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Mylan and Biocon Herceptin biosimilar delayed by FDA for 3 months
fiercepharma
September 05, 2017
Mylan and Biocon, which have had trouble getting to the regulatory finish line in Europe with their biosimilar of Roche’s blockbuster Herceptin because of manufacturing concerns, now face a three-month delay in the U.S.
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Otsuka, Mylan to Commercialize Delamanid
americanpharmaceuticalreview
August 25, 2017
Otsuka Pharmaceutical and Mylan have entered into a license agreement between their subsidiaries to commercialize delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries
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Mylan Agrees to Pay $465 Million for Underpaying EpiPen Rebates
americanpharmaceuticalreview
August 21, 2017
Mylan Inc. and Mylan Specialty L.P. have agreed to pay $465 million to resolve claims that they violated the False Claims Act by knowingly misclassifying EpiPen as a generic drug to avoid paying rebates owed primarily to Medicaid, the Justice Department a
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Sanofi tip ends in $465M settlement between Mylan and DOJ
fiercepharma
August 18, 2017
Mylan announced it finalized a $465 million settlement relating to EpiPen's misclassification on Medicaid.
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Mylan launches MyHep All in India
pharmaasia
August 18, 2017
Mylan Pharmaceuticals Private Limited (a subsidiary of Mylan N.V.) has announced the launch of Velpatasvir 100 mg/Sofosbuvir 400mg tablets under the brand name MyHep All in India.
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Mylan launches three generic anti-retroviral treatments for HIV patients in Canada
pharmaceutical-technology
August 15, 2017
US-based Mylan's Canadian subsidiary Mylan Pharmaceuticals has launched three generic anti-retroviral (ARV) medicines for the treatment of HIV for certain patients in Canada.The company has received final approval from Health Canada for the three products
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Kaléo, maker of EpiPen rival Auvi-Q, teams up on peanut-free baseball games
fiercepharma
August 14, 2017
The Salt Lake Bees hosted one of the first Auvi-Q co-sponsored peanut-free MiLB games.
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Feds pull Mylan, a small-time opioid drugmaker, into industrywide marketing probe
fiercepharma
August 11, 2017
The Department of Justice subpoenaed Mylan in July for information relating to its opioid business. At least two other drugmakers have disclosed similar demands this month.
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Mylan Launches Three Generic Antiretroviral Medicines in Canada
americanpharmaceuticalreview
August 11, 2017
Mylan Pharmaceuticals announced the launch in Canada of three generic products indicated in the treatment of HIV for certain patients. One of the products is Mylan-Emtricitabine/Tenofovir Disoproxil Fumarate 200 mg/300 mg, a generic alternative to Truvada
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Mylan points finger at FDA for failure to win nods on Advair, Copaxone copies
fiercepharma
August 10, 2017
Mylan's sales and profits each missed forecasts for Q2