Governmental or Regulatory Activity – Page 2

FDA Launches Pilot Program to Prioritize U.S. Generic Drug Manufacturing and Testing

3 weeks ago talkbio0Tagged ANDA, bioequivalence testing, domestic manufacturing, Drug Approval, Pharmaceutical Supply Chain, pilot program, Prioritization, resilience, supply chain, United States, United States Food and Drug Administration

FDA; pilot program; generic drugs; ANDA prioritization; domestic manufacturing; bioequivalence testing; U.S. pharmaceutical supply chain; drug approval; supply chain resilience

Recent Law Expands Orphan Drug Protections, Shielding Blockbusters from Medicare Price Negotiations

4 weeks ago talkbio0Tagged Big Beautiful Bill, Congress (U.S. Legislature), Drug Industry, drug price, Inflation Reduction Act, Keytruda, Medicare, negotiation, OBBBA, Opdivo, orphan drug exclusion

orphan drug exclusion; Medicare negotiation; One Big Beautiful Bill; Keytruda; Opdivo; Inflation Reduction Act; OBBBA; drug pricing; Congress; pharmaceutical industry

Trump Administration and Pfizer Strike ‘Most Favored Nation’ Drug Price Deal

4 weeks ago talkbio0Tagged AmericasMedicines.com, Direct-to-Consumer, Drug Industry, drug price, Medicaid, Nation, Pfizer, PhRMA, Transplant Registry Unified Management Program, TrumpRx

Trump; Pfizer; most favored nation; drug prices; Medicaid; TrumpRx; direct-to-consumer; pharmaceutical industry; PhRMA; AmericasMedicines.com

Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress

4 weeks ago talkbio0Tagged Clinical Trials, collaborative framework, Drug Approval, Employment Termination, Hetlioz, jet lag disorder, lawsuit, Motion Sickness, sNDA, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

4 weeks ago talkbio0Tagged biotech, Complete, CUTX-101, deficiencies, Drug Approval, Fortress, Infrequent, Manufacturing, Menkes disease, Pediatric Disorder, Sentynl Therapeutics, United States Food and Drug Administration

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback

US Government Shutdown Threatens to Stress an Already Depleted FDA

4 weeks 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

White House ‘Most Favored Nation’ Deadline Drives Pharma Concessions Amid Threats of Enforcement

4 weeks ago talkbio0Tagged deadline, drug manufacturers, drug price, Medicaid, Medicare, Nation, Pharma Concessions, pharmaceutical companies, prescription drug costs, Trump administration, White House

most favored nation; drug pricing; White House; executive order; pharmaceutical companies; Medicaid; Medicare; drug manufacturers; Trump administration; prescription drug costs; deadline; pharma concessions

Sanofi Expands $35 Insulin Program to All U.S. Patients Nationwide

4 weeks ago talkbio0Tagged Affordability, Diabetes, Insulin, Insurance, Medicare, monthly, Programs - Publication Format, sanofi, United States

Sanofi; Insulin; $35 monthly program; Insulins Valyou Savings Program; diabetes; insurance coverage; Medicare; affordability; United States

Trump Administration Teases MFN Drug Pricing Rule as Commitment Deadline Looms for Companies

1 month ago talkbio0Tagged Commitment Deadline, direct-to-consumer sales, drug price, executive order, international reference price, Medicaid, MFN, Most-Favored-Nation, Parity, pharmaceutical manufacturers, Prices, Pricing, tariffs, Transplant Registry Unified Management Program

Trump administration; Most-Favored-Nation (MFN) pricing; drug pricing; executive order; pharmaceutical manufacturers; Medicaid; direct-to-consumer sales; price parity; commitment deadline; tariffs; international reference price

Trump Administration Launches Tariff Probe into Medtech and Pharmaceutical Industries

1 month ago talkbio0Tagged Evaluation, Manufacturing, Medical Devices, medtech industry, National Security, pharmaceutical imports, Sectioning technique, semiconductor tariffs, supply chain, tariffs, Transplant Registry Unified Management Program

Trump administration; tariffs; medtech industry; pharmaceutical imports; Section 232 investigation; semiconductor tariffs; national security; supply chain; manufacturing; medical devices