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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...
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...
11:30 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...
8:31 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA gives green light for Regeneron's 12-week Eylea regimen

The drug is a human fusion protein that binds all forms of VEGF-A and placental growth factor
1:07 PM, Jul 13, 2018  |  BC Week In Review | Clinical News  |  Regulatory

EMA's CHMP recommends CAR Ts, rare disease therapies

adjuvant treatment for breast cancer, reversing a prior recommendation. Nerlynx is an inhibitor of epidermal growth factor
1:23 PM, Jun 15, 2018  |  BC Week In Review | Clinical News  |  Regulatory

EC approves Tagrisso for NSCLC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said the European Commission approved Tagrisso osimertinib as a first-line treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations. The approval was based...
12:12 PM, May 18, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Ipsen's Cabometyx MAA approved, Exelixis takes home $50M

Ipsen Group (Euronext:IPN; Pink:IPSEY) said the European Commission approved an MAA for Cabometyx cabozantinib to treat first-line renal cell carcinoma, triggering a $50 million milestone payment to partner Exelixis Inc. (NASDAQ:EXEL). Cabometyx will now be...

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