Governmental or Regulatory Activity – Page 3

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

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

1 month 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

1 month 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

1 month 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

1 month 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

2 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

Trump Administration Weighs Severe Restrictions on US Pharmas Licensing Chinese Medicines

2 months ago talkbio0Tagged AstraZeneca, chinese medicine, Drug Industry, drug manufacturing, executive order, licensing restrictions, lobbying, National Security, Pfizer, Transplant Registry Unified Management Program, United States Food and Drug Administration

Trump administration; Chinese medicines; executive order; pharmaceutical industry; licensing restrictions; national security; lobbying; Pfizer; AstraZeneca; biotech; drug manufacturing; FDA review