Qualitative Concept – Page 71

Intra-Cellular’s Caplyta Shows Promising Results in Major Depressive Disorder Study

1 year ago talkbio0Tagged adjunctive therapy, blockbuster label, Caplyta, Clinical Global Impression Original Version Questionnaire, expansion, Intra-Cellular Therapies, Lumateperone, Major Depressive Disorder, MDD, Montgomery-Åsberg depression rating scale, Montgomery-Asberg Depression Rating Scale Questionnaire, Positive Clinical Trial, Study 501, Unipolar Depression

Intra-Cellular Therapies, Caplyta (lumateperone), Major Depressive Disorder (MDD), Positive clinical trial results, Study 501, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale, Adjunctive therapy, Potential blockbuster label expansion

Neumora Therapeutics’ Schizophrenia Drug NMRA-266 Faces FDA Hold Over Convulsions in Rabbits

1 year ago talkbio0Tagged Neumora, NMRA-266, Schizophrenia, Seizures, United States Food and Drug Administration

Neumora, United States Food and Drug Administration, NMRA-266, Seizures, Schizophrenia

EU Approves Illumina’s Divestment Plan for Cancer Test Maker Grail

1 year ago talkbio0Tagged cancer diagnostic subsidiary, Capitalization, Clearance, Divestment, EU, European Commission, Illumina

Illumina, Grail, EU clearance, Divestment, European Commission, Cancer diagnostic subsidiary, Capitalization terms

AstraZeneca’s FASENRA Gains FDA Approval for Add-On Maintenance Treatment of Severe Asthma in Children Aged 6-11

1 year ago talkbio0Tagged Age, Approved, AstraZeneca, benralizumab, Child, expansion, Fasenra, Pediatric Label, Severe asthma, United States Food and Drug Administration

AstraZeneca, FASENRA, Benralizumab, Severe Asthma, Pediatric Label Expansion, FDA Approval, Children Aged 6-11

US Drug Shortages Hit Record High Since 2001: ASHP Report

1 year ago talkbio0Tagged ASHP, Attention deficit hyperactivity disorder, Biden administration, Central Nervous System Stimulants, Chemotherapy Drugs Adminstered, controlled substance, Defense Production Act, DPA, Drug Enforcement Administration, Drug shortages, hormone agents, Hospitals, Incentives, intravenous fluids, Microbicides, Quality concerns, Record high, American Society of Health-System Pharmacists, shortage, Supply Chain Resilience, White House Council

Drug shortages, Record high, American Society of Health-System Pharmacists (ASHP), 323 drugs in shortage, Chemotherapy drugs, ADHD therapies, Central nervous system stimulants, Antimicrobials, Hormone agents, Intravenous fluids, Drug Enforcement Administration (DEA), Biden administration, White House Council on Supply Chain Resilience, Defense Production Act (DPA), Incentives for hospitals, Quality concerns, Controlled substances

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