Therapeutic or Preventive Procedure – Page 95

Acorda Therapeutics Concludes $185M Asset Sale with Merz amid Bankruptcy Filing Following Disappointing Sales

1 year ago talkbio0Tagged Acorda, asset, Bankruptcy filing, Biogen returns, Declining sales, ex-US, Fampyra, Generic competition, Merz, Multiple Sclerosis drug, Neurological diseases, year

Acorda Therapeutics, $185M asset sale, Merz, Bankruptcy filing, Years of disappointing sales, Multiple Sclerosis drug Fampyra, Biogen returns ex-US rights, Generic competition, Declining sales, Neurological diseases

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.

Carisma Therapeutics to Lay Off Staff, Discontinue CAR-M Programs in Pursuit of Second Candidate

1 year ago talkbio0Tagged 37%, anti-HER2, Anti-mesothelin, Autologous Anti-HER2 CAR Macrophages CT-0508, CAR-macrophage, CAR-monocyte, Carisma, clinical CAR-M program, CT-1119, Dropping, layoffs, second, Workforce reduction

Carisma Therapeutics, Layoffs, Workforce reduction (37%), Dropping clinical CAR-M program, Anti-HER2 CAR-macrophage CT-0508, Anti-mesothelin CAR-monocyte candidate CT-1119, Second candidate focus

FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults

1 year ago talkbio0Tagged Anemia, Approved, Black Box Warning, Chronic Kidney Diseases, Daprodustat, Effectiveness, Hemoglobin concentration result, Jesduvroq, Oral Medication, post-marketing safety, Safety, United States Food and Drug Administration, vadadustat, Vafseo

Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data

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

Groundbreaking Data Revealed for Genetic Epilepsy Drug STK-001 by Stoke Therapeutics, Exhilarating Investors

1 year ago talkbio0Tagged Antisense Oligonucleotides, Genetic Epilepsy Drug, Infantile Severe Myoclonic Epilepsy, investor, Level of interest, Positive Clinical Trial, Seizures, STK-001, Stoke

Stoke Therapeutics, STK-001, Genetic Epilepsy Drug, Dravet Syndrome, Antisense Oligonucleotide, Seizure Reduction, Positive Clinical Trial Data, Investor Enthusiasm

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

Orchard Therapeutics Sets $4.25 Million Price Tag for Leukodystrophy Gene Therapy

1 year ago talkbio0Tagged Grail, Lenmeldy, Leukodystropy, Orchard, Prices

Orchard Therapeutics, Leukodystropy, Gene Therapy, Lenmeldy, $4.25 million US price tag

FDA Greenlights Idorsia’s Aprocitentan (Tryvio) for Resistant Hypertension Patients

1 year ago talkbio0Tagged 12.5 mg, Approved, aprocitentan, aspects of adverse effects, Availability of, Clinical Trials, Combined Modality Therapy, Edema, Endothelin receptor antagonist, Idorsia, Intravascular systolic:Pressure:Point in time:Arterial system:Quantitative, Liquid substance, Precision - temporal, Recommended dosage, Resistant hypertensive disorder, Retention (Psychology), Second Half of 2024, Tryvio, Uncontrolled hypertension, United States Food and Drug Administration

FDA approval, Idorsia, Aprocitentan, Tryvio, Resistant hypertension, Endothelin receptor antagonist, Systolic blood pressure, Uncontrolled hypertension, Combination therapy, Clinical trials, PRECISION study, Recommended dosage: 12.5 mg, Availability: Second half of 2024, Edema and fluid retention side effects