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April 16, 2013
11:36 EDTGSK, RHHBY, BIIBAppeals court upholds ruling in patent suit between Glaxo, Biogen
Biogen Idec (BIIB) and Roche's (RHHBY) Genentech unit appealed a district court’s construction of a disputed claim term, “anti-CD20 antibody,” that narrowed the term in their patent dispute with GlaxoSmithKline (GSK). An appeals court concluded that "the district court did not err in finding a clear and unmistakable disclaimer" and affirmed the lower court's decision. Reference Link
News For BIIB;RHHBY;GSK From The Last 14 Days
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January 28, 2015
05:49 EDTRHHBYRoche sees 2015 sales growth in low- to mid-single digit
Roche expects sales to grow low- to mid-single digit, at constant exchange rates for 2015. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:48 EDTRHHBYRoche reports 2014 core EPS CHF14.29 vs. CHF14.27 last year
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January 27, 2015
15:35 EDTBIIBNotable companies reporting before tomorrow's open
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15:26 EDTBIIBBiogen January weekly volatility elevated into Q4 and outlook
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14:00 EDTRHHBYRoche to hold a meeting with a conference call hookup
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January 26, 2015
09:19 EDTGSKGlaxoSmithKline announces availability of two new products for asthma
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05:15 EDTRHHBYRoche receives FDA clearance for next generation cobas MRSA/SA test
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January 23, 2015
08:52 EDTGSKArray BioPharma to hold a conference call
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08:17 EDTRHHBYRoche management to meet with JPMorgan
Meeting to be held in New York on January 29 hosted by JPMorgan.
08:10 EDTGSKArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:44 EDTGSKGlaxo says now in position to deliver 'tens of thousands' of Ebola vaccine doses
Witty expects to start seeing data from trials of Ebola vaccines in next four to five months. GlaxoSmithKline CEO Andrew Witty speaking on CNBC.
06:39 EDTGSKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 21, 2015
12:30 EDTGSKGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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09:02 EDTRHHBYRoche's Ventana seeks FDA premarket approval for ALK IHC lung cancer assay
Roche Group member Ventana Medical Systems announced its FDA submission for premarket approval of the Ventana ALK CDx Assay. The companion diagnostic immunohistochemistry test is designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene. This submission was the fourth and final module and application required by the FDA's PMA process.
January 16, 2015
16:36 EDTRHHBYMarket finishes week lower on continued oil, global growth worries
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08:31 EDTGSKGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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06:21 EDTRHHBYRoche acquires Trophos for EUR120M plus contingent payments
Roche has agreed to acquire Trophos, a privately held biotechnology company based in Marseille, France. Trophos’s proprietary screening platform generated olesoxime, TRO19622, which is being developed for SMA – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease. These data were first presented in April 2014 at the annual meeting of the American Academy of Neurology. Under the terms of the agreement, Trophos’s shareholders will receive an upfront cash payment of EUR 120M, plus additional contingent payments of up to EUR 350M based on achievement of certain predetermined milestones.
January 15, 2015
14:31 EDTGSKMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
08:36 EDTGSKOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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07:29 EDTBIIBOutlook for Biogen trials positive , says RBC Capital
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