Regulation or Law

FDA names Tracy Beth Heg as acting CDER chief

1 week ago talkbio0Tagged CDER, Center for Drug Evaluation, Chief, COVID19 (disease), Drug Regulations, Leadership, research, Tracy Beth Heg, U.S. Food and Drug Administration, United States Food and Drug Administration, Vaccine Safety

Tracy Beth Heg; acting CDER chief; FDA leadership; Center for Drug Evaluation and Research; COVID-19 vaccine safety; drug regulation; U.S. Food and Drug Administration

Top Drug Regulator Richard Pazdur to Retire from FDA Amid Industry Concerns

1 week ago talkbio0Tagged Center for Drug Evaluation, Drug Regulations, Leadership, Personnel Turnover, research, Retirement, Richard Pazdur, United States Food and Drug Administration

Richard Pazdur; FDA; retirement; Center for Drug Evaluation and Research; drug regulation; Marty Makary; leadership turnover

Recent Developments in Medical Affairs Reputation and Hemophilia A Management in the US (2025)

2 weeks ago talkbio0Tagged Acquired (qualifier value), Centers for Disease Control and Prevention (U.S.), federal funding, gene therapy, Health Policy, Hemophilia A, Hemophilia A Pipeline, Hemophilia Treatment Centers, HRSA, Medical Affairs, Programs - Publication Format, public health policy, reputation, U.S.

Medical Affairs; Reputation; Hemophilia A; US; 2025; Gene Therapy; Public Health Policies; Hemophilia Treatment Centers; 340B Program; Federal Funding; Acquired Hemophilia A Pipeline; Healthcare Policy; CDC; HRSA

CMS Unveils Negotiated Prices for Ozempic, Wegovy, and Other Drugs in Second Round of IRA Talks

2 weeks ago talkbio0Tagged drug price, Effectiveness, Inflation Reduction Act, Medicare Part D, Myasthenic Syndromes, Congenital, negotiation, Ozempic, Prices, semaglutide, Wegovy

CMS; Ozempic; Wegovy; Inflation Reduction Act; drug price negotiation; Medicare Part D; semaglutide; negotiated prices; 2027 effective date

Scott Gottlieb, M.D., Joins UnitedHealth Group Board of Directors

3 weeks ago talkbio0Tagged board of directors, Health care facility, Health Policy, innovation, medical breakthroughs, Patient access, Scott Gottlieb, Technology, United States Food and Drug Administration, UnitedHealth Group

Scott Gottlieb; UnitedHealth Group; Board of Directors; FDA; health policy; innovation; patient access; medical breakthroughs; technology in healthcare

Navigating JPM 2026: Biotech/Biopharma Trends, Policy Impacts, and Forward Outlook

3 weeks ago talkbio0Tagged Biopharma, dealmaking, Drug Discovery, financing strategy, Health Policy, innovation, JPM, trends qualifier

JPM 2026; biotech trends; biopharma trends; healthcare policy; AI in drug discovery; financing strategy; dealmaking; innovation

US Government Shutdown Threatens to Stress an Already Depleted FDA

2 months ago talkbio0Tagged delays, Drug Approval, federal funding, Government Shutdown, public health medicine (field), regulatory, Staff, Surgical aspects, United States Food and Drug Administration, user fees

Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays

Glenmark Pharma Signs $1.1 Billion Deal with Hengrui for HER2-Targeted Antibody-Drug Conjugate

3 months ago talkbio0Tagged Cancer Therapeutic Procedure, Glenmark, Hengrui Pharma, HER2-targeting antibody drug conjugate, License, milestone payments, Neoplasms, royalties, Trastuzumab Rezetecan

Glenmark; Hengrui Pharma; Trastuzumab Rezetecan; HER2-targeting antibody drug conjugate; oncology; exclusive license; $1.1 billion deal; cancer therapy; milestone payments; royalties

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

3 months ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

ICER Draft Report: High-Cost GLP-1 Obesity Drugs Deemed Cost-Effective—Affordability Still a Concern

3 months ago talkbio0Tagged Affordability, cardiovascular benefits, Cost-Effectiveness, CREM gene, Glucagon-Like Peptide 1, Health Policy, Obesity, semaglutide, tirzepatide, value-based pricing

ICER; GLP-1; semaglutide; tirzepatide; obesity drugs; cost-effectiveness; health policy; affordability; value-based pricing; cardiovascular benefits