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News Breaks
July 22, 2014
05:21 EDTRHHBYRoche announces Genentech Avastin granted priority review by FDA
Genentech, a member of the Roche Group, announced that the FDA has accepted the company's supplemental Biologics License Application, or sBLA, and granted Priority Review for Avastin plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The sBLA for Avastin plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the Phase III AURELIA trial with an FDA action date of November 19.
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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