Radioligands

Novartis temporarily suspended the production of the company’s Lutathera and Pluvicto cancer therapies at facilities in Italy and New Jersey after potential quality issues were discovered in their manufacturing.

May 5, 2022/by Reuters Health

FDA Approves First Targeted Radioligand Therapy for Advanced Prostate Cancer

Approvals, Biomarkers, Clinical Trials, FDA, First-In-Class, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Novartis, Prostate gland13, R&D, Radioligands, Therapeutics

Novartis’ proposed drug for adults diagnosed with a certain type of advanced prostate cancer was given the green light for commercialization.

March 24, 2022/by BioSpace

Novartis’ Radioligand Therapy Excels in Phase III Prostate Cancer Trial

Clinical Trials, R&D, Radioligands

Targeted radioligand therapy 177Lu-PSMA-617 from Novartis significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer, according to findings from the Phase III VISION trial.

March 23, 2021/by Andrew Humphreys

Top 10 Pipelines To Watch: 2019 Annual Report

Analysts, Ankylosing Spondylitis (AS), Annual Reports, Antiretroviral Drugs, Atopic Dermatitis (Eczema), Autoimmune Diseases, B Cells, Big Pharma, Biologics, Biopharma, Biotechnology, Blockbusters, BRCA Gene, BRCA mutation, Breakthrough Therapy Designation, Business, Cancer, CAR-T Therapy, Cells, Chemotherapy, Clinical Data, Clinical Trials, Collaborations, Crohn's Disease, Cystic Fibrosis, Drug Discovery, EU, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, February 2019, Future Blockbusters, Gene Editing, Generalized Myasthenia Gravis (gMG), Genomics, HIV, Human Genome, Immune Cells, Immune System, Immune-Mediated Diseases, Immunotherapy, Inflammatory Diseases, Injectables, Innovation, Integrase strand transfer inhibitors, Issue Archives, Japan, M&A, Med Ad News, Monoclonal Antibodies, Multiple myeloma, Neoantigens, Neurology, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Non-Small Cell Lung Cancer (NSCLC), Nonalcoholic Steatohepatitis (NASH), Nuclear Medicine, Oncology, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Precision Medicine, Prescription Drug User Fee Act (PDUFA), Priority Medicines (PRIME) Designation, Priority Review Voucher, Product Pipelines, Proteins, Psoriatic Arthritis, R&D, Radioligands, Rare Disorders, Research, Rheumatoid Arthritis, RNA Interference (RNAi), Sickle Cell Disease, Small Molecules, Special Reports, T-Cells, Top 10 Pipelines, Top 10 Pipelines To Watch, Tumors, Ulcerative Colitis, Ultra Rare Diseases

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

February 13, 2019/by Andrew Humphreys

Novartis plans for 60 regulatory filings during 2019-2021

Asthma, Blockbusters, Chronic Lymphocytic Leukemia (CLL), European Medicines Agency, FDA, Multiple Sclerosis, Neovascular Age-Related Macular Degeneration (nAMD), Potential Blockbusters, Product Launches, Product Pipelines, Radioligands, Research & Development, Spinal Muscular Atrophy (SMA)

Swiss pharma giant Novartis announced plans to seek regulatory approval for 60 new treatments between 2019 and 2021.

November 5, 2018/by BioSpace