Mylan

848 articles with Mylan

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  FDA Rejects Evolus’ Botox Knockoff for Now

  5/16/2018

  The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Evolus for its Biologics License Application (BLA) for DWP-450 (prabotulinumtoxinA), a drug to treat frown lines similar to Allergan’s Botox.
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  FDA Rejects Perrigo's Generic Version of Teva's ProAir Inhaler

  5/15/2018

  Shares of Perrigo have yet to rebound following the company’s weekend announcement that it expects the U.S. Food and Drug Administration to issue a Complete Response Letter for its generic version of Teva’s ProAir asthma inhaler.

• Mylan Reports First Quarter 2018 Results and Reaffirms 2018 Guidance

  5/9/2018

  Total revenues of $2.68 billion, down 1% compared to the prior year period.

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  The Top 5 Upcoming Biosimilar Approvals in the U.S.

  5/4/2018

  According to Biosimilarpipeline, more than 660 companies worldwide have about 700 biosimilars in development.
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  Scandals Leave a Black Eye on the Pharma Industry

  5/4/2018

  Scandals are nothing new in any industry. The pharmaceutical and biotech industry are certainly no strangers to scandals – just ask convicted scandal-magnet Martin Shkreli.
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  Companies Fight for Growing Share of HIV Market

  5/1/2018

  At the end of 2016, there were an estimated 36.7 million people living with HIV across the globe. With a large and growing patient population, the market for HIV treatments is expected to grow to $22.5 billion by 2025.

• Mylan Adds to Growing Women's Healthcare Portfolio with Launch of Generic for Oral Contraceptive Yaz®

  4/25/2018

  Mylan Pharmaceuticals received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product.

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  The FDA Giveth and Taketh Away: Grants Pfizer's MenB Breakthrough Therapy Designation and Turns D...

  4/23/2018

  The FDA granted Pfizer’s Trumenba, a vaccine for meningococcal B disease in children ages one to nine years, Breakthrough Therapy Designation and declined to approve its biosimilar of Roche's Herceptin for breast cancer.
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  Mylan Rumored to be in Discussions to Buy Merck KGaA’s Consumer Health Business, but Mylan Denies It

  4/13/2018

  Mylan is reportedly in top-level talks with Germany’s Merck KGaA to buy its consumer health business. However, Mylan has denied it.

• Mylan Partners with Fujifilm Kyowa Kirin Biologics to Commercialize Biosimilar to Humira® (adalimumab)

  4/11/2018

  Mylan acquires exclusive license to commercialize in Europe

• Mylan Strengthens Its Capital Structure by Extending Its Debt Maturities with a Successful $1.5 Billion Bond Offering

  4/6/2018

  The Notes will be issued by Mylan Inc. and guaranteed by Mylan N.V., and Mylan intends to use the net proceeds from the offering to redeem $1.5 billion aggregate principal amount of outstanding notes due in 2018 and 2019.

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  Drugs That Are Likely to Fall Off the Patent Cliff This Year

  4/5/2018

  If a brand name drug loses patent protection, that often marks the date when companies can begin marketing generic versions of the drug. However, this has grown more complicated with the approvals of biosimilars.

• Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

  3/28/2018

  Approval complements growing portfolio of cost-saving antiretroviral medications available to patients in the U.S.

• Mylan and Biocon Receive Approvals from the European Commission and TGA Australia for Semglee™, Biosimilar Insulin Glargine

  3/28/2018

  Mylan N.V. and Biocon Ltd. announced that their co-developed biosimilar insulin glargine Semglee™ has received marketing authorization approval from the European Commission (EC).

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  FDA Gives Mylan’s New HIV Drug a Thumbs-Up

  3/28/2018

  The U.S. Food and Drug Administration (FDA) approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients.This marks the third HIV approval for the company.

• Mylan Adds to Growing Oncology Portfolio with Launch of Generic Mutamycin® Injection

  3/20/2018

  Mitomycin for Injection is available to Mylan's hospital and other institutional customers.

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  8 Biotech Companies with Upcoming Catalysts

  3/14/2018

  Here’s a look at eight biopharma companies with upcoming catalysts.
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  Hikma's Advair Generic Gets Further Delayed

  3/12/2018

  Hikma Pharmaceuticals generic version of Advair has hit a stumbling block with the FDA.

• Quotidian Technical Highlights on Selected Generic Drugs Stocks -- Mallinckrodt, Momenta Pharma, Mylan, and Neurocrine Biosciences

  3/5/2018

  WallStEquities.com is offering reports on MNK, MNTA, MYL, and NBIX which can be accessed for free by signing up to www.wallstequities.com/registration.

• Mylan to Introduce Two New Cost-Saving HIV Combination Treatments in the U.S.

  3/2/2018

  Mylan will launch Symfi Lo and Cimduo at a significant discount to the price of competing products to bring cost savings to the $20 billion U.S. ARV market