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Sarclisa + Kyprolis + dexmethasone demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma. Sanofi

Written by | 3 Jun 2020

Sarclisa (isatuximab) added to carfilzomib and dexamethasone (Sarclisa combination therapy) reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007, n=179)… read more.

Pfizer provides update on Phase III PALLAS trial of Ibrance + endocrine therapy in HR+, HER 2- early breast cancer.

Written by | 3 Jun 2020

As announced by the Austrian Breast & Colorectal Cancer Study Group and the Alliance Foundation Trials, LLC, Pfizer Inc. reports that following a preplanned efficacy and futility analysis,… read more.

Myovant Sciences has submitted an NDA to the FDA for its once-daily relugolix for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

Written by | 3 Jun 2020

Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and… read more.

European Commission approves Sarclisa + Pomalyst + dexamethasone to treat relapsed.- and refractory multiple myeloma – Sanofi

Written by | 3 Jun 2020

The European Commission (EC) has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) from Sanofi for the treatment of adult patients with relapsed and refractory multiple… read more.

FDA extends PDUFA review date for subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis to September 2020.-Novartis.

Written by | 3 Jun 2020

Genmab A/S announced that the FDA has notified Novartis that the agency has extended its review of the supplemental Biologics License Application (sBLA) for subcutaneous ofatumumab for the… read more.

Phase II DESTINY-CRC01 trial of Enhertu/Enhurtu demonstrated meaningful activity in patients with HER2 positive unresectable and/or metastatic colorectal cancer.- Daiichi Sankyo + AstraZeneca

Written by | 2 Jun 2020

Results from the phase II DESTINY-CRC01 trial of Daiichi Sankyo Company, Limited and AstraZeneca’s Enhurtu (fam-trastuzumab deruxtecan-nxki) demonstrated clinically meaningful activity in patients with HER2 positive unresectable and/or… read more.

SURE 2 phase III clinical trial of sulopenem fails to meet endpoint in complicated urinary tract infection.- Iterum Therapeutics

Written by | 2 Jun 2020

Iterum Therapeutics announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 phase III clinical trial in complicated urinary… read more.

Phase II DESTINYLung01 trial positive for Enhertu/Enhurtu in HER2 mutant NSCLC.- Daiichi Sankyo and AstraZeneca.

Written by | 2 Jun 2020

Results from the ongoing phase II DESTINYLung01 trial showed Daiichi Sankyo Company, Limited and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) achieved a clinically meaningful tumor response in patients with HER2… read more.

VBL presents positive interim data from the OVAL phase III pivotal study of VB 111 in ovarian cancer at the ASCO meeting, showing 58% or higher objective response rate

Written by | 2 Jun 2020

VBL Therapeutics announced the presentation of the positive outcome of pre-planned interim analysis results from the OVAL Phase III pivotal clinical trial of VB III in platinum-resistant ovarian… read more.

Brilinta approved by FDA to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease .-AstraZeneca

Written by | 2 Jun 2020

AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD),… read more.

Gilead announces results from phase III trial of remdesivir in patients with moderate COVID-19.- Gilead Sciences.

Written by | 2 Jun 2020

Gilead Sciences, Inc. announced topline results from the Phase iII SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of… read more.

FDA approves supplemental BLA for Taltz for the treatment of active non-radiographic axial spondyloarthritis.- Eli Lilly

Written by | 2 Jun 2020

Eli Lilly and Company announced the FDA has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial… read more.

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