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Category: Larvol Pulse News

Daily Top News – May 11, 2020

May 11, 2020

Avastin (bevacizumab) / Roche; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer (AstraZeneca Press Release) – May 11, 2020 – “Regulatory reviews are currently underway in the EU, Japan and other countries for Lynparza based on results from the PAOLA-1 trial.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu granted Breakthrough Therapy Designation in the U.S. for HER2 positive metastatic gastric cancer (Businesswire) – May 11, 2020 – “Daiichi Sankyo Company, Limited…and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab….The FDA granted the BTD based on data from the pivotal phase 2 DESTINY-Gastric01 trial and data from the phase 1 trial published in The Lancet Oncology.”

 

Abbott receives FDA emergency use authorization for Covid-19 antibody blood test on Alinity i system (PRNewswire) – May 11, 2020 – “Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT® and Alinity i™ platforms and will have capacity for 60 million tests in June….Abbott also expects to submit this week for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test.”

 

Zygel (cannabidiol gel) / Zynerba
Zynerba Pharmaceuticals reports first quarter 2020 financial results and operational highlights (GlobeNewswire) – May 11, 2020 – “Topline Results Expected from Pivotal CONNECT-FX Trial Late in the Second Quarter of 2020….If the results are positive, Zynerba intends to request a meeting with the FDA to determine the acceptability of the data as a basis for a New Drug Application (NDA) and to seek advice on preparation of the marketing authorization….Robust Enrollment Continues into Open Label Extension Study….As of May 8, 2020, 96% of the 188 patients who have completed the 14-week blinded portion of the CONNECT-FX trial have enrolled in the open label extension trial.”

 

envafolimab (KN035) / 3DMed, Tracon
TRACON Pharmaceuticals announces successful type B meeting with FDA for pivotal study of envafolimab in sarcoma (GlobeNewswire) – May 11, 2020 – “TRACON Pharmaceuticals…announced the successful completion of a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA). The FDA agreed with TRACON’s proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). TRACON expects to initiate enrollment in the ENVASARC trial in the second half of 2020.”

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