Mylan

908 articles with Mylan

• Mylan to Present at the 37th Annual J.P. Morgan Healthcare Conference

  12/20/2018

  Mylan N.V. today announced that CEO Heather Bresch will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, Calif., on Tuesday, Jan. 8, 2019, at 11 a.m. PT / 2 p.m. ET.

• Sanofi's Formulation Patents on Multibillion-Dollar Lantus® are Invalidated by U.S. Patent and Trademark Office via IPR, Announces Mylan

  12/13/2018

  Mylan achieves key milestone to provide U.S. diabetes patients with more affordable generic version of Sanofi's Lantus® insulin glargine vials

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  At Least 16 Generic Drug Companies and 300 Drugs Target of Price-Fixing Investigation

  12/10/2018

  It apparently began with a 2016 federal lawsuit. At that time, 20 state attorneys general filed a federal lawsuit alleging that six generic drug makers artificially inflated and manipulated prices for an antibiotic and an oral diabetes drug. The goal was to reduce competition.

• Mylan Expands its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to All Lots Within Expiry Due to the Detection of Trace Amounts of NDEA

  12/4/2018

  Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry.

• Mylan Expands Gastroenterology Portfolio with Launch of Generic for Prevacid® SoluTab Delayed-Release Orally Disintegrating Tablets

  12/4/2018

  Mylan's Lansoprazole Delayed-Release Orally Disintegrating Tablets are approved to treat certain types of gastrointestinal ulcers

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  Teva Issues Recall of Tainted Blood Pressure Medicine, the Latest Global Recall for Valsartan

  11/28/2018

  There has been another recall for blood pressure medications. This time Teva Pharmaceutical has issued a voluntary recall for combination forms of its blood pressure drug Amlodipine due to cancer-causing impurities discovered in the tablets.

• Mylan to Present at Nasdaq's 39th London Investor Conference

  11/26/2018

  Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will present at Nasdaq's 39th London Investor Conference on Tuesday, Dec. 4, 2018, at 9:45 a.m. GMT/4:45 a.m. ET

• Mylan Statement in Response to FDA Warning Letter Relating to Morgantown Plant

  11/20/2018

  Mylan N.V. today commented on a Warning Letter issued by the U.S. Food and Drug Administration (FDA) on Nov. 9, 2018, relating to its manufacturing facility in Morgantown, West Virginia.

• Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine)

  11/20/2018

  Mylan N.V. today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength.

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  Drug Approvals for the 2 Most Common Types of Cancer in the Last 2 Years

  11/19/2018

  According to the American Cancer Society, almost 601,000 people in the U.S. died of cancer in 2017. The two most common types of cancer are lung cancer and breast cancer, followed by colorectal cancer, prostate cancer and stomach cancer. 
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  FDA Action Alert: Theravance's Approval, Mallinckrodt and Aquestive

  11/12/2018

  The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.

• Theravance Biopharma and Mylan Receive FDA Approval for YUPELRITM (revefenacin) in Adults with Chronic Obstructive Pulmonary Disease

  11/9/2018

  YUPELRI (revefenacin) is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US

• Theravance Biopharma and Mylan Receive FDA Approval for YUPELRI™ (revefenacin) in Adults with Chronic Obstructive Pulmonary Disease

  11/9/2018

  YUPELRI (revefenacin) is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US

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  Allergan Backs off From $200 Million Plant Expansion in Waco, Texas

  11/6/2018

  Allergan indicated that it “has shifted [its] priority from expanding the Waco site to investing significantly in our existing operations.” However, the company spokesperson said that Allergan “remains committed to our eye care business and operations in Waco.”

• Mylan Reports Third Quarter 2018 Results and Reaffirms 2018 Guidance

  11/5/2018

   Mylan N.V. (NASDAQ: MYL) today announced its financial results for the quarter and nine months ended September 30, 2018.

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  Early November Brings More Quarterly Reports

  11/2/2018

  Biopharma companies set to release financial reports next week have reported positive news in recent months.
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  FDA Approves Humira Biosimilar That Won’t Be Available Until 2023

  11/1/2018

  The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.

• Mylan and Biocon Announce Positive CHMP Opinion for Ogivri®, Biosimilar Trastuzumab

  10/19/2018

  Mylan N.V. and Biocon Ltd. today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri®, a biosimilar to Roche's Herceptin® (trastuzumab).

• Mylan Launches Hulio™ (Biosimilar Adalimumab) in Markets Across Europe

  10/19/2018

  Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it has initiated the commercial launch of Hulio™, a biosimilar to AbbVie's Humira® (adalimumab), across major markets in Europe.

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  FDA Proposes Steps to Standardize Generic Drugs Globally

  10/19/2018

  Part of the Trump Administration and the U.S. Food and Drug Administration (FDA)’s strategy to push down drug prices is to develop ways to increase competition. As such, the agency launched a Drug Competition Action Plan that has several components.