Regulation or Law
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)
Sanofi Settles 4,000 Zantac Cancer Lawsuits, Faces Delaware Claims
Sanofi, Zantac, Cancer Lawsuits, Settlement, Delaware Claims, 4/000 Lawsuits, Delaware Superior Court, Daubert Ruling
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.
BeiGene Scores Two Major FDA Approvals – Trivimbra for Esophageal Cancer and Brukinsa for Follicular Lymphoma
BeiGene, Trivimbra (tislelizumab), Esophageal Cancer, Brukinsa (zanubrutinib), Follicular Lymphoma, FDA Approval, Accelerated Approval, Obinutuzumab