Clinical Development – Page 2

Lexicon Pharmaceuticals Shifts Focus to Clinical Development Following Zynquista Setbacks

10 months ago talkbio0Tagged (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol, Clinical Development, lexicon, LX9211, LX9851, R&D pipeline, restructuring, United States Food and Drug Administration, Zynquista

Lexicon Pharmaceuticals, Zynquista, FDA, Clinical Development, Restructuring, R&D Pipeline, LX9211, Sotagliflozin, LX9851

Lexicon Pharmaceuticals Shifts Focus to Clinical Development Following FDA Setbacks

10 months ago talkbio0Tagged (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol, Chronic Kidney Diseases, Clinical Development, commercial, lexicon, restructuring, setbacks, Surgical aspects, United States Food and Drug Administration

Lexicon Pharmaceuticals, FDA setbacks, Clinical development focus, Commercial operations elimination, Sotagliflozin, Type 1 diabetes, Chronic kidney disease, Restructuring

Sensei Biotherapeutics Announces Major Restructuring: 46% Workforce Reduction and Closure of Rockville Research Site

10 months ago talkbio0Tagged Clinical Development, Organization administrative structures, Research Site Closure, restructuring, Sensei Biotherapeutics, SNS-101

Sensei Biotherapeutics, workforce reduction, research site closure, organizational restructuring, SNS-101 clinical development

Rapport Therapeutics Faces Regulatory Hurdles in Pain Treatment Trials

10 months ago talkbio0Tagged Clinical Development, RAP-219, Rapport Therapeutics, regulatory, treatment pain

Rapport Therapeutics, pain treatment trials, regulatory challenges, RAP-219, clinical development

Pfizer Terminates Development of Oral RSV Medication Sisunatovir Due to Ongoing Challenges

11 months ago talkbio0Tagged Acquisition (action), Clinical Development, Pfizer, Respiratory syncytial virus, ReViral, RSV, sisunatovir, Termination - Inactive Reason Code

Pfizer, ReViral, RSV, Sisunatovir, Acquisition, Clinical Development, Termination

GSK Advances mRNA Flu Vaccine to Late-Stage Clinical Development Following Positive Phase II Results

12 months ago talkbio0Tagged Clinical Development, Effectiveness, Late stage, RNA, Messenger, Safety, SmithKline Beecham, Vaccines

GSK, mRNA flu vaccine, phase II results, late-stage clinical development, influenza A and B strains, vaccine efficacy, safety profile.

Biogen and Sage Therapeutics Discontinue Development of SAGE-324 for Essential Tremor Following Mid-Stage Trial Failure

1 year ago talkbio0Tagged Biogen, Clinical Development, Essential Tremor, GABA Receptor Modulator, mid-stage trial, nervous system disorder, SAGE-324

Biogen, Sage Therapeutics, SAGE-324, Essential Tremor, Mid-Stage Trial, Neurological Disorder, GABA Receptor Modulator, Clinical Development

Ono Pharmaceutical Strengthens Oncology Portfolio with Acquisition of Deciphera Pharmaceuticals for $2.4 Billion

1 year ago talkbio0Tagged Acquisition (action), cancer treatments, Clinical Development, Collaboration, Deciphera, Dosage Forms, expansion, Generalized, Market, Oncology Pipeline, strategic

Ono Pharmaceutical, Deciphera Pharmaceuticals, oncology pipeline, acquisition, $2.4 billion, cancer treatments, kinase inhibitors, strategic expansion, global market, clinical development, collaboration.

Sanofi’s BTK Inhibitor Succeeds in Phase 3 LUNA Trial, Accelerating Regulatory Approval Race

1 year ago talkbio0Tagged BTK Inhibitor, Clinical Development, competition, Hematologic Neoplasms, LUNA, regulatory approval, sanofi

Sanofi, BTK inhibitor, LUNA trial, phase 3, regulatory approval, clinical development, blood cancer, competition

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

1 year 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