News For Mylan


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Google 11/21/2018 5:01:41 PM

Mylan taken to task for manufacturing failings at key plant - BioPharma Dive


STAT

Mylan taken to task for manufacturing failings at key plant
BioPharma Dive
The Food and Drug Administration has made official its concerns with Mylan's handling of operations at its largest manufacturing plant, issuing a sharply critical warning letter earlier this month that lays out a series of missteps and oversights at ...
Mylan is scolded by the FDA for manufacturing gaffes at a key plantSTAT
Mylan Recalls Valsartan Lots, Gets FDA Warning for FacilityZacks.com
FDA warns Mylan over Morgantown plantPittsburgh Business Times
In-PharmaTechnologist.com
all 7 news articles »
Google 11/21/2018 4:34:00 PM

Mylan Stock Under Pressure After FDA Letter - Schaeffers Research (blog)


Schaeffers Research (blog)

Mylan Stock Under Pressure After FDA Letter
Schaeffers Research (blog)
The shares of Mylan N.V. (NASDAQ:MYL) are down 0.6% to trade at $33.70 this morning, after the drugmaker disclosed a warning letter from the Food and Drug Administration (FDA) dated Nov. 9, detailing concerns about conditions at a facility in West ...
MYL Stock: Mylan NV (MYL) Is Still Worth a BiteFinancial Mercury
Cantor Fitzgerald Reaffirms Hold Rating for Mylan (MYL)Fairfield Current
Stock alteration:: Mylan NV, (NASDAQ: MYL)StocksNewsPro (press release)
The RNS Daily -Wall Street Morning -Post Analyst -Zacks
all 89 news articles »
Google 11/21/2018 3:15:00 PM

The Daily Biotech Pulse: Mylan Recalls Blood Pressure Drug, Heat Biologics Offering, New Novelion CEO - Benzinga


Benzinga

The Daily Biotech Pulse: Mylan Recalls Blood Pressure Drug, Heat Biologics Offering, New Novelion CEO
Benzinga
Mylan NV (NASDAQ: MYL) announced a nationwide recall of select lots of Valsartan containing products, citing the presence of trace amounts of N-nitrosodiethylamine, an impurity. The recalled products were manufactured by Mylan Pharma and Mylan Labs, ...

Google 11/21/2018 1:04:45 PM

Dr. Reddy's, Mylan Win Challenge To Arthritis Drug Patents - Law360


Dr. Reddy's, Mylan Win Challenge To Arthritis Drug Patents
Law360
Law360 (November 20, 2018, 9:04 PM EST) -- A New Jersey federal judge on Monday invalidated patents covering Horizon Pharma Inc.'s arthritis drug Vimovo in its suit against Dr. Reddy's Laboratories Inc. and Mylan Pharmaceuticals Inc. over their plans ...

Google 11/21/2018 2:04:00 AM

Mylan gets FDA warning letter over infractions at West Virginia plant - Reuters


FiercePharma

Mylan gets FDA warning letter over infractions at West Virginia plant
Reuters
(Reuters) - Mylan NV said on Tuesday it is addressing issues raised in a warning letter it received earlier this month from the U.S. Food and Drug Administration, which flagged concerns regarding the drugmaker's manufacturing plant in West Virginia.
Mylan lower after FDA warningSeeking Alpha
Mylan West Virginia plant tagged with warning letter by FDAFiercePharma
Mylan Statement in Response to FDA Warning Letter Relating to Morgantown PlantPRNewswire (press release)
FDA
all 56 news articles »
Google 11/20/2018 11:29:00 PM

Europe suspends use of Mylan's Hyderabad-made valsartan - In-PharmaTechnologist.com


In-PharmaTechnologist.com

Europe suspends use of Mylan's Hyderabad-made valsartan
In-PharmaTechnologist.com
The detection of N-nitrosodiethylamine (NDEA) in some of Mylan's valsartan batches prompted the decision. NDEA and the related compound N-nitrosodimethylamine (NDMA) are classified by the International Agency for Research on Cancer‚Äč as probable ...
European authorities suspend Mylan's manufacturing license for hypertension drugPittsburgh Business Times

all 4 news articles »
Google 11/20/2018 2:37:35 PM

EU cracks down on blood pressure medicine made by Mylan - Reuters


Reuters

EU cracks down on blood pressure medicine made by Mylan
Reuters
(Reuters) - European Union authorities on Monday stepped in to effectively ban sales of blood pressure medicine valsartan made by an India-based unit of Mylan NV after some batches were found to contain a probable cancer-causing impurity, the latest in ...
EMA Warns of Impurity in Valsartan From MylanRegulatory Focus
European regulators pull Mylan's manufacturing license for valsartan after impurities foundSeeking Alpha
European authorities crack down on blood pressure medicine made by MylanNasdaq
European Medicines Agency - Europa EU
all 27 news articles »
Google 11/19/2018 8:29:20 PM

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