PharmaShots Weekly Snapshots (April 19 – 23, 2021)

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML

Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML

Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan

Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, Filgotinib, PMDA, Ulcerative Colitis, Japan

AbbVie’s Humira (adalimumab) Receives Health Canada’s Approval for Pediatric Patients with Active Ulcerative Colitis

Published: Apr 23, 2021 | Tags: AbbVie, Humira (adalimumab), Receives, Health Canada, Approval, Pediatric, Patients, Active, Ulcerative Colitis

GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Approval for dMMR Endometrial Cancer

Published: Apr 23, 2021 | Tags: GSK, Jemperli (dostarlimab-gxly), Receives, US, FDA, Approval, dMMR, Endometrial Cancer

Roche Receives the US FDA’s Approval for First CDx to Identify Endometrial Cancer Patients Eligible for Immunotherapy

Published: Apr 23, 2021 | Tags: Roche, Receives, US, FDA, Approval, First, CDx, Identify, Endometrial Cancer, Patients, Eligible, Immunotherapy

Vertex Signs a License Agreement with Obsidian Therapeutics to Discover Regulated Gene Editing Therapies

Published: Apr 23, 2021 | Tags: Vertex, Signs, License Agreement, Obsidian Therapeutics, Discover, Regulated, Gene Editing, Therapies

Claritas Collaborates with CMAX to Initiate P-I Study of R-107 for Pulmonary Arterial Hypertension

Published: Apr 22, 2021 | Tags: Claritas, Collaborates, CMAX, Initiate, P-I Study, R-107, Pulmonary Arterial Hypertension

Johnson & Johnson Publishes Results of COVID-19 Single Shot Vaccine in NEJM

Published: Apr 22, 2021 | Tags: Johnson & Johnson, Publishes, Results, COVID-19, Single Shot,, Vaccine, NEJM

AgeneBio Reports Completion of Patient Enrollment in P-IIB HOPE4MCI Trial for AGB101 to Treat Amnestic Mild Cognitive Impairment due to Alzheimer Disease

Published: Apr 22, 2021 | Tags: AgeneBio, Reports, Completion, Patient Enrollment, P-IIB HOPE4MCI Trial, AGB101, Treat, Amnestic Mild Cognitive Impairment, Alzheimer Disease

TG Therapeutics Initiates Patient Enrolment in P-III ULTRA-V Trial for Triple Combination Regimen to Treat R/R Chronic Lymphocytic Leukemia

Published: Apr 22, 2021 | Tags: TG Therapeutics, Initiates, Patient Enrolment, P-III ULTRA-V Trial, Triple Combination Regimen, Treat, R/R Chronic Lymphocytic Leukemia

Novo Nordisk to Initiate P-IIIa Study for Oral Semaglutide to Treat Obesity

Published: Apr 22, 2021 | Tags: Novo Nordisk, Initiate, P-IIIa Study, Oral Semaglutide, Treat, Obesity

Medtronic Receives the US FDA’s Approval for Pipeline Flex Embolization Device with Shield Technology

Published: Apr 22, 2021 | Tags: Medtronic, Receives, US, FDA, Approval, Pipeline, Flex Embolization Device, Shield Technology

LEXEO Therapeutics Receives the US FDA’s Fast Track Designation for LX1001 to Treat APOE4 Associated Alzheimer Disease

Published: Apr 21, 2021 | Tags: LEXEO Therapeutics, Receives, US, FDA, Fast Track Designation, LX1001, Treat, APOE4, Associated, Alzheimer Disease

GW Pharmaceuticals’ Epidyolex (cannabidiol) Receives EC’s Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex

Published: Apr 21, 2021 | Tags: GW Pharmaceuticals, Epidyolex (cannabidiol), Receives, EC, Approval, Treatment, Seizures, Associated, Tuberous Sclerosis Complex

Janssen Collaborates with PhysIQ for Wearable Biosensors and Digital Biomarkers Initiatives

Published: Apr 21, 2021 | Tags: Janssen, Collaborates, PhysIQ, Wearable Biosensors, Digital Biomarkers Initiatives

SparingVision Acquires GAMUT Therapeutics to Expands its Novel Ocular Disease Pipeline

Published: Apr 21, 2021 | Tags: SparingVision, Acquires, GAMUT Therapeutics, Expands, Novel, Ocular Disease Pipeline

Jazz Presents Results of Xywav (Oral Solution) in P-III Withdrawal Study for Adult Patients with Idiopathic Hypersomnia at AAN2021

Published: Apr 21, 2021 | Tags: Jazz, Presents, Results, Xywav (Oral Solution), P-III Withdrawal Study, Adult Patients, Idiopathic Hypersomnia

Vertex Amend its Collaboration with CRISPR Therapeutics for Development and Commercialization of CTX001 in SCD and Beta Thalassemia

Published: Apr 21, 2021 | Tags: Vertex, Amend, Collaboration, CRISPR Therapeutics, Development,  Commercialization, CTX001, SCD, Beta Thalassemia

Lilly and Incyte Report Results of Baricitinib in P-III BRAVE-AA1 Study for Severe Alopecia Areata

Published: Apr 20, 2021 | Tags: Lilly and Incyte, Report, Results, Baricitinib, P-III BRAVE-AA1 Study, Severe Alopecia Areata

Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval for Patients with Newly Diagnosed Light Chain Amyloidosis

Published: Apr 20, 2021 | Tags: Janssen, Darzalex (daratumumab, SC), Combination Regimen, Receives, Health Canada, Approval, Patients, Newly Diagnosed, Light Chain Amyloidosis

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease

Published: Apr 20, 2021 | Tags: Biogen, Eisai, Report, Results, Lecanemab (BAN2401), P-IIb Study 201, Patients, Early Alzheimer Disease

Alnylam Presents Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy at AAN 2021

Published: Apr 20, 2021 | Tags: Alnylam, Presents, Results, Vutrisiran, P-III HELIOS-A Study, Patients, hATTR Amyloidosis, Polyneuropathy

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Published: Apr 20, 2021 | Tags: Astellas, Seagen, Report, US, FDA, Acceptance, Two, sBLA, Padcev (enfortumab vedotin), Locally, Advanced, Metastatic, Urothelial Cancer

Incyte and MorphoSys Report First Patient Dosing in P-III inMIND Study for Relapsed or Refractory Follicular or Marginal Zone Lymphoma

Published: Apr 20, 2021 | Tags: Incyte, MorphoSys, Report, First, Patient Dosing, P-III inMIND Study, Relapsed, Refractory, Follicular, Marginal Zone Lymphoma

Novartis Reports Results of Kesimpta (ofatumumab) in P- III ASCLEPIOS Trials for Newly Diagnosed Patients with RMS

Published: Apr 19, 2021 | Tags: Novartis, Reports, Results, Kesimpta (ofatumumab), P- III ASCLEPIOS Trials, Newly Diagnosed, Patients, RMS

Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

Published: Apr 19, 2021 | Tags: Janssen, Presents, Results, Nipocalimab (M281), P-II Vivacity-MG Study, Adults, Generalized Myasthenia Gravis

Evotec Signs a License Agreement with Kazia Therapeutics for Clinical Development of EVT801

Published: Apr 19, 2021 | Tags: Evotec, Signs, License Agreement, Kazia Therapeutics, Clinical Development

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma

Published: Apr 19, 2021 | Tags: Sanofi, Sarclisa (isatuximab), Receives, EC, Approval, Adults, Relapsed, Refractory, Multiple Myeloma

Lilly and Incyte Report Results of Baricitinib in P-III COV-BARRIER Study for Hospitalized Patients with COVID-19

Published: Apr 19, 2021 | Tags: Lilly and Incyte, Report, Results, Baricitinib, P-III COV-BARRIER Study, Hospitalized Patients, COVID-19

Zogenix Presents Results of Fintepla’s (fenfluramine) Study Highlighting the Impact of Treatment on Dravet Syndrome Patients, Caregivers, and Families at AAN 2021

Published: Apr 19, 2021 | Tags: Zogenix, Presents, Results, Fintepla (fenfluramine) Study, Highlighting, Impact, Treatment, Dravet Syndrome Patients, Caregivers, Families

Related Post: PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)