PharmaShots Weekly Snapshots (May 17 – 21, 2021)

BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Published: May 21, 2021 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer

Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR 2021

Published: May 21, 2021 | Tags: Aurinia, Lupkynis, voclosporin, AURORA 2 Continuation Study, Lupus Nephritis, EULAR 2021

Takeda Reports the US FDA’s Acceptance and Priority Review of Maribavir’s NDA for Post-Transplant CMV Infection

Published: May 21, 2021 | Tags: Takeda, US, FDA, Priority Review, Maribavir, NDA, Post-Transplant CMV Infection

Astellas and Seagen Report Updated Results of Padcev in Two Studies for Locally Advanced or Metastatic Urothelial Cancer Not Eligible for Cisplatin Chemotherapy

Published: May 21, 2021 | Tags: Astellas, Seagen, Padcev, Two, Studies, Locally Advanced,  Metastatic Urothelial Cancer

AstraZeneca’s Vaxzevria (AZD1222) Receives Approval for Emergency Use in Japan to Treat COVID-19

Published: May 21, 2021 | Tags: AstraZeneca, Vaxzevria, AZD1222, Approval, Emergency Use, Japan COVID-19

Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan

Published: May 21, 2021 | Tags: Moderna, COVID-19 Vaccine, Approval, Emergency Use, Japan

Lilly Reports Results of Tirzepatide in SURPASS-4 Study for Patients with Type 2 Diabetes

Published: May 20, 2021 | Tags: Lilly, Tirzepatide, SURPASS-4 Study, Type 2 Diabetes

Janssen to Present Results of Imbruvica (ibrutinib)-based Combination Regimen as 1L Treatment for Chronic Lymphocytic Leukemia at ASCO

Published: May 20, 2021 | Tags: Janssen, Imbruvica, ibrutinib, Combination Regimen, Chronic Lymphocytic Leukemia, ASCO

Allogene Reports Results of ALLO-501 and ALLO-501A in P-I Studies for Relapsed/Refractory Non-Hodgkin Lymphoma

Published: May 20, 2021 | Tags: Allogene, ALLO-501, ALLO-501A, P-I, Studies, Relapsed/Refractory Non-Hodgkin Lymphoma

Janssen Reports Updated Data of Amivantamab + Lazertinib in P-I CHRYSALIS Study for EGFR-Mutated NSCLC

Published: May 20, 2021 | Tags: Janssen, Amivantamab, Lazertinib, P-I, CHRYSALIS Study, EGFR-Mutated NSCLC

Takeda Presents Results of Mobocertinib in P-I/II Study for Patients with EGFR Exon20 Insertion+ mNSCLC

Published: May 20, 2021 | Tags: Takeda, Mobocertinib, P-I/II, Study, EGFR Exon20 Insertion+ mNSCLC

Genentech Reports Results of Tecentriq in P-III IMpower010 Study for 1L Treatment of NSCLC

Published: May 20, 2021 | Tags: Genentech, Tecentriq, P-III, IMpower010 Study, NSCLC

BioXcel Reports the US FDA’s Acceptance of BXCL501’s NDA for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II

Published: May 19, 2021 | Tags: BioXcel, US, FDA, BXCL501, NDA, Agitation, Schizophrenia, Bipolar Disorders I and II

BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery

Published: May 19, 2021 | Tags: BMS, Exscientia, AI, Driven Drug Discovery

Janssen Signs an Option and License Agreement with Mestag to Discover Novel Fibroblast Targets for Inflammatory Disease

Published: May 19, 2021 | Tags: Janssen, Mestag, Discover, Novel Fibroblast Targets, Inflammatory Disease

Glaukos Expands its Partnership with Santen for Preserflo MicroShunt

Published: May 19, 2021 | Tags: Glaukos, Partnership, Santen, Preserflo MicroShunt

Sarepta’s SRP-9001 Demonstrates Robust Expression and Safety Results in ENDEAVOR Study for DMD

Published: May 19, 2021 | Tags: Sarepta, SRP-9001, Robust Expression, Safety Results, ENDEAVOR Study, DMD

BMS Signs an Exclusive Global License with Agenus for its Anti-TIGIT Bispecific Antibody Program

Published: May 19, 2021 | Tags: BMS, Global License, Agenus, Anti-TIGIT, Bispecific Antibody Program

BlueRock Collaborates with Fujifilm and Opsis to Discover and Develop Cell Therapies for Eye Diseases

Published: May 18, 2021 | Tags: BlueRock, Fujifilm, Opsis, Discover, Develop, Cell Therapies, Eye Diseases

Medicago and GSK Report Results of Plant-Derived Vaccine in a P-II Study for COVID-19

Published: May 18, 2021 | Tags: Medicago, GSK, Plant-Derived Vaccine, P-II Study, COVID-19

Roche Receives the US FDA’s EUA for cobas SARS-CoV-2 Test to Suspect COVID-19

Published: May 18, 2021 | Tags: Roche, US, FDA, EUA, cobas SARS-CoV-2 Test, COVID-19

Eli Lilly and Innovent Report the US FDA’s Acceptance of Sintilimab + Chemotherapy’s BLA for 1L Treatment for Non-Squamous NSCLC

Published: May 18, 2021 | Tags: Eli Lilly, Innovent, US, FDA, Sintilimab, Chemotherapy, BLA, Non-Squamous NSCLC

Regeneron and Sanofi Present Results of Dupixent (dupilumab) in P-III VOYAGE Study for Asthma at ATS 2021

Published: May 18, 2021 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, P-III, VOYAGE Study, Asthma, ATS 2021

Abbott Receives CE Mark for Next-Generation Navitor TAVI System to Treat Aortic Stenosis

Published: May 18, 2021 | Tags: Abbott, CE Mark, Next-Generation, Navitor TAVI System, Aortic Stenosis

Charles River to Acquire Vigene Biosciences for $292.5M

Published: May 17, 2021 | Tags: Charles River, Vigene Biosciences, $292.5M

Apellis’ Empaveli (pegcetacoplan) Receives the US FDA’s Approval for Paroxysmal Nocturnal Hemoglobinuria

Published: May 17, 2021 | Tags: Apellis, Empaveli, pegcetacoplan, US, FDA, Approval, Paroxysmal Nocturnal Hemoglobinuria

PerkinElmer to Acquire Immunodiagnostic Systems Holdings for ~$155M

Published: May 17, 2021 | Tags: PerkinElmer, Immunodiagnostic Systems Holdings, ~$155M

Sanofi and GSK Report Results of its COVID-19 Vaccine in a P-II Study Across All Adult Age Groups

Published: May 17, 2021 | Tags: Sanofi, GSK, COVID-19 Vaccine, P-II Study, Adult Age Groups

BMS Presents Results of Mavacamten in P-III Study for Obstructive Hypertrophic Cardiomyopathy at ACC 2021

Published: May 17, 2021 | Tags: BMS, Mavacamten, P-III Study, Obstructive Hypertrophic Cardiomyopathy, ACC 2021

Biogen’s BIIB112 (cotoretigene toliparvovec) Fails to Meet its Primary Endpoint in P-II/III XIRIUS Study for XLRP

Published: May 17, 2021 | Tags: Biogen, BIIB112, cotoretigene toliparvovec, Primary Endpoint, P-II/III, XIRIUS Study, XLRP

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