22 documents

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07:00 , Oct 24, 2016 |  BioCentury  |  Strategy

Lilly’s history lesson

  Eli Lilly and Co. President and CEO-in-waiting David Ricks will inherit a well-stocked pipeline, seven drugs less than three years old and a much-improved growth trajectory. To maintain momentum, he’ll have to execute on the...
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07:00 , Jul 11, 2016 |  BC Week In Review  |  Company News

Amgen, Takeda deal

Takeda said it returned its Japanese rights to fulranumab ( AMG 403) and trebananib ( AMG 386) to Amgen. In 2008, Amgen granted exclusive, Japanese rights to Takeda for up to 13 compounds, including the...
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00:22 , Jun 25, 2016 |  BC Extra  |  Company News

Takeda ends Japan deal for two Amgen candidates

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said it returned its Japanese rights to fulranumab ( AMG 403) and trebananib ( AMG 386) to Amgen Inc. (NASDAQ:AMGN). In April, Johnson & Johnson (NYSE:JNJ) said it discontinued Phase...
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01:35 , May 3, 2016 |  BC Extra  |  Top Story

Regeneron's anti-NGF mAb meets Phase II/III endpoint

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said fasinumab ( REGN475) met the primary endpoint of significantly improving pain relief vs. placebo in a Phase II/III study to treat moderate to severe osteoarthritis (OA) pain of the hip...
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07:00 , Apr 11, 2016 |  BC Week In Review  |  Company News

Amgen, J&J deal

The Janssen Research & Development LLC unit of Johnson & Johnson said it will discontinue its Phase III development program for osteoarthritis pain candidate fulranumab due to “strategic portfolio prioritization.” J&J, which had exclusive, worldwide...
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00:09 , Apr 2, 2016 |  BC Extra  |  Company News

Janssen returns Phase III anti-NGF mAb to Amgen

The Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) said it will discontinue its Phase III development program for fulranumab ( AMG 403) to treat osteoarthritis pain. J&J will return the candidate's...
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07:00 , Mar 19, 2012 |  BC Week In Review  |  Clinical News

Fulranumab regulatory update

FDA's Arthritis Drugs Advisory Committee voted 21-0 that anti- nerve growth factor (NGF) agents should continue to be developed to treat osteoarthritis (OA) pain. Because the joint destruction was increased in patients taking anti-NGFs with...
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00:18 , Mar 13, 2012 |  BC Extra  |  Clinical News

Panel backs anti-NGF development for OA

FDA's Arthritis Drugs Advisory Committee voted 21-0 that anti- nerve growth factor (NGF) agents should continue to be developed to treat osteoarthritis pain. Because the joint destruction was increased in patients taking anti-NGFs with NSAIDs,...
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00:45 , Mar 9, 2012 |  BC Extra  |  Company News

FDA panel to consider role of anti-NGF compounds

FDA will ask its Arthritis Advisory Committee on Monday whether there are any populations for which anti- nerve growth factor (NGF) pain products should be developed, given reports of joint destruction seen in clinical trials....
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00:11 , Sep 10, 2011 |  BC Extra  |  Politics & Policy

FDA postpones anti-NGF meeting

FDA postponed the Arthritis Advisory Committee that had been scheduled for Sept. 13 to discuss safety issues possibly related to anti- nerve growth factor (NGF) compounds. The agency said it needs time to review large...
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