Temporal Concept – Page 5

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

2 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

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

2 months ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

AstraZeneca Amyloidosis Drug Fails Phase 3 Trials but Shows Potential in Subgroup

2 months ago talkbio0Tagged Alexion, Amyloidosis, Anselamimab, AstraZeneca, Clinical trial failure, Drug Development, Infrequent, prespecified, Primary amyloidosis, Subgroup A Nepoviruses

AstraZeneca; amyloidosis; anselamimab; Phase 3 trial; clinical trial failure; prespecified subgroup; rare diseases; Alexion; AL amyloidosis; drug development

Recent Developments in Building Measurable Patient Support Programs (2025)

2 months ago talkbio0Tagged 2025, care activity, collaborative healthcare, Efficiency, Financial cost, measurable outcomes, Medicare reforms, Programs - Publication Format, trends qualifier

patient support programs; measurable outcomes; collaborative healthcare; 2025 trends; Medicare reforms; cost efficiency; access to care

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

2 months ago talkbio0Tagged Capricor Therapeutics, Cardiomyopathies, Cell Therapy, Clinical Data, Complete, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3, Rejection, Response process, United States Food and Drug Administration

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

Biopharma Layoffs Continue to Surge in First Half of 2025

2 months ago talkbio0Tagged Biopharma, biotech closures, Increase, Industry, layoffs, trends qualifier

biopharma; layoffs; 2025; workforce reductions; industry trends; biotech closures; year-over-year increase

AbbVie Acquires Rights to Ichnos Glenmark’s Lead Myeloma Antibody (ISB 2001) in $1.93 Billion Deal

2 months ago talkbio0Tagged AbbVie, bis(3-bis(4-chlorophenyl)methyl-4-dimethylaminophenyl)amine, CD3 Antigens, CD38 Antigen, Clinical Trials, Global Licensing, Ichnos Glenmark, ISB, Multiple Myeloma, Neoplasms, Phase 1 (qualifier value), Trispecific Antibody

AbbVie; Ichnos Glenmark; ISB 2001; trispecific antibody; multiple myeloma; biotech deal; CD3; BCMA; CD38; Phase 1 clinical trial; global licensing; oncology

AstraZeneca’s Alexion Signs $825M AAV Capsid Deal with JCR Pharma

2 months ago talkbio0Tagged AAVS1 gene, Alexion, AstraZeneca, Capsid, gene therapy, genomic medicines, Infrequent, JCR, JUST-AAV, Licensing Deal

AstraZeneca; Alexion; JCR Pharmaceuticals; JUST-AAV; gene therapy; AAV capsid; rare disease; licensing deal; genomic medicines

Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

3 months ago talkbio0Tagged ARROS-1 trial, Frequency of Responses, Metastatic malignant neoplasm to brain, Neoplasms, Non-Small Cell Lung Carcinoma, Nuvalent, Protein-tyrosine kinase inhibitor, ROS1-positive Lung Cancer, Submission, United States Food and Drug Administration, zidesamtinib

Nuvalent; ROS1-positive lung cancer; zidesamtinib; FDA submission; ARROS-1 trial; NSCLC; tyrosine kinase inhibitor; objective response rate; brain metastases; oncology

Amgen Adjusts Phase 3 Dosing for MariTide After Midstage Side Effects Concerns

3 months ago talkbio0Tagged Adverse event, amgen, Clinical Trials, Dosage, Escalation, gastric inhibitory polypeptide receptor, GLP-1 receptor, MariTide, Obesity, Phase 3, Vomiting

Amgen; MariTide; Phase 3; obesity treatment; dose escalation; vomiting; adverse events; clinical trial; GLP-1 receptor; GIP receptor