March 2024 – Page 2

AstraZeneca’s Ultomiris Gains FDA Approval for Rare Autoimmune Condition – NMOSD

1 year ago talkbio0Tagged Approved, AstraZeneca, Autoimmune Diseases, dosing, Infrequent, Long-acting C5 complement inhibitor, Neuromyelitis Optica, Rating (action), ravulizumab-cwvz, Reduced, Relapse, Ultomiris, United States Food and Drug Administration, With frequency

AstraZeneca, Ultomiris, ravulizumab-cwvz, FDA Approval, Rare Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD), Long-acting C5 complement inhibitor, Phase 3 CHAMPION-NMOSD Trial, Reduced Relapse Rate, Dosing Frequency

Alexion Expands Indications for Long-Acting C5 Complement Inhibitor Ultomiris in Rare Autoimmune Disorder NMOSD

1 year ago talkbio0Tagged Alexion, Annals, Approved, AstraZeneca Rare Disease, C5 complement inhibitor, CHAMPIER-NMOSD trial, generalised myasthenia gravis, gMG, long-acting, Marc Dunoyer, Neurology speciality, Neuromyelitis Optica, Paroxysmal nocturnal hemoglobinuria, Publications, ravulizumab-cwvz, Ultomiris, United States Food and Drug Administration

Ultomiris, ravulizumab-cwvz, C5 complement inhibitor, neuromyelitis optica spectrum disorder (NMOSD), FDA approval, long-acting, zero relapses, CHAMPIER-NMOSD trial, Annals of Neurology publication, Marc Dunoyer, AstraZeneca Rare Disease, Alexion, generalised myasthenia gravis (gMG), paroxysmal nocturnal haemoglobinuria (PNH).

FDA Grants Emergency Authorization for Invivyd’s Pemgarda Antibody Prophylactic Against COVID-19 in Immunocompromised Individuals

1 year ago talkbio0Tagged Adolescent (age group), Adults/, Approved, Condoms, Male, COVID19 (disease), Emergency Use Authorization, Half-Life Extended Monoclonal Antibody, immune compromise, Immunocompromised Host, Invivyd, Moderate (severity modifier), Pemgarda, pemivibart, Pre-Exposure Prophylaxis, Prophylactic treatment, Severe (severity modifier), United States Food and Drug Administration, VYD222

Invivyd, Pemgarda (pemivibart; formerly VYD222), Half-Life Extended Monoclonal Antibody, COVID-19 Prophylactic, Immunocompromised Patients, Emergency Use Authorization (EUA), FDA Approval, Moderate to Severe Immune Compromise, Pre-exposure Prophylaxis (Prevention) of COVID-19 in Adults/ Adolescents

Novo Nordisk Acquires Mid-Stage Heart Failure Biotech Cardior for Up to $1.1 Billion

1 year ago talkbio0Tagged Acquisition (action), biotech, Cardior, Heart failure, Nordisk

Novo Nordisk, Cardior Pharmaceuticals, Heart Failure Biotech, Acquisition, $1.1 billion

AbbVie Acquires Landos Biopharma to Enhance Post-Humira Immunology Pipeline

1 year ago talkbio0Tagged AbbVie, autoimmune startup, Humira, Immunology pipeline, Inflammatory Bowel Diseases, Landos Biopharma, Small acquisition

AbbVie, Landos Biopharma, Small acquisition, IBD (Inflammatory Bowel Disease) drug, Humira, Autoimmune startup, Immunology pipeline

Roche’s Phase III Trial Success with IL-6 Blocker Enspryng Tempered by Modest Outcomes

1 year ago talkbio0Tagged Blocker, disappointment, Enspryng, Expectations, interleukin-6, Myasthenia Gravis, Generalized, Phase 3 Clinical Trials, Roche (company), satralizumab

Roche, IL-6 blocker, Enspryng (satralizumab), Phase III trial, Generalized Myasthenia Gravis (gMG), Disappointment, Expectations

EU Approves Novo Nordisk’s Groundbreaking Once-Weekly Basal Insulin Icodec for Adults with Diabetes

1 year ago talkbio0Tagged Awiqli, CHMP, European Medicines Agency, insulin icodec, Nordisk, Once-Weekly Insulin Shot

Novo Nordisk, Once-Weekly Insulin Shot, Awiqli, Insulin Icodec, European Medicines Agency (EMA), CHMP Positive Opinion, Type 1 & Type 2 Diabetes Treatment