Multiple Acyl Coenzyme A Dehydrogenase Deficiency

CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz

1 week ago talkbio0Tagged Autoimmune thrombocytopenia, belumosudil, cGVHD, CHMP, chronic graft-versus-host disease, Clinical Data, Inosine Triphosphate, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, regulatory approval, Rezurock, Rilzabrutinib, sanofi, Wayrilz

Sanofi; CHMP; EMA; Rezurock; Wayrilz; Belumosudil; Rilzabrutinib; chronic graft-versus-host disease; cGVHD; immune thrombocytopenia; ITP; regulatory approval; clinical data

Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe

4 weeks ago talkbio0Tagged Biological Factors, Biosimilars, CDMO, Contract agreement, Digital innovation, Europe, Gdańsk, Guanosine Monophosphate, Manufacturing, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Rezon Bio, United States Food and Drug Administration, Warsaw-Duchnice

Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA

CHMP Recommends Against Approval of Elevidys Gene Therapy in Europe, Dealing Blow to Sarepta and Roche

3 months ago talkbio0Tagged CHMP, ELEVIDYS, EMBARK trial, Europe, gene therapy, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Muscular Dystrophy, Duchenne, negative opinion, Roche (company)

CHMP; Elevidys; Sarepta; Roche; gene therapy; Duchenne muscular dystrophy; EMA; negative opinion; Europe; EMBARK trial

CHMP Recommends Five New Drugs and Reviews Eli Lilly’s Kisunla

4 months ago talkbio0Tagged Biosimilars, CHMP, eli lilly, Hyperphosphatemia (disorder), Kisunla, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Myopia, regulatory review

CHMP; EMA; new drug approvals; Eli Lilly; Kisunla; biosimilars; hyperphosphatemia; myopia; March 2025; regulatory review

EMA Identifies Very Rare Eye Condition as Side Effect of Semaglutide

5 months ago talkbio0Tagged Adverse effects, Blindness, Infrequent, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, NAION, Ozempic, Rybelsus, semaglutide, Wegovy

EMA; semaglutide; rare side effect; NAION; vision loss; Ozempic; Wegovy; Rybelsus

EMA Reverses Decision, Recommends Approval of Lecanemab (Leqembi) for Early Alzheimer’s Disease in Specific Patient Group

11 months ago talkbio0Tagged 4, Alzheimer 's disease, amyloid-beta monoclonal antibody, Apolipoprotein E, CHMP, Lecanemab, Leqembi, Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Lecanemab, Leqembi, Alzheimer’s disease, EMA, CHMP, early Alzheimer’s disease, ApoE ε4, amyloid-beta monoclonal antibody

European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment

1 year ago talkbio0Tagged CHMP, Commission, Conditional, Decision, Drug Approval, European (ethnic group), Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Muscular Dystrophy, Duchenne, regulatory, Translarna

Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions

European Medicines Agency Investigates Potential Link Between Hair Loss Drugs and Suicidal Thoughts

1 year ago talkbio0Tagged Agencies, European (ethnic group), Feeling suicidal (finding), finasteride, Hair, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, psychiatric side effects

EMA, hair loss drugs, finasteride, dutasteride, suicidal thoughts, psychiatric side effects, European Medicines Agency

FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval

1 year ago talkbio0Tagged Boreas, Chronic Obstructive Airway Disease, Dupixent, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Notus, PDUFA, Phase 3 Clinical Trials, Priority Review, Regeneron, sanofi, United States Food and Drug Administration

FDA, Dupixent, COPD, EMA, Regeneron, Sanofi, Priority Review, PDUFA, Boreas, Notus, Phase III Trials

EMA Dispels Link Between GLP-1 Receptor Agonists and Suicidal Ideation Risk New

2 years ago talkbio0Tagged agonists, Continuous, Diabetes, Glucagon-Like Peptide-1 Receptor, Mental association, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, pharmacovigilance activities, Preventive monitoring, Suicidal ideation risk, Weight-Loss Agents

EMA, GLP-1 receptor agonists, Diabetes and weight-loss drugs, Suicidal ideation risk, No causal association, Pharmacovigilance activities, Continued monitoring