Temporal Concept – Talk Bio

FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys

1 day ago talkbio0Tagged approval status, CBER, concerns, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, Pauses, Safety, Scientific Study, shipment, United States Food and Drug Administration

Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status

FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans

2 days ago talkbio0Tagged Blenrep, Deferred, Multiple Myeloma, Neoplasms, Ocular Toxicity, PDUFA, regulatory hurdles, SmithKline Beecham, United States Food and Drug Administration

FDA delay; Blenrep; GSK; multiple myeloma; regulatory hurdles; ocular toxicity; PDUFA; oncology; relapsed/refractory

Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys

4 days ago talkbio0Tagged ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Pauses, Safety, shipment, United States Food and Drug Administration

Sarepta Therapeutics; FDA; Elevidys; Duchenne muscular dystrophy; gene therapy; shipment pause; patient deaths; safety concerns

Replimune’s Shares Plunge After FDA Rejects Melanoma Drug Application

4 days 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

1 week 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

1 week 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 weeks 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 weeks 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 weeks 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 weeks 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