All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
Scholar Rock's Isembyld (apitegromab) wins FDA approval for spinal muscular atrophy following Ph3 success
Antibody, neurological, monoclonal antibody, spinal muscular atrophy, myostatin inhibitor - Read more
FDA expands Pharming's Joenja (leniolisib) label to children aged 4+ with activated phosphoinositide 3-kinase delta syndrome
Small molecule, autoimmune, PI3Kδ inhibitor, activated phosphoinositide 3-kinase delta syndrome, pediatric patients - Read more
FDA approves Telix Pharmaceuticals' Pixclara (floretyrosine F 18) for PET imaging of glioma in adults and pediatric patients
Radiopharmaceutical, cancer, PET imaging, glioma, brain cancer diagnostics - Read more
THE GOOD
Business Development & Partnerships
Johnson & Johnson to sell orthopedics unit DePuy Synthes to Apollo Equity Management in $20B deal
Divestiture, orthopedics, medtech, private equity, equity investment - Read more
Bio Usawa, Axmed partner to expand affordable biologic medicines access across Africa
Strategic collaboration, biosimilars, ophthalmology, digital health, manufacturing, commercialization - Read more
Vezeeta, EVA Pharma partner to expand digital care access for obesity and diabetes patients in Egypt
Strategic collaboration, obesity, diabetes, digital health, telehealth - Read more
Owkin licenses K Pro AI scientist and multimodal data to Servier to advance oncology research
Licensing deal, oncology, AI/ML, drug discovery, multimodal data - Read more
Glafabra Therapeutics, Medical College of Wisconsin sign exclusive patent license for lentiviral vector transfer plasmid technology
Licensing deal, rare disease, gene therapy, manufacturing, lentiviral vector - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
Johnson & Johnson's Rybrevant (amivantamab) achieves longest overall survival in Ph3 trial for EGFR exon 20 insertion-positive non-small cell lung cancer
Antibody, cancer, bispecific antibody, non-small cell lung cancer, EGFR exon 20 insertion, combination therapy - Read more
Teitur Trophics reports positive Ph1 data for TT-P34 (TT-P34) targeting lysosomal pathway in Parkinson's disease
Protein therapy, neurological, peptide, Parkinson's disease, mitochondrial dysfunction, lysosomal pathway - Read more
Definium Therapeutics' DT120 (lysergic acid diethylamide) meets Ph3 primary endpoint for generalized anxiety disorder, advancing toward FDA submission
Small molecule, neurological, LSD, generalized anxiety disorder, psychedelic therapy - Read more
Cullinan Therapeutics, Taiho Oncology's (zipalertinib) combo shows 6-month survival benefit in Ph3 epidermal growth factor receptor exon 20 insertion mutation-positive non-small cell lung cancer
Small molecule, cancer, tyrosine kinase inhibitor, non-small cell lung cancer, EGFR exon 20 insertion, combination therapy - Read more
GSK, Hansoh Pharmaceutical's (risvutatug rezetecan) cuts death risk 54% in Ph3 relapsed small-cell lung cancer trial
Antibody-drug conjugate, cancer, small cell lung cancer, B7-H3 target, second-line treatment - Read more
BioNTech's (gotistobart) shows 18.5-month median overall survival in Ph3 relapsed metastatic squamous non-small cell lung cancer
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, CTLA-4, immune checkpoint inhibitor - Read more
GSK plans FDA label expansion bid for Jideytro (zidesamtinib) in first-line ROS1-positive non-small cell lung cancer
Small molecule, cancer, tyrosine kinase inhibitor, non-small cell lung cancer, ROS1 - Read more
Roche, MediLink's (tambotatug pelitecan) B7-H3 antibody-drug conjugate hits Ph3 primary endpoint in small cell lung cancer
Antibody-drug conjugate, cancer, small cell lung cancer, B7-H3, ADC safety - Read more
Summit Therapeutics, Akeso's ivonescimab cuts death risk 27% versus Keytruda in Ph3 front-line non-small-cell lung cancer
Antibody, cancer, bispecific antibody, non-small cell lung cancer, PD-1/VEGF, pembrolizumab - Read more
AstraZeneca's Tagrisso (osimertinib) shows 47–48% death risk reduction at eight-year Ph3 follow-up in early-stage epidermal growth factor receptor-mutated non-small cell lung cancer
Small molecule, cancer, EGFR inhibitor, non-small cell lung cancer, adjuvant therapy, overall survival - Read more
THE GOOD
Fundraises
Shennon Biotechnologies raises $12M, advancing T-cell engager programs toward clinical development
Immuno-oncology, T-cell engager, AI/ML platform, antibody, preclinical - Read more
Athernal Bio receives £700K ($946.9K) Innovate UK grant to expand operations and R&D efforts
Cancer interception, immunotherapy, hematology, preclinical - Read more
THE GOOD
Marketing
Novo Nordisk rebrands to Novo, repositions amid GLP-1 market struggles against Eli Lilly
Small molecule, metabolic disease, strategic, competitive, financial - Read more
THE GOOD
Mergers & Acquisitions
GE HealthCare to acquire Sofie Biosciences for up to $1B, boosting pharma diagnostics business
Radiopharmaceutical, oncology, major transaction, strategic - Read more
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❌ The Bad News ❌
THE BAD
Clinical Trials
AstraZeneca's Etcamah (camizestrant) Ph3 trial fails in frontline estrogen receptor-positive, HER2-negative advanced breast cancer
Small molecule, cancer, oral SERD, breast cancer, ESR1 mutation, CDK4/6 inhibitor - Read more
AstraZeneca, Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) Ph3 data show survival concerns in first-line HER2-mutant non-small cell lung cancer
Antibody-drug conjugate, cancer, non-small cell lung cancer, HER2, Enhertu, combination therapy - Read more
THE BAD
Layoffs
GSK to close Dresden vaccine manufacturing facility by mid-2027, affecting 640 workers
Vaccine manufacturing, infectious disease, operational, cost reduction - Read more
THE BAD
Regulatory
FDA delays decision on Exelixis's zanzalintinib (zanzalintinib) plus Roche's Tecentriq for metastatic colorectal cancer to March 2027
Small molecule, cancer, kinase inhibitor, colorectal cancer, combination therapy, PD-L1 - Read more
THE BAD
Strategic Plans
Cellectis scraps allogeneic CAR-T programs lasme-cel and eti-cel amid in vivo competition surge
Allogeneic CAR-T, oncology, strategic, competitive, cost reduction - Read more
You’re all caught up on the latest Pharma & Biotech News!
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