Mylan

880 articles with Mylan

• Mylan Extends Commitment to Fight HIV/AIDS by Partnering with Atomo Diagnostics to Expand Access to HIV Self-Testing in Low- and Middle-Income Countries

  9/24/2018

  Mylan N.V. and medical device company Atomo Diagnostics today announced a strategic partnership to commercialize CE-Marked in vitro HIV rapid diagnostic tests for self-testing in low- and middle-income countries.

• Mylan and Fujifilm Kyowa Kirin Biologics Receive European Marketing Authorization for Hulio®, Biosimilar Adalimumab

  9/20/2018

  Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for Hulio® (Product Code: FKB327), a biosimilar to AbbVie's Humira® (adalimumab), for all indications.

• Theravance Biopharma and Mylan Report New Data from Phase 3 Studies of YUPELRI™ (revefenacin) in Oral Presentation at the European Respiratory Society International Congress

  9/17/2018

  Reduction in Rates of COPD Exacerbations Observed in COPD Patients Treated with YUPELRITM Compared to Placebo and Tiotropium (Spiriva® HandiHaler®)

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  Acorda Therapeutics Has One Bad Week With Loss of Patents and Delayed FDA Review

  9/14/2018

  Acorda Therapeutics’ week started off badly and has only gotten worse. It started off with the loss of an appeal for some of its Ampyra patents and has ended with the U.S. FDA's decision to delay a ruling for its Parkinson’s disease treatment.
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  Patent Litigation Updates: CRISPR, Acorda’s Ampyra, and Orexo Versus Teva

  9/11/2018

  Although the dominant story in biopharma patent litigation was the federal appeals court backing the Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard University over the University of California (UC) on CRISPR patents, there have been other patent decisions of note t...
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  Mylan Strikes $463 Million Deal With Novartis for CF Product Line

  9/7/2018

  Mylan plunked down $463 million for Novartis’ cystic fibrosis products, which includes the TOBI Podhaler and TOBI solution.
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  Updated: Merck Scores FDA Approval for Two New HIV Treatments

  8/31/2018

  Nearly two months ahead of the planned PDUFA date, the U.S. Food and Drug Administration approved two new HIV-1 treatments developed by Merck. The FDA gave the go ahead for Delstrigo, a once-per day triple combination treatment and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor.
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  Teva Snags FDA Approval for Generic EpiPen

  8/17/2018

  Shares of Teva Pharmaceuticals jumped more than 7 percent in afternoon trading Thursday and continue to rise in premarket trading this morning after the U.S. Food and Drug Administration approved the company’s generic version of the EpiPen Auto-Injector.

• Mylan Launches First Generic for Adcirca® Tablets

  8/13/2018

  Global pharmaceutical company Mylan today announced the U.S. launch of Tadalafil Tablets USP, 20 mg, the first generic version of the reference listed drug, Eli Lilly and Company's Adcirca®.

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  A Deep Dive into Teva Pharma Financials Shows Significant Weakness and Optimism

  8/9/2018

  Last week, Teva Pharmaceutical released what tried to be an optimistic second-quarter financial report, despite revenues that had decreased by 18 percent and softening sales of its biggest product, Copaxone.

• Statement from Mylan's Board of Directors

  8/8/2018

  Global pharmaceutical company Mylan N.V.'sboard of directors today released the following statement

• Mylan Reports Second Quarter 2018 Results and Updates 2018 Guidance

  8/8/2018

  Mylan N.V. announced its financial results for the quarter and six months ended June 30, 2018.

• Mylan and Fujifilm Kyowa Kirin Biologics Announce Positive CHMP Opinion for Hulio™, Biosimilar Adalimumab

  7/27/2018

  Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of HulioTM (Product Code: FKB327), the companies' biosimilar to Humira® (adalimumab), for all indications.

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  Allergan’s Good News Doesn’t Quite Outweigh the Bad

  7/23/2018

  Despite positive Phase III clinical trial data for Allergan’s age-related macular degeneration drug, investors weren’t as positive about it.

• Mylan Again Defeats Allergan's Efforts to Deny Patients Access to More Affordable Medicine

  7/20/2018

  Global Pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent Trial and Appeal Board (PTAB), which found that tribal sovereign immunity cannot apply to prevent inter partes review (IPR) proceedings.

• AbbVie Announces HUMIRA® (adalimumab) Patent License with Mylan

  7/17/2018

  AbbVie announced patent license agreements with Mylan over its proposed biosimilar adalimumab product.

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  AbbVie Strikes Deal With Mylan to Delay Humira Biosimilar Challenge

  7/17/2018

  AbbVie continues to do what it can to protect its Humira-driven revenue stream. This morning the company inked an agreement to grant Mylan the rights to begin marketing its biosimilar to Humira in the United States in 2023.
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  June was a Busy Month for the FDA, Which Approved 7 Novel Drug Approvals

  7/16/2018

  The U.S. Food and Drug Administration (FDA) was busy during the first half of this year with more than 20 novel drug approvals. Of those approvals, one-third came in June.

• Mylan Adds to Central Nervous System Portfolio With Launch of Generic Exelon® Patch

  7/9/2018

  Mylan N.V. today announced the U.S. launch of Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, a generic version of Novartis' Exelon® Patch.

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  FDA Withdraws Draft Guidance on Biosimilar Development

  7/3/2018

  The U.S. Food and Drug Administration withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.