08:00 , Dec 16, 2013 |  BioCentury  |  Strategy

Out in the cold

New excluded drugs lists devised by pharmacy benefits managers are raising the hurdle for reimbursement of drugs the PBMs' pharmacy and therapeutics committees consider to be clinically equivalent to cheaper drugs. Drugs that are not...
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)....
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...
07:00 , Aug 15, 2011 |  BC Week In Review  |  Clinical News

Ganetespib: Phase II started

Synta disclosed in its 2Q11 earnings that investigators at the Dana-Farber Cancer Institute began an open-label, U.S. Phase II trial to compare 200 mg/m 2 IV ganetespib given weekly for the first 3 weeks of...
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...
08:00 , Jan 3, 2011 |  BioCentury  |  Finance

Trickle-down effect

Although companies in the $1-$1.9 billion market cap range were the big winners for 2010 with a 28% gain, last quarter saw gains migrate into lower rungs of the market cap ladder. Small caps with...
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...