2025 – Talk Bio

AstraZeneca’s Self-Administered Myasthenia Gravis Drug Gefurulimab Clears Phase 3 Trial

9 hours ago talkbio0Tagged Acquisition, Alexion, AstraZeneca, Autoimmune Diseases, C5 inhibitor, Clinical Trials, Gefurulimab, Myasthenia Gravis, PREVAIL trial, self-administered drug

AstraZeneca; gefurulimab; myasthenia gravis; self-administered drug; Phase 3 trial; PREVAIL trial; C5 inhibitor; autoimmune disease; clinical trial; Alexion acquisition

RFK Jr. Approves ACIP Recommendation to Remove Thimerosal from U.S. Flu Vaccines

11 hours ago talkbio0Tagged ACIP, RFK Jr., thimerosal, Vaccine Safety

RFK Jr.; Thimerosal; ACIP; Vaccine Safety

LEO Pharma Scores FDA Approval for Anzupgo as First Treatment for Chronic Hand Eczema

11 hours ago talkbio0Tagged Anzupgo, Approved, Chechen language, chronic hand eczema, delgocitinib, pan-JAK inhibitor, Pharma, topical treatment, United States Food and Drug Administration

LEO Pharma; Anzupgo; delgocitinib; FDA approval; chronic hand eczema; pan-JAK inhibitor; moderate-to-severe CHE; topical treatment

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

11 hours 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

Flagship’s Most-Funded Startups, Generate and Tessera, Announce Layoffs in 2025

12 hours ago talkbio0Tagged Biomedicines, Flagship, layoffs, Pioneering, startups, Tessera

Flagship Pioneering; startups; Generate:Biomedicines; Tessera; layoffs; biotech; 2025

Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug

18 hours ago talkbio0Tagged AD109, Apnimed, aroxybutynin, atomoxetine, Clinical Trials, LunAIRo, oral drug, Sleep Apnea, Obstructive, Submission, SynAIRgy, United States Food and Drug Administration

Apnimed; AD109; obstructive sleep apnea; OSA; oral drug; phase 3 trial; LunAIRo; SynAIRgy; FDA submission; clinical trial; aroxybutynin; atomoxetine

Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns

1 day ago talkbio0Tagged concerns, ELEVIDYS, gene therapy, halt, Muscular Dystrophy, Duchenne, patient deaths, Roche (company), Safety, shipment, United States Food and Drug Administration

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

Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure

1 day ago talkbio0Tagged concerns, DMD, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Safety, shipment, Suspensions, United States Food and Drug Administration

Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy (DMD); FDA; gene therapy; safety concerns; shipment suspension; patient deaths

CDMO Pulse Check: Lonza Posts Major Sales Rebound as Samsung Bio Keeps Revenue Growth Rolling

1 day ago talkbio0Tagged capsule (pharmacologic), CDMO, commercial, expansion, Growth, Lonza, Manufacturing, profit margin, Sales - occupational activity, Samsung Bio

Lonza; CDMO; sales growth; Samsung Bio; 2025 outlook; profit margin; Capsules & Health Ingredients; commercial momentum; manufacturing expansion

CorestemChemon Partners with ATG Lifetech to Expand Organoid and Transcriptomics Capabilities

1 day ago talkbio0Tagged Blood - brain barrier anatomy, CorestemChemon, Drug Discovery, FDA/EMA regulatory pathways, Gene Expression Profiling, heart organoids, Lifetech, liver organoids, lymphocyte immune globulin, anti-thymocyte globulin, Organoids, preclinical CRO, Predictive analytics, Tumorigenicity

CorestemChemon; ATG Lifetech; organoids; transcriptomics; preclinical CRO; drug discovery; predictive analytics; tumorigenicity; FDA/EMA regulatory pathways; liver organoids; heart organoids; blood-brain barrier models