regulatory – Page 5

Navigating Challenges and Opportunities in the 2024 Life Sciences Industry Outlook

1 year ago talkbio0Tagged Artificial Intelligence, Attitude, Biotechnology, Changing, drug price, Life Sciences Industry, regulatory, shortage, Supply Chain Security, Talent

Life Sciences Industry, 2024 Outlook, Biotechnology, Medical Devices, Artificial Intelligence, Drug Pricing, Regulatory Changes, Supply Chain Security, Talent Shortage

Novo Nordisk Withdraws FDA Submission for Wegovy’s Heart Failure Indication, Plans to Reapply Next Year

1 year ago talkbio0Tagged expansion, Heart failure, Labels (device), Nordisk, regulatory, Submission, United States Food and Drug Administration, Wegovy

Novo Nordisk, Wegovy, FDA submission, heart failure, label expansion, regulatory delay

Supreme Court Overturns Chevron Doctrine, Limiting FDA’s Regulatory Authority

1 year ago talkbio0Tagged Administrative action, Agencies, Chevron doctrine, court, Interpretation Process, regulatory, statutory ambiguity, Supreme, United States Food and Drug Administration

Chevron doctrine, FDA, regulatory authority, Supreme Court, administrative law, agency interpretations, statutory ambiguity

Innovent to Submit IL-23 Psoriasis Drug to Chinese Regulators Following Phase 3 Success

1 year ago talkbio0Tagged China, CLEAR-1, Clinical Research, Dental Plaque, Innovent, interleukin-23, picankibart, Psoriasis, regulatory

Innovent, IL-23, psoriasis, picankibart, phase 3, China, regulatory submission, plaque psoriasis, CLEAR-1 study

Novartis Achieves Success in Two Phase III Trials for Rare Kidney Diseases, Eyes Regulatory Submissions

1 year ago1 year ago talkbio0Tagged C3 glomerulopathy, IGA Glomerulonephritis, Infrequent, Novartis, Phase 3 Clinical Trials, regulatory, submissions

Novartis, Phase III trials, Rare kidney diseases, IgA nephropathy, C3 glomerulopathy, Regulatory submissions

FDA Revokes Accelerated Approval of Helsinn’s Cancer Drug at Company’s Request

1 year ago talkbio0Tagged Accelerated, Antineoplastic Agents, Approved, Clinical Trials, Helsinn, patient safety, regulatory, United States Food and Drug Administration

FDA, Helsinn, accelerated approval, cancer drug, company request, drug withdrawal, regulatory decision, clinical trials, patient safety.

Revolutionizing Healthcare: Streamlining Cell and Gene Therapy Manufacturing (Part 1)

1 year ago talkbio0Tagged Biotechnology, Cell Therapy, Cost Effectiveness, gene therapy, healthcare innovation, Manufacture, Precision Medicine, production, regulatory, scalability

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

1 year ago talkbio0Tagged Automation, biomanufacturing, CAR-T, Cell Therapy, gene therapy, Manufacture, Precision Medicine, regulatory, scale-up, Stem Cell Therapy, Viral Vector

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.