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News Breaks
July 25, 2014
07:17 EDTGILD, JNJEMA recommends approval for Gilead, Janssen blood cancer drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting, recommended granting marketing authorizations for two new medicines with novel mechanisms of action for the treatment of different forms of rare cancers of the blood. Imbruvica and Zydelig are recommended for authorization in the treatment of adult patients with chronic lymphocytic leukemia who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy. Imbruvica, an orphan medicine, is also recommended for use in the treatment of adult patients with mantle cell lymphoma that has come back after previous treatments or is not responding to other treatments. Zydelig is also to be used for adult patients with follicular lymphoma that has not responded to two previous treatments. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorizations. Once marketing authorisations have been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential role/use of these medicines in the context of the national health system of that country. The marketing-authorization applicant for Imbruvica is Janssen-Cilag International (JNJ) and the marketing-authorization applicant for Zydelig is Gilead Sciences (GILD).
News For GILD;JNJ From The Last 14 Days
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November 14, 2014
11:48 EDTGILDStocks with call strike movement; GILD BBY
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09:38 EDTGILDActive equity options trading
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November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
13:32 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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November 12, 2014
07:53 EDTGILDLeerink to hold a tour
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November 11, 2014
16:14 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.
16:01 EDTGILDOptions Update; November 11, 2014
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11:35 EDTGILDUBS holds a conference call with Gilead Sciences
UBS Biotech Analyst Roden, along with Dr. Bischofberger of Gilead Sciences, discuss the recently-held AASLD Meeting and the outlook of several GILD pipeline programs on a conference call to be held on November 13 at 4:30 pm.
08:07 EDTGILDGilead announces results from Phase 2 and 3 studies evaluating Harvoni
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08:05 EDTGILDGilead announces data from Phase 2 Sofosbuvir plus GS-5816 studies
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November 10, 2014
16:00 EDTGILDOptions Update; November 10, 2014
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09:35 EDTGILDActive equity options trading
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09:20 EDTGILDOn The Fly: Pre-market Movers
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08:48 EDTGILDGilead rises after Merck presents data on HCV combo
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07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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07:20 EDTGILDGilead overhang from Merck HCV combo removed, says Wells Fargo
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