Governmental or Regulatory Activity – Page 4

US Government Shutdown Threatens to Stress an Already Depleted FDA

3 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

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

3 months 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

3 months 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

3 months 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

3 months 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

AstraZeneca Appeals to Supreme Court in Final Attempt to Challenge Medicare Drug Price Negotiation Program

3 months ago talkbio0Tagged AstraZeneca, drug price, Farxiga, Inflation Reduction Act, Medicare, Myasthenic Syndromes, Congenital, Negotiation Program, Supreme Court

AstraZeneca; Medicare Drug Price Negotiation Program; Supreme Court; Inflation Reduction Act; Third Circuit; due process; pharmaceuticals; CMS; drug pricing; Farxiga

Getting to Yes: How Deal-Making Fuels Biotech Growth – 2025 Updates

3 months ago talkbio0Tagged Acquisitions, BATNA, biotech dealmaking, Licensing, mergers, patent cliffs, pharmaceutical negotiations, pipeline gaps, regulatory uncertainty, reputation, valuation, venture capital

biotech dealmaking; mergers and acquisitions; licensing; venture capital; BATNA; pharmaceutical negotiations; reputation; pipeline gaps; patent cliffs; valuation; regulatory uncertainty

FDA Rejects Lundbeck and Otsuka’s Rexulti for PTSD on Insufficient Efficacy Evidence

3 months ago talkbio0Tagged brexpiprazole, Clinical Trials, Complete, Drug Approval, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Response Letter, Rexulti, sertraline, sNDA, United States Food and Drug Administration

FDA; Rexulti; Lundbeck; Otsuka; PTSD; brexpiprazole; sertraline; Complete Response Letter; sNDA; clinical trials; drug approval

FDA Rejects Scholar Rock’s SMA Drug Due to Catalent Indiana Manufacturing Issues

3 months ago talkbio0Tagged apitegromab, Catalent Indiana, Complete, Drug Approval, manufacturing issues, Response Letter, Scholar Rock, SMA, Spinal Muscular Atrophy, United States Food and Drug Administration

FDA; Scholar Rock; Apitegromab; SMA; Spinal Muscular Atrophy; Catalent Indiana; Complete Response Letter; Manufacturing issues; Drug approval

Eli Lilly Loses Appeal to Overturn $183.7 Million Medicaid Rebate Judgment

3 months ago talkbio0Tagged appeal, Circuit, court, drug price, eli lilly, False Claims Act, Fraud, judgment, Medicaid, Positive

Eli Lilly; Medicaid; rebate; court ruling; False Claims Act; drug pricing; whistleblower; 7th Circuit Court of Appeals; fraud; $183.7 million judgment