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8:19 AM, Sep 14, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

CARsgen solid tumor CAR T leads to complete response

member 17; TNFRSF17; CD269) for multiple myeloma, CD19 for B cell leukemia and lymphoma, EGFR/epidermal growth factor
8:18 AM, Sep 14, 2018  |  BC Week In Review | Company News  |  Deals

GNS, Amgen to use AI to explore patient response to mCRC drug Vectibix

GNS Healthcare Inc. (Cambridge, Mass), Amgen Inc. (NASDAQ:AMGN) and the Alliance for Clinical Trials in Oncology (Boston, Mass.) partnered to use artificial intelligence to identify factors that drive and predict patient responses to Amgen’s metastatic...
11:44 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

EC approves Puma's Nerlynx as adjuvant for breast cancer

The European Commission approved Nerlynx neratinib from Puma Biotechnology Inc. (NASDAQ:PBYI) for extended adjuvant treatment of adults with early hormone receptor-positive, HER2-overexpressed/amplified breast cancer within one year of completion of prior adjuvant Herceptin trastuzumab-based therapy....
11:17 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Regulatory

ChiMed scores a China first with fruquitinib approval

Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said China's National Medical Products Administration (NMPA) approved Elunate fruquintinib to treat metastatic colorectal cancer (mCRC). According to Chi-Med, the drug is the first China-discovered and developed product for...
10:52 AM, Sep 07, 2018  |  BC Week In Review | Company News  |  Other News

How an ex-GSK employee funneled trade secrets to Chinese company

necrosis factor α (TNFα), TNF receptor superfamily member 17 (BCMA; TNFRSF17; CD269), HER2 and fibroblast growth factor
11:59 AM, Aug 31, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Japan approves Tagrisso for first-line NSCLC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Japan's Ministry of Health, Labour and Welfare (MHLW) approved Tagrisso osimertinib as a first-line treatment for recurrent EGFR mutation-positive non-small cell lung cancer. The drug was already approved in Japan...
11:45 AM, Aug 31, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves first drug for neurotrophic keratitis

been determined. The European Commission approved the drug in July 2017. The recombinant human nerve growth factor
11:42 AM, Aug 31, 2018  |  BC Week In Review | Clinical News  |  Regulatory

China approves Hengrui breast cancer drug on Phase II data

Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) said China’s State Drug Administration conditionally approved pyrotinib (SHR-1258, HTI-1001) in combination with capecitabine to treat HER2-positive, advanced or metastatic breast cancer in patients previously treated with anthracycline or...
11:33 AM, Aug 31, 2018  |  BC Week In Review | Financial News  |  Proposed Offerings

Principia seeks IPO ahead of Phase III trials for Btk program

Principia Biopharma Inc. (South San Francisco, Calif.) proposed late Aug. 17 to raise $86.3 million in an IPO on NASDAQ and revealed that it raised $49.7 million in a series C round this month. Underwriters...
11:30 AM, Aug 17, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Eisai's Lenvima for first-line HCC

FDA approved Lenvima lenvatinib mesylate from Eisai Co. Ltd. (Tokyo:4523) as first-line treatment of unresectable hepatocellular carcinoma (HCC). The approval was based on data from the Phase III REFLECT trial in patients with previously untreated, metastatic...

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