Finding – Page 22

Verve Temporarily Halts Lead Base Editing Study Following Adverse Event, Prioritizes Alternative Therapy

1 year ago talkbio0Tagged Adverse event, Alanine Transaminase, Alternative Therapies, Cognitive function: initiation, Elevation procedure, Grade three rank, Heart-1 study, Heart-2 clinical trial, Ionizable, Lead base editing program, lipid delivery system, Pause enrollment, Phase Ib Heart-2 clinical trial, Q2 2024, SAEs, Serious adverse events, Thrombocytopenia, VERVE-101, VERVE-102

Verve Therapeutics, Lead base editing program, Adverse event, VERVE-101, Serious adverse events (SAEs), Grade 3 ALT elevation, Thrombocytopenia, Pause enrollment in Heart-1 study, Alternative therapy focus: VERVE-102, Ionizable lipid delivery system, Phase Ib Heart-2 clinical trial, Q2 2024 initiation of Heart-2 clinical trial.

Pfizer Continues FDA Approval Expectations for Sickle Cell Disease Therapy Despite Terminating One Phase 3 Trial

1 year ago talkbio0Tagged Antibody/, Approval/, Disease/, Inclacumab/, monoclonal, Pfizer/, Program/, terminated - RoleStatus, Thrive, Trial/ Poor Accrual, United States Food and Drug Administration

Pfizer/ Sickle Cell Disease/ FDA Approval/ Inclacumab/ THRIVE Program/ Monoclonal Antibody/ Terminated Trial/ Poor Accrual

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

Axsome Therapeutics’ Small Molecule AXS-12 Successful in Phase III Narcolepsy Trial

1 year ago talkbio0Tagged AXS-12, Axsome, Cataplexy, Drowsiness, Improved, memory/, Narcolepsy, Phase 3 Clinical Trials, reboxetine, safety profile, Severities

Axsome Therapeutics, AXS-12 (reboxetine), Phase III trial, Narcolepsy, Cataplexy reduction, Improved cognition/ memory/ sleepiness severity, Safety profile

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

“Continuum Biologics’ PIPE-791 Advances with Johnson & Johnson Partnership in Initial Public Offering (IPO)”

1 year ago talkbio0Tagged Biological Factors, Continuum, Demyelinating Diseases, IPO, Johnson & Johnson, LPAR1 antagonist, LPAR1 gene, Multiple Sclerosis, Neuroinflammation, PIPE-791, Public Offering, Receptors, Lysophosphatidic Acid

Continuum Biologics, PIPE-791, Johnson & Johnson partnership, Initial Public Offering (IPO), Multiple sclerosis, Demyelinating diseases, Neuroinflammation, LPAR1 antagonist, Lysophosphatidic acid receptor Edg-2 antagonist

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.

J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations

1 year ago talkbio0Tagged amivantamab-vmjw, Approved, carboplatin-pemetrexed chemotherapy, Disease Progression, EGFR Exon 20, first-line, Insertion Mutation, Johnson and Johnson, Mortality Risk, Non-Small Cell Lung Carcinoma, Objective Response Rate, ORR, Progression-Free Survival, Reduced, Rybrevant, United States Food and Drug Administration

Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)