Governmental or Regulatory Activity

Crescent Biopharma and Kelun-Biotech Announce Reciprocal Licensing Pact for PD-1xVEGF and ADC Cancer Therapies

5 days ago talkbio0Tagged Antibodies, Bispecific, China, CR-001, Crescent Biopharma, Kelun-Biotech, Licensing, oncology partnership, PD-1xVEGF, Reciprocal, SKB105, therapeutic autologous dendritic cells

Crescent Biopharma; Kelun-Biotech; PD-1xVEGF; CR-001; SKB105; reciprocal licensing; oncology partnership; China; ADC; bispecific antibody

Recent Developments in Medical Affairs Reputation and Hemophilia A Management in the US (2025)

1 week ago talkbio0Tagged Acquired (qualifier value), Centers for Disease Control and Prevention (U.S.), federal funding, gene therapy, Health Policy, Hemophilia A, Hemophilia A Pipeline, Hemophilia Treatment Centers, HRSA, Medical Affairs, Programs - Publication Format, public health policy, reputation, U.S.

Medical Affairs; Reputation; Hemophilia A; US; 2025; Gene Therapy; Public Health Policies; Hemophilia Treatment Centers; 340B Program; Federal Funding; Acquired Hemophilia A Pipeline; Healthcare Policy; CDC; HRSA

Pharma Faces Supreme Court Deadline as IRA Price Negotiation Takes Effect

2 weeks ago talkbio0Tagged AstraZeneca, Centers for Medicare & Medicaid Services, drug price, Farxiga, Inflation, Medicare, negotiation, petition, pharmaceutical lawsuits, price controls, SCOTUS, Supreme Court

Inflation Reduction Act; SCOTUS; drug price negotiation; AstraZeneca; Medicare; pharmaceutical lawsuits; Fifth Amendment; supreme court petition; Farxiga; Centers for Medicare & Medicaid Services; price controls

FDA’s Pazdur Raises Concerns Over Legality of National Priority Voucher Program Amid Internal Disagreement

2 weeks ago talkbio0Tagged CNPV, Commissioner 's National Priority Voucher, Drug Approval Process, internal disagreement, legality, Pazdur, Tidmarsh, Tumor board, United States Food and Drug Administration

FDA; Pazdur; Commissioner’s National Priority Voucher; CNPV; legality; internal disagreement; tumor board; Tidmarsh; drug approval process

FDA Breakthrough Designations Lead to Priority Reviews, Report Finds

3 weeks ago talkbio0Tagged biotechnology innovation, Breakthrough Therapy, CDER, Drug Approval, expedited pathway, Identifier, Infrequent, Neoplasms, Priority Review, regulatory science, United States Food and Drug Administration

FDA; breakthrough therapy designation; priority review; drug approval; expedited pathway; biotechnology innovation; rare diseases; oncology; CDER; regulatory science

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

3 weeks ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

4 weeks ago talkbio0Tagged Center for Drug Evaluation, Center for Drug Evaluation and Research, Drug Approval, George Tidmarsh, leadership instability, OCE, Oncology Center of Excellence, Project, regulatory reform, research, review delays, Richard Pazdur, United States Food and Drug Administration

FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays

Can the CDER-CBER Dynamic Change Under New Leadership? Pazdur vs. Prasad in the FDA’s Turbulent 2025

4 weeks ago talkbio0Tagged agency instability, Biological Factors, CBER, CDER, Drug Approval, Leadership, Project, regulatory dynamics, Richard Pazdur, United States Food and Drug Administration, Vinay Prasad

Richard Pazdur; Vinay Prasad; FDA leadership; CDER; CBER; regulatory dynamics; drug approvals; biologics; agency instability; Project Orbis

Trump Announces Sweeping Cost Cuts on Lilly and Novo Weight Loss Drugs in Exchange for Medicare Coverage

1 month ago talkbio0Tagged drug price, Eli Lilly ; Novo Nordisk, Glucagon-Like Peptide 1, Medicaid, Medicare, Prices, Transplant Registry Unified Management Program, Wegovy, Weight-Loss Agents, Zepbound

Trump; Eli Lilly; Novo Nordisk; weight loss drugs; GLP-1; Medicare; Medicaid; Wegovy; Zepbound; price cuts; drug pricing deal

FDA Rejects Biohaven’s Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure

1 month ago talkbio0Tagged Ataxia, Spinocerebellar, Biohaven, Clinical Trial Design, Drug Approval, external controls, IL31RA gene, In complete remission, R&D, Rejection, Troriluzole, United States Food and Drug Administration, Vyglxia

Biohaven; FDA rejection; Vyglxia; troriluzole; spinocerebellar ataxia; CRL (Complete Response Letter); clinical trial design; external controls; drug approval; R&D cuts