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News Breaks
June 9, 2014
07:34 EDTMYL, BMYMylan launches generic version of Bristol-Myers' Paraplatin
Mylan (MYL) announced the launch of carboplatin injection 50mg / 5 ml, in multi-dose vials, which is the generic version of Bristol-Myers' (BMY) Paraplatin injection. Mylan received final FDA approval for its ANDA for this product and also received final approval from the FDA for 150 mg/ 15 ml, 450 mg / 45 ml, and 600 mg / 60 ml versions, which it intends to launch subsequently.
News For MYL;BMY From The Last 14 Days
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January 28, 2015
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 27, 2015
07:37 EDTBMYBristol-Myers sees FY15 EPS $1.55-$1.70, consensus $1.71
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07:31 EDTBMYBristol-Myers reports Q4 EPS 46c, consensus 41c
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January 26, 2015
15:40 EDTBMYNotable companies reporting before tomorrow's open
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11:29 EDTBMYBristol-Myers January weekly volatility increases into Q4 and outlook
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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.
January 22, 2015
08:49 EDTBMYBristol-Myers price target raised to $70 from $63 at SunTrust
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January 21, 2015
10:16 EDTBMYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 20, 2015
16:34 EDTBMYBristol-Myers appoints Giovanni Caforio CEO
Bristol-Myers Squibb announced a number of leadership changes approved by its board of directors and effective at the close of the annual Shareholders’ Meeting on May. Giovanni Caforio, M.D. will become CEO of the company. Lamberto Andreotti will become executive chairman of the board of directors on May 5 and will continue to serve as chairman after his retirement on August 3. James M. Cornelius, 71, has chosen not to stand for re-election as non-executive chairman and will retire from the board. Togo D. West, Jr., 72, will become the lead independent director on the company’s board.
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 15, 2015
14:31 EDTMYLMylan 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.

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