Vertex Receives the US FDA’s IND Clearance of VX-264 for the Treatment of Type 1 Diabetes

Date: Mar 10, 2023 | Tags: Vertex, VX-264, Type 1 Diabetes, Regulatory, US, FDA, IND

Alnylam Expands its Collaboration with Medison Pharma to Commercialize RNAi Therapies

Date: Mar 10, 2023 | Tags: Alnylam, Medison Pharma, RNAi Therapies, Onpattro, patisiran, Givlaari, givosiran, Oxlumo, lumasiran, Biotech

BerGenBio Reports the First Patient Dosing of Bemcentinib in the P-Ib/IIa Trial as 1L Treatment of Non-Small Cell Lung Cancer

Date: Mar 10, 2023 | Tags: BerGenBio, Bemcentinib, Non-Small Cell Lung Cancer, Clinical Trial, P-Ib/IIa Trial  

AstraZeneca Reports P-III Trial (AEGEAN) Results of Imfinzi (durvalumab) for Non-Small Cell Lung Cancer

Date: Mar 10, 2023 | Tags: AstraZeneca, Imfinzi, durvalumab, Non-Small Cell Lung Cancer, Clinical Trial, P-III, AEGEAN Trial 

Astellas and Seagen Report the NMPA’s Acceptance of BLA for Enfortumab Vedotin to Treat Urothelial Cancer

Date: Mar 10, 2023 | Tags: Astellas, Seagen, Enfortumab Vedotin, Urothelial Cancer, Regulatory, NMPA, BLA 

AstraZeneca Reports P-III Trial (ADAURA) Results of Tagrisso (osimertinib) for Adjuvant Treatment of Early-Stage EGFR-Mutated Lung Cancer

Date: Mar 10, 2023 | Tags: AstraZeneca, Tagrisso, Osimertinib, Lung Cancer, Clinical Trial, P-III, ADAURA Trial 

Eli Lilly Reports the US FDA’s Acceptance of sNDA for Jardiance to Treat Type 2 Diabetes

Date: Mar 09, 2023 | Tags: Eli Lilly, Jardiance, Type 2 Diabetes, Regulatory, US, FDA, sNDA  

Astellas and BMT CTN Report P-III Trial (MORPHO) Results of Gilteritinib for the Treatment of Acute Myeloid Leukemia

Date: Mar 09, 2023 | Tags: Astellas, BMT CTN, Gilteritinib, Acute Myeloid Leukemia,Clinical Trial, P-III, MORPHO Trial

OPKO Health’s ModeX Signs an Exclusive Worldwide License and Collaboration Agreement with Merck to Develop MDX-2201 for Epstein-Barr Virus Vaccine

Date: Mar 09, 2023 | Tags: OPKO Health, ModeX, Merck, MDX-2201, Epstein-Barr Virus Vaccine, Pharma 

SpringWorks Published P-III Trial (DeFi) Results of Nirogacestat for Desmoid Tumors in the NEJM

Date: Mar 09, 2023 | Tags: SpringWorks, Nirogacestat, Desmoid Tumors, Clinical Trial, P-III, DeFi Trial, NEJM

Ionis Reports the US FDA’s Acceptance of NDA for Eplontersen to Treat Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Date: Mar 09, 2023 | Tags: Ionis, Eplontersen, Hereditary Transthyretin-Mediated Amyloid Polyneuropathy, Regulatory, US FDA, NDA 

BioMarin's Reports the US FDA’s Acceptance of sNDA for Voxzogo (vosoritide) to Treat Children with Achondroplasia Aged ≤5 Years

Date: Mar 09, 2023 | Tags: BioMarin, Voxzogo, vosoritide, Achondroplasia, Regulatory, US, FDA, sNDA

Medtronic Reports (PULSED AF) Trial Results of PulseSelect PFA System for Atrial Fibrillation

Date: Mar 07, 2023 | Tags: Medtronic, PulseSelect PFA System, Atrial Fibrillation, Clinical Trial, MedTech, PULSED AF Trial

Coherus Receives the US FDA’s Approval of Udenyca (biosimilar, pegfilgrastim) for Febrile Neutropenia

Date: Mar 07, 2023 | Tags: Coherus, Udenyca, pegfilgrastim, Febrile Neutropenia, Regulatory, Biosimilar US, FDA 

Sanofi and Regeneron Report the US FDA’s Acceptance of sBLA of Dupixent (dupilumab) for Chronic Spontaneous Urticaria in Adults and Adolescents

Date: Mar 07, 2023 | Tags: Sanofi, Regeneron, Dupixent, dupilumab, Chronic Spontaneous Urticaria, Regulatory, US, FDA, sBLA

Heron Therapeutics Launches Aponvie for the Management of Postoperative Nausea and Vomiting in the US

Date: Mar 07, 2023 | Tags: Heron Therapeutics, Aponvie, Postoperative Nausea, Vomiting, Pharma, US

Abbott Receives the US FDA Clearance of FreeStyle Libre 2 and FreeStyle Libre 3 Sensors for Diabetes

Date: Mar 07, 2023 | Tags: Abbott, FreeStyle Libre 2, FreeStyle Libre 3 Sensors, Diabetes, Regulatory, MedTech, US, FDA 

Merck Reports P-III Trial (STELLAR) Results of Sotatercept for Pulmonary Arterial Hypertension

Date: Mar 07, 2023 | Tags: Merck, Sotatercept, Pulmonary Arterial Hypertension, Clinical Trial, P-III, STELLAR Trial

Harbour BioMed Reports P-III Trial Results of Batoclimab for the Treatment of Generalized Myasthenia Gravis

Date: Mar 06, 2023 | Tags: Harbour BioMed, Batoclimab, Generalized Myasthenia Gravis, Clinical Trial, P-III Trial 

Daiichi Sankyo and AstraZeneca Report P-II trial (DESTINY-PanTumor02) Results of Enhertu (trastuzumab deruxtecan) for HER2 Expressing Advanced Solid Tumors

Date: Mar 06, 2023 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, trastuzumab deruxtecan, Solid Tumors, Clinical Trial, P-II, DESTINY-PanTumor02 Trial

Abbott Reports Five Year Results of Mitraclip Device for the Treatment of Mitral Regurgitation

Date: Mar 06, 2023 | Tags: Abbott, Mitraclip Device, Mitral Regurgitation, Medtech, NEJM

Amarin Reports (REDUCE-IT) Study Results of Vascepa/Vazkepa (icosapent ethyl) for Acute Coronary Syndrome Event

Date: Mar 06, 2023 | Tags: Amarin, Vascepa, Vazkepa, icosapent ethyl, Acute Coronary Syndrome Event, Clinical Trial, REDUCE-IT Study 

Eisai and Biogen Report the US FDA’s Acceptance of sBLA and Granted Priority Review for Leqembi (lecanemab-irmb) to Treat Alzheimer’s Disease

Date: Mar 06, 2023 | Tags: Eisai, Biogen, Leqembi, lecanemab-irmb, Alzheimer’s Disease, Regulatory, US, FDA, sBLA, Priority Review

BMS’ Reblozyl (luspatercept) Receives EC’s Approval for Anemia in Adult Patients with Non-Transfusion-Dependent Beta Thalassemia

Date: Mar 06, 2023 | Tags: BMS, Reblozyl, luspatercept, Anemia, Non-Transfusion-Dependent Beta Thalassemia, Regulatory, EC, Approval 

Related Post: PharmaShots Weekly Snapshots (February 27 – March 03, 2023)