Regulation or Law – Page 5

Navigating JPM Week 2024: Insights and Opportunities in Biopharma

10 months ago talkbio0Tagged Biopharma, deal-making, Industry, Investments, IPOs, JPM, M&A, Network, regulatory, trends qualifier

JPM Week 2024, Biopharma, Industry Insights, Networking, Deal-making, Investment, M&A, IPOs, Regulatory Trends

Biopharma Industry Braces for Uncertainty Under Trump’s Second Term: Impact on Vaccines and M&A Deals

10 months ago talkbio0Tagged Biopharma Industry, Changing, FTC, Health Policy, M&A, Policy, Regulation, second, Trump 's, United States Federal Trade Commission, Vaccines

Trump’s second term, Biopharma industry, Vaccine regulation, Robert F. Kennedy Jr., M&A deals, FTC policy changes, Healthcare policy uncertainty

GSK Advances Regulatory Filings for Linerixibat Following Successful Phase 3 Trial in PBC Itch Treatment

10 months ago talkbio0Tagged Cholestatic pruritus, Linerixibat, Phase 3 trial, Primary Biliary Cholangitis, Pruritus, regulatory, SmithKline Beecham

GSK, Linerixibat, PBC Itch, Phase 3 Trial, Regulatory Filings, Cholestatic Pruritus

Merck’s Subcutaneous Keytruda Shows Non-Inferiority in Phase 3 Trial, Paving Way for Regulatory Discussions

10 months ago talkbio0Tagged Immunotherapy for cancer, Keytruda, Merck, non-inferiority, Phase 3 trial, regulatory, subcutaneous, submissions

Merck, Keytruda, subcutaneous, cancer immunotherapy, phase 3 trial, non-inferiority, regulatory submissions

RFK Jr.’s HHS Nomination: A Potential Threat to the Biopharma Industry

10 months ago talkbio0Tagged Administration occupational activities, Biopharma, CHARGE Syndrome, Health Policy, Industry, nomination, RFK Jr., Skepticism, Transplant Registry Unified Management Program, Vaccines

RFK Jr., HHS nomination, biopharma industry, vaccine skepticism, health policies, Trump administration

GSK’s Blenrep Demonstrates Survival Advantage Over J&J’s Darzalex in Multiple Myeloma Treatment

10 months ago talkbio0Tagged belantamab, Blenrep, Darzalex, DREAMM-7, DREAMM-8, mafodotin, Multiple Myeloma, regulatory, SmithKline Beecham, Survival

GSK, Blenrep, Belantamab mafodotin, Multiple myeloma, DREAMM-7, DREAMM-8, Darzalex, Survival advantage, Regulatory challenges

Rapport Therapeutics Faces Regulatory Hurdles in Pain Treatment Trials

10 months ago talkbio0Tagged Clinical Development, RAP-219, Rapport Therapeutics, regulatory, treatment pain

Rapport Therapeutics, pain treatment trials, regulatory challenges, RAP-219, clinical development

Dr. Reddy’s Recalls Over 300,000 Bottles of Thyroid Medication Due to Carcinogen Contamination

10 months ago talkbio0Tagged adulteration, Carcinogens, Dr. Reddy 's, pharmaceutical safety, regulatory, Thyroid preparations, United States Food and Drug Administration

Dr. Reddy’s, thyroid drug recall, carcinogen contamination, pharmaceutical safety, FDA regulations

Lexicon’s Diabetes Drug Zynquista Faces FDA Scrutiny Again Ahead of Advisory Committee Meeting

11 months ago talkbio0Tagged Advisory Committees, Diabetes, lexicon, regulatory, United States Food and Drug Administration, Zynquista

Lexicon Pharmaceuticals, Zynquista, FDA, diabetes drug, advisory committee, regulatory challenges

Mitigating Risks in mRNA Manufacturing: Strategies for Smooth Transition from Preclinical to Clinical Stages

11 months ago talkbio0Tagged analytical method, Automation, bony process, clinical transition, Control Groups, Materials, Preclinical, Quality, regulatory, Risk Management, RNA, Messenger

mRNA manufacturing, risk management, preclinical to clinical transition, quality control, regulatory compliance, raw material selection, process automation, analytical methods.