Regulation or Law
SEC Staff Recommends Enforcement Action Against Allarity Over Potential Federal Securities Laws Violations
Allarity Therapeutics, SEC, Enforcement Action, Federal Securities Laws, Violations, Wells Notice, FDA, Dovitinib, Stenoparib
House Speaker Plans Vote on Biosecure Act Amid Broader China Legislation Push
House Speaker, Biosecure Act, China Legislation, National Security, Biotech Companies
Medicare Drug Price Negotiation Program Upheld in Court, Defeating Boehringer Ingelheim’s Challenge
Medicare, drug pricing, negotiation program, Boehringer Ingelheim, legal challenge, pharmaceutical industry, healthcare policy
Supreme Court Overturns Chevron Doctrine, Limiting FDA’s Regulatory Authority
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
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
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
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.