Governmental or Regulatory Activity – Page 2

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

Recent News: Live at 11 a.m. ET – M&A, FDA, MFN and Collaboration with FT

1 month ago talkbio0Tagged Acquisitions, Drug Approval, Economics, Financial Times, Live - Specimen Condition, M&A, mergers, MFN, News [Publication Type], United States Food and Drug Administration

M&A; FDA; MFN; Financial Times; mergers and acquisitions; drug approval; economics; live news

‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil

1 month ago talkbio0Tagged agency turmoil, Center for Drug Evaluation, Center for Drug Evaluation and Research, George Tidmarsh, Kevin Tang, Leadership, personal conduct probe, Regulatory Authority, research, resignation, United States Food and Drug Administration

FDA; George Tidmarsh; resignation; personal conduct probe; Kevin Tang; Center for Drug Evaluation and Research (CDER); agency turmoil; Vinay Prasad; leadership transitions; regulatory authority

Step Pharma Appoints Dr. Karen L. Smith as Chief Medical Officer

2 months ago talkbio0Tagged Biological Factors, Chief Medical Officer, Clinical Development, CTPS1 inhibitor, dencatistat, Karen Smith, Neoplasms, Regulatory Affairs, Step Pharma

Step Pharma; Karen Smith; Chief Medical Officer; CTPS1 inhibitor; dencatistat; oncology; clinical development; biopharmaceutical; regulatory affairs

GSK Secures Exclusive Rights to Syndivia’s Preclinical Prostate Cancer ADC in $357 Million Deal

2 months ago talkbio0Tagged asset, GeminiMab technology, Licensing, Malignant neoplasm of prostate, Metastatic castration-resistant prostate cancer, milestone payments, Oncology Pipeline, Preclinical, SmithKline Beecham, Syndivia, therapeutic autologous dendritic cells

GSK; Syndivia; ADC; prostate cancer; metastatic castration-resistant prostate cancer; exclusive licensing; oncology pipeline; GeminiMab technology; milestone payments; preclinical asset

FDA Staffing Data Reveal Historic Departures in Fiscal 2025

2 months 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

2 months 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

2 months 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

2 months 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

2 months 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