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News Breaks
July 17, 2014
07:18 EDTGSK, MYLMylan wins motion to enjoin GlaxoSmithKline from production of generic product
Mylan's (MYL) motion for a permanent injunction against GlaxoSmithKline (GSK) in relation to Paroxetine CR, the generic version of GSK's Paxil CR, has been granted by the U.S. District Court for the District of New Jersey. GSK is now precluded from supplying product to Apotex, which marketed the product as an authorized generic. Mylan had previously been awarded damages in the amount of $106.7M by the District Court after a favorable jury verdict in March. In addition, the District Court awarded Mylan prejudgment interest and permitted it to take an accounting so that Mylan can determine the amount of additional damages it has suffered since Sept. 30, 2013 as a result of GSK's ongoing breach. All of GSK's post-trial motions were denied.
News For MYL;GSK From The Last 14 Days
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January 29, 2015
11:19 EDTMYLMylan shareholders approve acquisition of Abbott's generics business
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09:13 EDTMYLAbbott sees 6% negative impact to FY sales from forex
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January 28, 2015
11:38 EDTGSKEC clears GlaxoSmithKline, Novartis deals, with conditions
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11:34 EDTMYLEC clears Abbott sale of non-U.S. EPD-DM business to Mylan, with conditions
The European Commission has cleared under the EU Merger Regulation the proposed acquisition of Abbott Laboratories' (ABT) Non-U.S. Developed Markets Specialty and Branded Generics Business, or EPD-DM, by Mylan (MYL). The decision is conditional upon the divestment of a number of Mylan's businesses in Germany, the United Kingdom, France, Ireland and Italy. The Commission had concerns that the transaction, as initially notified, would have reduced competition on the market for several medicines. The commitments offered by Mylan address these concerns, the EC said.
January 26, 2015
11:00 EDTMYLMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
09:19 EDTGSKGlaxoSmithKline announces availability of two new products for asthma
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January 23, 2015
08:52 EDTGSKArray BioPharma to hold a conference call
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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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January 20, 2015
14:37 EDTMYLTeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTMYLMylan says continues to believe '808 patent is 'invalid'
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10:40 EDTMYLMomenta Pharma sinks after Supreme Court rules on Copaxone
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January 16, 2015
08:31 EDTGSKGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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