Mylan

980 articles with Mylan

• Mylan and Development Partner, Synthon, Win Significant European Patent Office Ruling Related to Copaxone® 40mg/mL

  9/15/2020

   Mylan N.V. (NASDAQ: MYL) today announced that the Technical Board of Appeal of the European Patent Office (EPO) has held that Yeda Research and Development Compa

• Mylan and Pfizer Receive European Commission Approval for Proposed Combination of Mylan and Upjohn

  9/15/2020

  The Companies Have Also Received Approvals in Australia and New Zealand; Combination on Track to Close in Fourth Quarter 2020

• Mylan to Acquire Aspen's Thrombosis Business in Europe

  9/8/2020

  Mylan N.V. announced an agreement to acquire the related intellectual property and commercialization rights of Aspen Pharmacare Holdings Limited's thrombosis business in Europe for EUR 641.9 million, subject to customary closing conditions and European regulatory clearances.

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  Mylan Acquires Aspen's European Thrombosis Portfolio for $757.3 Million

  9/8/2020

  The portfolio is made up of well-established injectable coagulants sold in Europe under various brand names, including Arixtra, Fraxiparine, Mon-Embolex and Orgaran.

• Mylan and Biocon Biologics Announce Launch of Semglee™ (insulin glargine injection) in the U.S. to Expand Access for Patients Living with Diabetes

  8/31/2020

  Semglee available in vial and pen presentations at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market

• Mylan Brings Critical Access to the Multiple Sclerosis Community by Launching a More Affordable Treatment Option Through a First Generic to Tecfidera®

  8/19/2020

  Mylan N.V. announced the launch of the first FDA-approved therapeutically equivalent, substitutable generic of Biogen's Tecfidera® capsules.

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  Mylan Wins Approval for First Generic to Biogen's MS Drug Tecfidera

  8/19/2020

  This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.

• Mylan Reports Strong Second Quarter and First Half 2020 Results and Updates 2020 Guidance

  8/6/2020

  Mylan N.V. announced its financial results for the three and six months ended June 30, 2020.

• Mylan to Release Second Quarter 2020 Financial Results on Aug. 6, 2020

  7/22/2020

  Global pharmaceutical company Mylan N.V.  (NASDAQ: MYL) today announced that it will release its second quarter 2020 financial results on Thurs., Aug. 6 , before the open of the U.S. financial markets. The company also will host a webcast at 10:30 a.m. ET on Aug. 6 to discuss the results. The briefing

• Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio® (adalimumab-fkjp)

  7/9/2020

  Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that the U.S. Food and Drug Administration has approved Hulio®, a biosimilar to AbbVie's Humira®, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations.

• Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to the Presence of Particulate

  7/7/2020

  Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited's Specialty Formulation Facility

• Mylan Secures Regulatory Approval for Remdesivir Lyophilized Powder for Injection 100 mg/vial in India for Restricted Emergency Use in COVID-19 Patients

  7/6/2020

  Mylan N.V. announced that the Drug Controller General of India has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI's accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 pandemic.

• Mylan Shareholders Overwhelmingly Approve Proposed Combination with Upjohn

  6/30/2020

  Mylan N.V. (Nasdaq: MYL) today announced that its shareholders overwhelmingly voted to approve the proposed transaction combining Mylan and Upjohn, a division of Pfizer, at the company's extraordinary general meeting of shareholders. 

• Mylan and Lupin Receive European Marketing Authorization for Nepexto®, Biosimilar Etanercept

  6/4/2020

  Mylan N.V.  (NASDAQ: MYL) and Lupin Limited (Lupin) today announced that the European Commission (EC) has granted marketing authorization for Nepexto ® , a biosimilar to Enbrel ® (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic art

• Revance and Mylan to Advance Development Program for Biosimilar to BOTOX®

  6/1/2020

  June 1, 2020 12:30 UTC - First neurotoxin formulation to be developed as a potential biosimilar product to BOTOX ® , potentially giving Mylan access to 14 indications upon approval - - $30 million milestone payable to Revance from Mylan -

• Mylan to Present at the 2020 RBC Capital Markets' Virtual Global Healthcare Conference

  5/13/2020

  Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that Executive Chairman Robert J. Coury and President Rajiv Malik will present at the 2020 RBC Capital Markets' Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 8 a.m. ET.

• Mylan to Supply Investigational Antiviral Remdesivir for the Potential Treatment of COVID-19

  5/12/2020

  Mylan and Gilead Sciences sign global collaboration agreement for the commercialization of remdesivir in 127 low- and middle-income countries

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  Biopharma Update on the Novel Coronavirus: May 12

  5/12/2020

  Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.

• Mylan Releases "A Legacy of Impact: 2019 Global Social Responsibility Report"

  5/4/2020

  Comprehensive report includes a look at Mylan's historical impact on patients, employees, the environment, global public health and the community

• Mylan Board Appoints Robert J. Coury As Executive Chairman of Mylan N.V.

  4/15/2020

   The Mylan N.V. (NASDAQ: MYL) Board of Directors today announced the appointment of Robert J. Coury , previously chairman of the Mylan Board, to the position of executive chairman of Mylan. Given the unprecedented current operating environment due to the COVID-19 pandemic, the extensive ongoing activity