Intellectual Product
FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months
FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval
No Recent News Specifically About ‘Click here to continue reading’
click here to continue reading; news; recent news; web navigation; internet phrase
Endpoints News Launches Industry Sentiment Survey, But No Evidence Yet of a New Biopharma Sentiment Index
Endpoints News; biopharma; sentiment; survey; industry trends; John Carroll
FDA Launches Pilot Program to Prioritize U.S. Generic Drug Manufacturing and Testing
FDA; pilot program; generic drugs; ANDA prioritization; domestic manufacturing; bioequivalence testing; U.S. pharmaceutical supply chain; drug approval; supply chain resilience
Meeting on the Mesa 2025 Arrives Amid Mixed Signals for Cell and Gene Therapy Sector
Cell and gene therapy; Meeting on the Mesa; Commercialization; Clinical trials; Advanced therapies; Industry partnerships; Regulatory challenges; Phoenix Arizona; mRNA; Gene editing; Alternative payment models
Trump Administration and Pfizer Strike ‘Most Favored Nation’ Drug Price Deal
Trump; Pfizer; most favored nation; drug prices; Medicaid; TrumpRx; direct-to-consumer; pharmaceutical industry; PhRMA; AmericasMedicines.com
Trump Administration Pauses Pharmaceutical Tariffs to Negotiate Industry Agreements
Trump; pharmaceutical tariffs; tariff pause; drug pricing; domestic manufacturing; Section 232 investigation; branded drugs; patented drugs
Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe
Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA
Sanofi Expands $35 Insulin Program to All U.S. Patients Nationwide
Sanofi; Insulin; $35 monthly program; Insulins Valyou Savings Program; diabetes; insurance coverage; Medicare; affordability; United States