Governmental or Regulatory Activity

FDA Staffing Data Reveal Historic Departures in Fiscal 2025

4 days ago talkbio0Tagged CBER, CDER, departures, Disruption, Drug Approval, fiscal, layoffs, Organization administrative structures, Regulatory Impact, United States Food and Drug Administration, Workforce - population group

FDA; staffing; departures; fiscal 2025; layoffs; regulatory impact; CDER; CBER; drug approval delays; organizational disruption

Rethinking Strategies in Pharma Amidst Supply Chain Disruptions

5 days ago talkbio0Tagged Capability, Cost Control, Pharma, supply chain

pharma; supply chain; cost control; capability building

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

1 week 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

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

1 week 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

Boehringer Ingelheim Strikes Nearly $1B ADC Deal with AimedBio; EyePoint Pharmaceuticals Announces $150M Stock Sale

1 week ago talkbio0Tagged AimedBio, Antibody-Drug Conjugates, Biopharma, Boehringer Ingelheim, Cancer Therapeutic Procedure, EyePoint, Funding, Licensing, stock sale, therapeutic autologous dendritic cells

Boehringer Ingelheim; AimedBio; antibody-drug conjugate; ADC; cancer therapy; biotech licensing deal; EyePoint Pharmaceuticals; stock sale; biopharma funding

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

2 weeks 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 weeks 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 weeks 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 weeks 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 weeks 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