Qualitative Concept – Page 61

AstraZeneca and Daiichi Sankyo’s Enhertu Wins Historic FDA Approval as First Tumor-Agnostic HER2-Directed Therapy

1 year ago talkbio0Tagged Accelerated Approval, Approved, AstraZeneca, Daiichi Sankyo, DESTINY-PanTumor02 Study, Enhertu, HER2-directed therapy, Metastatic HER2-Positive Solid Tumors, Objective Response Rate, ORR, Response Duration, tumor-agnostic, United States Food and Drug Administration

Enhertu, AstraZeneca, Daiichi Sankyo, FDA Approval, Tumor-Agnostic, HER2-Directed Therapy, Metastatic HER2-Positive Solid Tumors, Accelerated Approval, DESTINY-PanTumor02 Study, Objective Response Rate (ORR), Duration of Response (DoR)

Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections

1 year ago talkbio0Tagged ABSSSI, Acute bacterial skin, Approved, Bacteremia due to Staphylococcus aureus, Basilea Pharmaceutica, CABP, ceftobiprole, Community-acquired bacterial pneumonia, designations, exclusivity, Priority Review, QIDP, Qualified Infectious Disease Product, skin structure infections, Track/, United States Food and Drug Administration, year, Zevtera

Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

1 year ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024

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

Gilead Partners with Xilio Therapeutics for Novel Tumor-Activated IL-12 Program

1 year ago talkbio0Tagged development aspects, interleukin-12, Xilio, XTX301

interleukin-12, Xilio, XTX301, development aspects

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

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

Medicare Partially Covers Weight Loss Drugs Amidst High Price Concerns and Future Negotiation Prospects

1 year ago talkbio0Tagged accessibility, Administration occupational activities, Affordability, Increased, Mediation, Medicare, Obesity drugs, premium, Prices, semaglutide, utilization qualifier, Wegovy

Medicare, Obesity drugs, Wegovy, Semaglutide, Price negotiation, Affordability, Accessibility, Premium increases, Utilization management