Regulation or Law
FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request
FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.
Ex-Pharmaceutical Executive Receives Probation in Antitrust Violation Case
Pharmaceutical industry, antitrust violation, price-fixing, Sandoz, executive, sentencing, probation
Revolutionizing Healthcare: Streamlining Cell and Gene Therapy Manufacturing (Part 1)
Cell therapy, gene therapy, manufacturing, biotechnology, healthcare innovation, personalized medicine, production challenges, regulatory compliance, scalability, cost-effectiveness.
Revolutionizing Medicine: The Evolution and Future of Cell and Gene Therapy Manufacturing
Cell therapy manufacturing, gene therapy manufacturing, biomanufacturing, advanced therapies, CAR-T cell therapy, stem cell therapy, viral vectors, bioreactors, automation, scale-up, regulatory compliance, personalized medicine.
Revival of Gene Editing Clinical Trials in China Post CRISPR Baby Scandal
CRISPR baby scandal, China, gene editing, clinical trials, restart, regulations, ethics, CRISPR-Cas9, genetic diseases, biotechnology.
Novartis to Revise CRO Partnerships Amidst US Senate Bill Scrutiny
Novartis, CRO relationships, US Senate bill, Chinese companies, pharmaceutical industry, regulatory changes, partnership revisions
FTC’s Proposed Noncompete Ban: A Game Changer for Biopharma Job Mobility
FTC, Noncompete Ban, Biopharma Jobs, Job Mobility, Employee Rights, Competition Law
Landmark Federal Data Privacy Proposal Unveiled
Federal Data Privacy, Public Showcase, Proposal, Consumer Rights, Privacy Law
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
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)