Intellectual Product

FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews

1 day ago talkbio0Tagged Accelerated, CNPV, domestic drug manufacturing, Drug Approval, Martin Makary, National Priority Voucher, pilot program, Priority Review, public health crisis, recipients, United States Food and Drug Administration

FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing

CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz

1 day ago talkbio0Tagged Autoimmune thrombocytopenia, belumosudil, cGVHD, CHMP, chronic graft-versus-host disease, Clinical Data, Inosine Triphosphate, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, regulatory approval, Rezurock, Rilzabrutinib, sanofi, Wayrilz

Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data

EMD Serono Joins TrumpRx in Affordability Push; Roche Launches DTC Program

2 days ago talkbio0Tagged Affordability, CNPV, direct-to-consumer sales, Ditiocarb, Electromechanical dissociation, Fertility Agents, Fertilization in Vitro, Pergoveris, Programs - Publication Format, Roche (company), serono, tariffs, TrumpRx, White House Executive Order

EMD Serono; TrumpRx; IVF therapies; affordability; fertility drugs; Direct-to-Consumer sales; Roche; DTC program; White House Executive Order; Section 232 tariffs; CNPV program; Pergoveris

White House Announces New Most-Favored Nation Drug Pricing Deal, Updates on FDA Vouchers and GLP-1 Negotiations

2 days ago talkbio0Tagged AstraZeneca, drug price, Electromechanical dissociation, Fertility Agents, Fertilization in Vitro, Glucagon-Like Peptide 1, Medicaid, Most-Favored-Nation, Pfizer, Pricing, serono, Trump administration, United States Food and Drug Administration, Voucher

most-favored nation pricing; fertility drugs; IVF; Trump administration; drug pricing; Medicaid; FDA vouchers; GLP-1; EMD Serono; Pfizer; AstraZeneca

Ex-FDA Leaders Launch Canal Row Advisors, Offer Insights on Agency’s Challenges and Direction

3 days ago talkbio0Tagged Biological Science Disciplines, Canal Row Advisors, innovation, Leadership, Michael Rogers, Policy, public health medicine (field), reform, regulatory consulting, regulatory strategy, United States Food and Drug Administration

Canal Row Advisors; FDA leadership; regulatory consulting; Michael Rogers; Hilary Marston; life sciences; regulatory strategy; public health; FDA reform; innovation policy

BioCryst Snaps Up Fellow Angioedema Player Astria for $700M

4 days ago talkbio0Tagged Acquisition, Angioedemas, Hereditary, Astria, BioCryst, Cash, Drug Industry, navenibart, Rare Diseases

BioCryst; Astria Therapeutics; acquisition; hereditary angioedema (HAE); navenibart; rare disease; pharmaceutical industry; cash and stock deal; Jill Milne; $700 million

No Trump Drug Pricing Plan for J&J—Yet

5 days ago talkbio0Tagged drug pricing plan, J&J, Transplant Registry Unified Management Program

J&J; Trump; Drug Pricing Plan

FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

5 days ago talkbio0Tagged Accelerated, Alfa, amendment, Approved, Biologics License Application, Clinical pharmacology discipline, Deferred, Denali, Mucopolysaccharidosis II, review extension, tividenofusp, United States Food and Drug Administration

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval