Intellectual Product – Page 2

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

2 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

Meeting on the Mesa 2025 Arrives Amid Mixed Signals for Cell and Gene Therapy Sector

2 weeks ago talkbio0Tagged Advanced therapies, Alternative, Cells, Clinical Trials, commercialization, Gene Modification, gene therapy, Industry, meeting, MESA, partnerships, payment, Phoenix Arizona, regulatory challenges, RNA, Messenger, Study models

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

2 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

Trump Administration Pauses Pharmaceutical Tariffs to Negotiate Industry Agreements

2 weeks ago talkbio0Tagged branded drugs, domestic manufacturing, drug price, Evaluation, patented drugs, pharmaceutical tariffs, Sectioning technique, tariff pause, Transplant Registry Unified Management Program

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

3 weeks ago talkbio0Tagged Biological Factors, Biosimilars, CDMO, Contract agreement, Digital innovation, Europe, Gdańsk, Guanosine Monophosphate, Manufacturing, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Rezon Bio, United States Food and Drug Administration, Warsaw-Duchnice

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

3 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

3 weeks 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 weeks 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

Sanofi Injects $625M Into Biotech Investment Arm to Accelerate Innovation

3 weeks ago talkbio0Tagged Cash, cell/gene therapy, digital health, expansion, Immunology, Infrequent, Infusion procedures, Investments, Neurology speciality, portfolio, sanofi, Sanofi Ventures, venture capital

Sanofi; Sanofi Ventures; biotech investment; $625M cash infusion; digital health; immunology; rare diseases; neurology; venture capital; cell/gene therapy; portfolio expansion

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

3 weeks ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission