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News Breaks
March 25, 2014
07:09 EDTEXELExelixis announces Cometriq approved in Europe
Exelixis announced that the European Commission has approved Cometriq for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma, or MTC. The European Commission granted conditional marketing authorisation following a positive opinion from the European Committee for Medicinal Products for Human Use, or CHMP, issued in December 2013. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions. The Committee for Orphan Medicinal Products also reviewed the designation for Cometriq as an orphan medicinal product for the treatment of MTC, and recommended maintenance of orphan drug designation at the time of marketing authorisation.
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December 15, 2014
05:24 EDTEXELExelixis announces Genentech files NDA for cobimetinib, vemurafenib combination
Exelixis (EXEL) announced its collaborator Genentech, a member of the Roche Group (RHHBY), has completed the filing of its New Drug Application, or NDA, with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
December 11, 2014
07:28 EDTEXELCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.

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