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News Breaks
March 13, 2014
03:18 EDTRHHBYFDA advisory committee unanimously recommends Roche's cobas HPV test
Roche announced that the U.S. FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV Test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. The panel also voted unanimously that the cobas HPV Test is safe and effective for the proposed indication for use. If approved, the cobas HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States. The Committee's recommendation will be considered by the FDA in its review of the primary screening indication for the cobas HPV Test. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing medical devices.
News For RHHBY From The Last 14 Days
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October 28, 2014
11:14 EDTRHHBYRoche unit announces collaboration pact with ImmunoGen
Ventana Medical Systems, a member of the Roche Group (RHHBY), announced it has entered into an agreement with ImmunoGen (IMGN) to collaborate on the development of biomarker assays and a companion diagnostic immunohistochemistry test for one or more of ImmunoGen's product candidates. Under this agreement, the companies have created an initial test for folate receptor alpha, or FRa, that is being used in early trials of IMGN853, ImmunoGen's FRa-targeting antibody-drug conjugate.
October 27, 2014
20:54 EDTRHHBYLeerink's major pharma analyst holds an analyst/industry conference call
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07:20 EDTRHHBYAmerican Association of Blood Banks to hold annual meeting
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October 24, 2014
12:03 EDTRHHBYRoche reports CHMP recommends label update for Esbriet
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October 21, 2014
07:15 EDTRHHBYFDA to hold workshop on breast cancer drug development
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October 20, 2014
12:37 EDTRHHBYOn The Fly: Midday Wrap
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07:19 EDTRHHBYIBC Life Sciences to hold a conference
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07:11 EDTRHHBYAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTRHHBYAmerican Society of Human Genetics to hold annual meeting
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07:06 EDTRHHBYNewLink announces worldwide license agreement for NLG919 development
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07:04 EDTRHHBYRoche approval would be positive for TESARO, says Jefferies
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