Temporal Concept – Page 30

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)

AstraZeneca’s Lynparza Demonstrates Nearly 50% Response in Advanced Breast Cancer Patients: #AACR24 Update

1 year ago talkbio0Tagged 50, AACR24, advanced breast cancer, AstraZeneca, Frequency of Responses, Inhibitor, Lynparza, olaparib, PARP1 gene

AstraZeneca, Lynparza (olaparib), PARP inhibitor, Advanced breast cancer, 50% response rate, AACR24

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

Vanda’s Fanapt Secures Second FDA Approval for Treating Bipolar I Disorder

1 year ago talkbio0Tagged acute, Bipolar I disorder, Dentatorubral-Pallidoluysian Atrophy, Fanapt, iloperidone, Manic, mixed episodes, United States Food and Drug Administration, Vanda Pharmaceuticals

Fanapt, Vanda Pharmaceuticals, Bipolar I Disorder, Second FDA Nod, Iloperidone, Acute Treatment of Manic or Mixed Episodes

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

Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges

1 year ago talkbio0Tagged Bankruptcy, Biological Factors, Chapter 11, Assets Sale, development aspects, Eiger, Infrequent, Metabolic Disease Therapy, Operational Wind Down

Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development

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

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