Temporal Concept
Novartis’ Fabhalta (Iptacopan) Receives FDA Priority Review for IgA Nephropathy (IgAN) Treatment
Novartis, Fabhalta, Iptacopan, IgA Nephropathy (IgAN), FDA Priority Review, Phase 3 Data
The Transformative Future of Specialist Distribution: Adaptive Strategies and Technological Innovations
Specialist Distribution, Future Trends, Adaptive Strategies, Technological Innovations, Automation, Artificial Intelligence, Last-Mile Solutions, Virtual Distribution, Data Integration, Global Expansion, Smart Distribution Centers
Amylyx Reveals Interim Rare Disease Data for Withdrawn ALS Therapy
Amylyx, Rare disease data, ALS drug withdrawal, Interim results, Rare neurological disorder
AstraZeneca and Daiichi Sankyo’s Enhertu Wins Historic FDA Approval as First Tumor-Agnostic HER2-Directed Therapy
Enhertu, AstraZeneca, Daiichi Sankyo, FDA Approval, Tumor-Agnostic, HER2-Directed Therapy, Metastatic HER2-Positive Solid Tumors, Accelerated Approval, DESTINY-PanTumor02 Study, Objective Response Rate (ORR), Duration of Response (DoR)
AstraZeneca’s Lynparza Demonstrates Nearly 50% Response in Advanced Breast Cancer Patients: #AACR24 Update
AstraZeneca, Lynparza (olaparib), PARP inhibitor, Advanced breast cancer, 50% response rate, AACR24
Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections
Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US
Vanda’s Fanapt Secures Second FDA Approval for Treating Bipolar I Disorder
Fanapt, Vanda Pharmaceuticals, Bipolar I Disorder, Second FDA Nod, Iloperidone, Acute Treatment of Manic or Mixed Episodes
Acorda Therapeutics Concludes $185M Asset Sale with Merz amid Bankruptcy Filing Following Disappointing Sales
Acorda Therapeutics, $185M asset sale, Merz, Bankruptcy filing, Years of disappointing sales, Multiple Sclerosis drug Fampyra, Biogen returns ex-US rights, Generic competition, Declining sales, Neurological diseases
Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges
Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development
AstraZeneca’s Ultomiris Gains FDA Approval for Rare Autoimmune Condition – NMOSD
AstraZeneca, Ultomiris, ravulizumab-cwvz, FDA Approval, Rare Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD), Long-acting C5 complement inhibitor, Phase 3 CHAMPION-NMOSD Trial, Reduced Relapse Rate, Dosing Frequency