Daily Top News – July 8, 2020

July 8, 2020

Rozlytrek (entrectinib) / Roche
Thermo Fisher closes deal with Roche for companion diagnostic for entrectinib (SeekingAlpha) – Jul 8, 2020 – “Thermo Fisher Scientific…inks an agreement with Roche…unit Chugai Pharmaceutical Co., Ltd. to expand the use of TMO’s Oncomine Dx Target Test as a companion diagnostic to identify ROS1-positive non-small cell lung cancer patients who may be suitable for Roche’s Rozlytrek (entrectinib)…Chugai has submitted an application to Japan’s Ministry of Health, Labor and Welfare seeking approval for the expanded use of the test….TMO says that Oncomine Dx Target Test is currently reimbursed by both private insurers and governments in the U.S., Europe, Japan and South Korea.”

 

aducanumab (BIIB037) / Eisai, Biogen
BIOGEN COMPLETES SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR ADUCANUMAB AS A TREATMENT FOR ALZHEIMER’S DISEASE (Biogen Press Release) – Jul 8, 2020 – “Biogen…and Eisai Co., Ltd….today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimer’s disease. The completed submission followed ongoing collaboration with the FDA and includes clinical data from the Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1b PRIME study. As part of the completed submission, Biogen has requested Priority Review.”

 

Keytruda (pembrolizumab) / Merck (MSD); Lenvima (lenvatinib) / Eisai, Merck (MSD)
Merck and Eisai Receive Complete Response Letter for KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma (Businesswire) – Jul 8, 2020 – “Merck…and Eisai today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s and Eisai’s applications seeking accelerated approval of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The applications were based on data from the Phase 1b KEYNOTE-524/Study 116 trial…”

 

Tazverik (tazemetostat) / Epizyme, Eisai
EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION IN JAPAN FOR ANTICANCER AGENT TAZEMETOSTAT FOR EZH2 GENE MUTATION-POSITIVE FOLLICULAR LYMPHOMA (Eisai Press Release) – Jul 8, 2020 – “Eisai Co., Ltd…announced today that it has submitted a marketing authorization application in Japan for the EZH2 inhibitor tazemetostat hydrobromide (generic name, development code: E7438, ‘tazemetostat’) for EZH2 gene mutation-positive follicular lymphoma….This application is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 206) in Japan conducted by Eisai and other studies conducted by Epizyme, Inc. (Headquarters: Massachusetts, United States) outside Japan.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer (AstraZeneca Press Release) – Jul 8, 2020 – “AstraZeneca and MSD…today announced that Lynparza (olaparib) has been approved in the European Union (EU) for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer….The approval by the European Commission was based on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.”

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