Qualitative Concept – Page 43

SIGA’s TPOXX Fails to Demonstrate Efficacy in Treating Mild to Moderate Mpox Cases: STOMP Study Results

9 months ago talkbio0Tagged 3-(2-methoxyphenyl)-5-methoxy-1,3,4-oxadiazol-2(3H)-one, antiviral treatment, Clinical Research, Effectiveness, Safety, Secretory Immunoglobulin A, STOMP, Technology, tecovirimat, Tpoxx

SIGA Technologies, TPOXX, Tecovirimat, Mpox, STOMP Study, Antiviral Treatment, Efficacy, Safety Profile

Candel Therapeutics Sees Dramatic Stock Surge Following Successful Phase III Prostate Cancer Trial

9 months ago talkbio0Tagged Approved, CAN-2409, Candel, Malignant neoplasm of prostate, Phase 3 Clinical Trials, surge, United States Food and Drug Administration, viral immunotherapy

Candel Therapeutics, CAN-2409, Phase III trial, prostate cancer, viral immunotherapy, stock surge, FDA approval

uniQure Secures FDA Agreement on Accelerated Approval Pathway for Huntington’s Disease Gene Therapy AMT-130

9 months ago talkbio0Tagged Accelerated, AMT-130, Approved, cUHDRS, gene therapy, Huntington 's disease, NEFL gene, NfL, Regenerative Medicine, RMAT, UniQure, United States Food and Drug Administration

uniQure, FDA, Accelerated Approval, Huntington’s Disease, Gene Therapy, AMT-130, cUHDRS, Neurofilament Light Chain (NfL), Regenerative Medicine Advanced Therapy (RMAT)

Advancements in BTK Inhibitors for Chronic Lymphocytic Leukemia: A Comparative Analysis of AstraZeneca, Eli Lilly, and BeiGene Therapies

9 months ago talkbio0Tagged acalabrutinib, AstraZeneca, BeiGene, Bruton's Tyrosine Kinase Inhibitors [MoA], Chronic Lymphocytic Leukemia, CLL, Continuous therapy, Effectiveness, Eli, Eli Lilly, Fixed-Duration Therapy, ibrutinib, Nemtabrutinib, Pirtobrutinib, Safety, zanubrutinib

BTK inhibitors, Chronic Lymphocytic Leukemia (CLL), AstraZeneca, Eli Lilly, BeiGene, Acalabrutinib, Ibrutinib, Zanubrutinib, Pirtobrutinib, Nemtabrutinib, Fixed-duration therapy, Continuous therapy, Efficacy, Safety

Strategic Roadmap for Biologics Manufacturing: Enhancing Efficiency and Flexibility

9 months ago talkbio0Tagged Biological Factors, biomanufacturing, bony process, Characterization, Continuous, Efficiency, Manufacturing, Modular Facilities, Pliability, Precision medicines, Regulatory Compliance, Strategic Roadmap, technology roadmap

Biologics manufacturing, Strategic roadmap, Process characterization, Flexibility and efficiency, Regulatory compliance, Biomanufacturing technology roadmap, Precision medicines, Modular facilities, Continuous manufacturing

Novo Holdings Receives Unconditional EU Approval for $16.5 Billion Acquisition of Catalent

9 months ago talkbio0Tagged Acquisition, Approved, Catalent, Commission, EU, European (ethnic group), Holdings, Pharmaceutical Services

Novo Holdings, Catalent, European Commission, Acquisition, EU Approval, Pharmaceutical Services

Novartis Reveals Sustained Efficacy and Safety of Fabhalta in Patients Switching from Anti-C5 Therapies for Paroxysmal Nocturnal Hemoglobinuria (PNH)

9 months ago talkbio0Tagged anti-C5, Avoidance, Blood Transfusion, Effectiveness, Fabhalta, Hemoglobin improvement, Iptacopan, Paroxysmal, Paroxysmal nocturnal hemoglobinuria, PNH, Safety, Switching therapies

Fabhalta (iptacopan), Paroxysmal Nocturnal Hemoglobinuria (PNH), Anti-C5 therapies, Efficacy and safety, Switching therapies, Hemoglobin improvement, Transfusion avoidance

FDA Grants Accelerated Approval to Merus’ Bizengri for NRG1+ Lung and Pancreatic Cancers

9 months ago talkbio0Tagged Accelerated, Approved, Bizengri, Malignant neoplasm of lung, Malignant Neoplasms, Merus, N.V., NRG1 gene, Pancreatic carcinoma, United States Food and Drug Administration, zenocutuzumab-zbco

Bizengri, NRG1+ cancers, FDA accelerated approval, lung cancer, pancreatic cancer, zenocutuzumab-zbco, Merus N.V.

FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC

9 months ago talkbio0Tagged ADRIATIC, Approved, Breakthrough Therapy, durvalumab, Identifier, Imfinzi, Limited-stage, LS-SCLC, Phase 3 Clinical Trials, Priority Review, Systemic Immunotherapy, United States Food and Drug Administration

Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review

Novo Nordisk Invests $409M in New Quality Control Lab in Denmark

9 months ago talkbio0Tagged Biotechnology, Denmark, Dosage Forms, Nordisk, Quality

Novo Nordisk, quality control lab, Denmark, pharmaceutical investment, biotechnology