Governmental or Regulatory Activity – Page 3

AstraZeneca Reaches Drug Pricing Deal with White House, Becomes Second Pharma to Do So

2 months ago talkbio0Tagged AstraZeneca, drug discounts, drug price, Medicaid, most-favored-nation pricing, Pfizer, tariffs, TrumpRx, White House

AstraZeneca; White House; drug pricing; Medicaid; TrumpRx; most-favored-nation pricing; tariffs; Pfizer; drug discounts

FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval

2 months ago talkbio0Tagged 2025, CBER, CDER, Drug Approval, molecular entities, trends qualifier, United States Food and Drug Administration

FDA; drug approvals; 2025; new molecular entities; CDER; CBER; trends; novel drugs

Biopharma Deal Activity Shows Uptick in Q3 2025: Signs of Recovery and Emerging Trends

2 months ago talkbio0Tagged assets, Biopharma, China, Early-stage, Europe, Licensing, M&A, Merus, Metsera, Physical activity, Q3, therapeutic diversification, U.S., Verona Pharma

biopharma; Q3 2025; deal activity; M&A; licensing; therapeutic diversification; early-stage assets; China; US; Europe; Metsera; Verona Pharma; Merus; high-value deals

Xspray’s Dasynoc Faces FDA Approval Delay Due to Contract Manufacturing Issues

2 months ago talkbio0Tagged Acute lymphocytic leukemia, Complete Response Letter, contract manufacturer, Dasynoc, Drug Approval Process, manufacturing issues, manufacturing practice, Myeloid Leukemia, Chronic, United States Food and Drug Administration, Xspray Pharma

Dasynoc; Xspray Pharma; FDA; Complete Response Letter; manufacturing issues; good manufacturing practice; contract manufacturer; chronic myeloid leukemia; acute lymphoblastic leukemia; drug approval process

Odyssey Therapeutics Appoints Pharmaceutical Leader Nia Tatsis, Ph.D., to Its Board of Directors

2 months ago talkbio0Tagged assurance, Autoimmune Diseases, Biological Factors, board of directors, Nia Tatsis, Odyssey Therapeutics, Quality, Regulatory Affairs, RIPK2 scaffolding inhibitor

Odyssey Therapeutics; Nia Tatsis; Board of Directors; Vertex Pharmaceuticals; RIPK2 scaffolding inhibitor; autoimmune diseases; biopharmaceuticals; regulatory affairs; quality assurance

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

2 months 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

2 months 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

2 months 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

2 months 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

2 months 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