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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.

FDA accepts refiling of Fotivda for renal cell carcinoma.- AVEO Oncology

Written by | 2 Jun 2020

AVEO Oncology announced that the FDA accepted for filing its New Drug Application (NDA) seeking approval for Fotivda (tivozanib), the Company’s next-generation vascular endothelial growth factor receptor tyrosine… read more.

BioMarin provides highlights of 4 Years of clinical data from ongoing phase 1/II study of valoctocogene roxaparvovec gene therapy for severe hemophilia A.

Written by | 1 Jun 2020

BioMarin Pharmaceutical Inc. announced an update to its previously reported results of an open-label Phase 1/II study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with… read more.

Phase III ASPEN trial of Brukinsa in Waldenström’s macroglobulinemia shows positive follow-up data.- BeiGene

Written by | 31 May 2020

BeiGene announced follow-up data from the Phase III ASPEN trial comparing BRUKINSA (zanubrutinib) to ibrutinib for the treatment of Waldenström’s macroglobulinemia. Data presented from the Phase III ASPEN… read more.

CHMP recommends Zercepac for treating breast or gastric cancer.- Accord Healthcare

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zercepac (trastuzumab), from Accord… read more.

CHMP recommends approval of Hepcludex for chronic hepatitis delta virus.- Myr

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Hepcludex (bulevirtide), from MYR GmbH, intended… read more.

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