Logo

PharmaShots Weekly Snapshots (March 06 - 10, 2023)

Share this

PharmaShots Weekly Snapshots (March 06 - 10, 2023)

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)


Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions