Temporal Concept
Roche’s Alecensa Gains FDA Approval for Postsurgical Early Lung Cancer Treatment
Roche, Alecensa, FDA approval, Postsurgical treatment, Early lung cancer
Cerevel Reports Phase 3 Parkinson’s Study Success Amidst AbbVie Acquisition
Cerevel Therapeutics, Phase 3 Parkinson’s disease trial, Tavapadon, AbbVie acquisition, Successful clinical trial results
Director/Vice President of Translational Research: Leading the Bridge from Discovery to Clinical Development
Translational Research, Biomarker Discovery, Preclinical Development, Early Clinical Development, Drug Molecule Development, Translational Science Leadership, Biomarker Development, Target Engagement Strategies, Assay Development (PK/ PD/ Immunogenicity), Clinical Trial Design, Endpoint and Biomarker Strategy, Team Building and Leadership, Cross-Functional Collaboration, Regulatory Approvals
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Amylyx Reveals Interim Rare Disease Data for Withdrawn ALS Therapy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