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News Breaks
February 3, 2014
05:09 EDTMYLMylan launches Hertraz, first trastuzumab biosimilar, in India
Mylan announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched the world's first trastuzumab biosimilar in India. The product, which will be marketed by Mylan under the brand name Hertraz, is a biosimilar to Roche's Herceptin. Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg. According to IPSOS, trastuzumab had sales in India of approximately $21M for the 12 months ended Dec. 31, 2012. Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.
News For MYL From The Last 14 Days
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February 3, 2016
06:13 EDTMYLPfizer insists Allergan deal won't be thwarted by U.S. politicians, FT says
Pfizer (PFE) has insisted that its $160B acquisition of Allergan (AGN) will not be stifled by political opposition, amid criticism that the deal will cost the U.S. Treasury billions of dollars in future tax revenues, the Financial Times reports. Pfizer CEO Ian Read also reiterated his intention to postpone until 2018 a decision on whether to break of the combined entity into two or three smaller companies, but has said that he would be open to offers for its generics unit, the report says. Mylan (MYL) has been connected to a potential acquisition of Pfizer's generic drugs business after it failed in its attempt to buy Perrigo (PRGO) last year, the report says. Reference Link
February 1, 2016
08:04 EDTMYLTeva Mylan not seeing same negative trends as Sandoz, says Bernstein
After Novartis (NVS) reported weak results for its generics unit, Sandoz, and blamed it on industry trends, Bernstein quotes Mylan (MYL) and Teva (TEVA) as saying that they are seeing only "slight adjustments back to normal levels" from "mildly favorable" results in 2014 and 2015. Bernstein says that Sandoz has lost a number of fairly profitable products and has had fewer approvals than its peers. Bernstein keeps Outperform ratings on Teva and Mylan.

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