ligand for osteoporosis
Antibody, cancer, monoclonal antibody, osteoporosis, biosimilar, RANK ligand - Read more

IASO Bio's Fucaso (equecabtagene autoleucel) wins Hong Kong approval for relapsed or refractory multiple myeloma
Cell therapy, cancer, CAR-T, multiple myeloma, BCMA target - Read more

Celltrion receives Health Canada approval for Eydenzelt (aflibercept) biosimilar targeting vascular endothelial growth factor for ophthalmology indications
Protein therapy, ophthalmology, biosimilar, diabetic macular edema, aflibercept, VEGF inhibitor - Read more

Innovent Biologics' Pecondle (picankibart) wins China NMPA approval for moderate-to-severe plaque psoriasis targeting interleukin-23p19
Antibody, autoimmune, monoclonal antibody, plaque psoriasis, IL-23 target - Read more

THE GOOD
Business Development & Partnerships

eXmoor Pharma, Royal Free London collaborate on UK gene therapy manufacturing pathway development
Strategic collaboration, gene therapy, cell therapy, manufacturing, R&D - Read more

mAIbe, LenioBio collaborate on AI-driven monoclonal antibody discovery and validation platform
Research collaboration, antibody, AI/ML, drug discovery - Read more

Curapath, Cristal Therapeutics sign co-exclusive license for CliCr bioconjugation platform for targeted drug delivery
Licensing deal, drug delivery, bioconjugation technology, manufacturing agreement, nucleic acid therapeutics - Read more

Prestige Biopharma, Biosidus enter exclusive license agreement for Tuznue commercialization in Latin America
Licensing deal, oncology, antibody, commercialization - Read more

Sinovac, Brazil's health ministry sign $700M vaccine supply deal for chickenpox, rabies vaccines
Manufacturing agreement, vaccine, infectious disease, supply deal - Read more

SK Biopharmaceuticals in-licenses radiopharmaceutical therapy candidate WT-7695 from Wisconsin Alumni Research Foundation, targeting carbonic anhydrase IX
Licensing deal, oncology, radiopharmaceutical, small molecule, R&D - Read more

Teijin Pharma receives $5M milestone from Bioprojet for initiating narcolepsy drug phase 1 trial
Licensing deal, neurological, milestone payments, small molecule - Read more

Saya Biologics, Innovent Biologics collaborate to register and commercialize bevacizumab biosimilar in Mexico
Strategic collaboration, oncology, biosimilar, commercialization - Read more

Imugene, JW Therapeutics collaborate on onCARlytics and Carteyva combination for solid tumors
Co-development, oncology, oncolytic virus, cell therapy, solid tumors - Read more

JFCR, NEC, Taiho partner on shared neoantigen cancer vaccines using whole-genome information
Research collaboration, oncology, vaccine, AI/ML - Read more

Sanyou Bio, FatiAbGen partner on AI-driven drug discovery platform expansion in Korea and global markets
Strategic collaboration, AI/ML, drug discovery, antibody, R&D - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Valneva reports positive Ph2 results for VLA15 Lyme disease vaccine candidate showing strong immune response
Vaccine, infectious disease, Lyme disease, booster dose, bacterial infection - Read more

Zhongmou's ZM-02 optogenetic gene therapy shows vision improvements in Ph1 trial for advanced retinitis pigmentosa
Gene therapy, neurological, optogenetic therapy, retinitis pigmentosa, orphan drug designation - Read more

Gan & Lee initiates Ph3 trial for once-monthly bofanglutide GLP-1 receptor agonist targeting obesity in China
Protein therapy, metabolic, GLP-1 receptor agonist, obesity, once-monthly dosing - Read more

Kelun-Biotech's sacituzumab tirumotecan TROP2 ADC shows 31% response rate in Ph2 urothelial carcinoma study
Antibody, cancer, antibody-drug conjugate, urothelial carcinoma, TROP2 target - Read more

THE GOOD
Fundraises

Tempest raises $8.35M registered direct offering, clinical-stage cancer therapeutics development
Cancer, clinical-stage, immune-mediated therapeutics, first-in-class - Read more

Enlivex Therapeutics raises $212M private placement, macrophage immunotherapy company launching prediction markets strategy
Clinical-stage, immunotherapy, macrophage reprogramming, blockchain integration - Read more

Kane Biotech raises $800K private placement, developing biofilm-disrupting wound care treatments
Wound care, biofilm disruption, antimicrobial - Read more

Cormorant Asset Management to raise $400M fund, biotech/healthcare investment focus
Investment firm, biotech investor, healthcare fund, diversified portfolio - Read more

THE GOOD
Market Reports

AI-native biotechs raise funds at double valuations compared to traditional biopharma companies
AI-enabled drug discovery, strategic, investment, venture capital - Read more

THE GOOD
Regulatory

Novo Nordisk submits Wegovy (semaglutide) 7.2-mg dose application for obesity using priority voucher for expedited FDA review
Small molecule, metabolic, GLP-1 receptor agonist, obesity, semaglutide - Read more

Shanghai launches regulatory reforms to accelerate biomedical development with faster approvals and pilot programmes
Regulatory, strategic, operational, investment - Read more

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THE BAD
Approvals & Labels

FDA delays Ascendis Pharma's TransCon CNP achondroplasia approval decision by three months to February 2026
Protein therapy, rare disease, CNP analog, achondroplasia, dwarfism, pediatric population - Read more

THE BAD
Clinical Trials

Kallyope terminates Ph2 study of K-645 migraine drug after interim analysis shows unlikely efficacy success
Small molecule, neurological, migraine, TRPM8 inhibitor - Read more

BiomX's BX004 Ph2b trial in cystic fibrosis faces FDA clinical hold over nebulizer device concerns
Phage therapy, respiratory, bacteriophage cocktail, cystic fibrosis, Pseudomonas aeruginosa - Read more

THE BAD
Layoffs

Valneva shuts Nantes site, eliminates 30 jobs while consolidating operations in Lyon
Vaccine, infectious disease, operational, cost reduction - Read more

THE BAD
Mergers & Acquisitions

Lundbeck abandons Avadel pursuit after Alkermes raises bid to $21 per share plus CVR
GABAB agonist, sleep disorders, strategic, major transaction - Read more

THE BAD
Regulatory

India rejects Hetero Labs' generic HIV drug proposal, delaying lenacapavir access for millions
Small molecule, infectious disease, regulatory, operational - Read more

FDA delays Vanda's tradipitant clinical hold re-review to December 5 due to personnel transitions
Small molecule, gastrointestinal, regulatory, operational - Read more

FDA to tighten vaccine regulation after analysis links COVID-19 shots to 10 child deaths
mRNA vaccine, infectious disease, regulatory, operational - Read more

THE UGLY
Lawsuits

Sanofi headquarters raided by French authorities in tax fraud probe involving Société Générale loan
Legal, tax fraud investigation, operational, financial - Read more

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

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