Clinical Trial Design

FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

2 weeks ago talkbio0Tagged Circadian Rhythms, Clinical Trial Design, collaborative framework agreement, decision letter, expansion, Hetlioz, jet lag disorder, Labels (device), NDA, phase advance protocol, Rejection, Sleep Disorders, Supplement, tasimelteon, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; tasimelteon; jet lag disorder; FDA rejection; supplemental NDA; decision letter; phase advance protocol; circadian rhythm; clinical trial design; collaborative framework agreement; D.C. Circuit ruling; label expansion; sleep disorder drug; regulatory dispute

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

3 months 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

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

6 months ago talkbio0Tagged Antineoplastic Agents, Clinical Trial Design, Complete, Drops - Drug Form, Frequency of Responses, melanoma, Prices, Rejection, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration

Replimune; RP1; FDA rejection; melanoma; cancer drug; Complete Response Letter; clinical trial design; objective response rate; share price drop

Oncology Market in 2025: Innovation, Growth, and Patient-Centric Care

11 months ago talkbio0Tagged Artificial Intelligence, Biosimilars, Clinical Trial Design, Combined, Immunotherapy for cancer, Neoplasms, Personalized cancer care, Precision Medicine, targeted therapies

Cancer immunotherapy, Targeted therapies , Precision medicine, AI in oncology, Combination treatments, Biosimilars, Clinical trial design, Personalized cancer care

Pragmatic Clinical Trials: Bridging the Gap Between Research and Real-World Practice

1 year ago talkbio0Tagged Clinical Trial Design, Effectiveness, Evidence, Healthcare decision making, Pragmatic Clinical Trials as Topic, Real-world, research

1. Pragmatic Clinical Trials, 2. Real-World Evidence, 3. Clinical Trial Design, 4. Effectiveness Research, 5. Healthcare Decision Making

Director/Vice President of Translational Research: Leading the Bridge from Discovery to Clinical Development

2 years ago talkbio0Tagged approvals, Biological Assay, Biological Markers, Biomarker Strategy, Clinical Development, Clinical Trial Design, Cross-Functional Collaboration, development aspects, Discover, Drug Molecule Development, End Point, Leadership, PK/ PD/, Preclinical Development, regulatory, Target, Team Building, Translational Research, Biomedical, Translational Science Leadership

Translational Research, Biomarker Discovery, Preclinical Development, Early Clinical Development, Drug Molecule Development, Translational Science Leadership, Biomarker Development, Target Engagement Strategies, Assay Development (PK/ PD/ Immunogenicity), Clinical Trial Design, Endpoint and Biomarker Strategy, Team Building and Leadership, Cross-Functional Collaboration, Regulatory Approvals