Immunologic Factor – Page 47

Pfizer Discontinues Phase III Trial for Sickle Cell Treatment Amid Challenges in Patient Recruitment

1 year ago talkbio0Tagged Anemia, Sickle Cell, ClinicalTrials.gov, Grail, inclacumab, Pfizer, Phase 3 Clinical Trials, Poor Accrual, Recruitment Challenges, THRIVE Program

Pfizer, Sickle Cell Disease, Phase III Study, Inclacumab, Poor Accrual, Recruitment Challenges, THRIVE Program, ClinicalTrials.gov, Gene Therapies

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).

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

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

1 year ago talkbio0Tagged Accelerated Approval, Aduhelm, Anticipated, Approved, aspects of adverse effects, Central Nervous System Agents, Cerebral Edema, Clinical Trials, Deferred, Donanemab, Effectiveness, eli lilly, Full approval, Hemorrhage, Leqembi, PCNS, Peripheral, precedent, Review [Publication Type], Safety, United States Food and Drug Administration

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.

MacroGenics and AbbVie Discontinue Development of ADAM9 Antibody-Drug Conjugate (IMGC936)

1 year ago talkbio0Tagged AbbVie, ADAM9 protein, human, Anti-ADAM9 ADC IMGC936, Effectiveness, issues, MacroGenics, Partnered ADC, Safety Concerns

MacroGenics, AbbVie, Partnered ADC, ADAM9, IMGC936, Early Data, Safety Concerns, Efficacy Issues

Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks

1 year ago talkbio0Tagged Accelerated, Antibodies, Bispecific, Approved, BeiGene, Brukinsa, Chimeric Antigen Receptor T-cells, Clinical Trials, Combined Modality Therapy, competition, Disease Progression, Gazyva, Lymphoma, Follicular, obinutuzumab, ORR, Overall response rate, Rosewood, Toxicity aspects, United States Food and Drug Administration, zanubrutinib

Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies