08:00 , Nov 18, 2013 |  BC Week In Review  |  Clinical News

Duodart dutasteride/tamsulosin regulatory update

Germany's Federal Joint Committee (G-BA) said it plans to assess 12 drugs launched before drug pricing law AMNOG came into effect in January 2011, including Duodart dutasteride/tamsulosin from GlaxoSmithKline to treat benign prostatic hyperplasia (BPH)....
07:00 , Aug 19, 2013 |  BC Week In Review  |  Clinical News

Proscar finasteride: Clinical trial data

Data from 18,880 men in an 18-year follow-up study to the Prostate Cancer Prevention Trial (PCPT) showed that 5 mg daily finasteride for 7 years did not significantly improve survival vs. placebo. Specifically, 15-year survival...
08:00 , Feb 6, 2012 |  BC Week In Review  |  Clinical News

Avodart dutasteride: Phase IV data

GlaxoSmithKline markets Avodart in over 90 countries to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Last year, the pharma said it would no longer pursue approval of and subsequently...
01:18 , Jun 10, 2011 |  BC Extra  |  Company News

FDA issues warning on BPH drugs

FDA said it updated the labels for 5-alpha reductase inhibitors to include information about an increased risk of high-grade prostate cancer. The agency said the risk "appears to be low." The change followed FDA's review...
08:00 , Jan 31, 2011 |  BC Week In Review  |  Clinical News

Avodart dutasteride regulatory update

FDA issued a complete response for an sNDA from GlaxoSmithKline for Avodart dutasteride to reduce the risk of prostate cancer in men at increased risk of the disease. GSK would not disclose the contents of...
01:56 , Jan 28, 2011 |  BC Extra  |  Company News

Complete response for GSK's Avodart

FDA issued a complete response for an sNDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Avodart dutasteride to reduce the risk of prostate cancer in men at increased risk of the disease. GSK would not disclose...
01:27 , Dec 2, 2010 |  BC Extra  |  Company News

ODAC rebuffs Proscar, Avodart for prostate cancer

FDA's Oncologic Drugs Advisory Committee voted Wednesday against recommending approval of two benign prostatic hyperplasia (BPH) drugs for prostate cancer: Proscar finasteride from Merck & Co. Inc. (NYSE:MRK) and Avodart dutasteride from GlaxoSmithKline plc (LSE:GSK;...
07:00 , Nov 1, 2010 |  BC Week In Review  |  Clinical News

Avodart dutasteride regulatory update

FDA's Oncologic Drugs Advisory Committee will meet on Dec. 1 to discuss sNDAs for Avodart dutasteride from GlaxoSmithKline and Proscar finasteride from Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.). GSK is seeking to expand...
07:00 , Nov 1, 2010 |  BC Week In Review  |  Clinical News

Proscar finasteride regulatory update

FDA's Oncologic Drugs Advisory Committee will meet on Dec. 1 to discuss sNDAs for Avodart dutasteride from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.) and Proscar finasteride from Merck. GSK is seeking to expand the label...
07:00 , Jun 21, 2010 |  BC Week In Review  |  Clinical News

Jalyn dutasteride/tamsulosin regulatory update

FDA approved an NDA from GlaxoSmithKline for Jalyn dutasteride/tamsulosin to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The company expects to launch the fixed-dose combination of a 5-alpha reductase inhibitor...