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Survey Highlights Difficulties of Living With Bipolar Disorder
drugs.com
January 13, 2022
Living with and managing bipolar I disorder (BD-I) remains a profoundly challenging experience, according to the results of a survey released by the pharmaceutical..
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New Survey Provides Insights Into Drinking Behaviors During the Pandemic
prnewswire
September 28, 2021
A new online survey conducted during the COVID-19 pandemic by The Harris Poll on behalf of Alkermes, Inc., a subsidiary of Alkermes plc (Nasdaq: ALKS), found that...
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FDA approves Alkermes’ Lybalvi for schizophrenia treatment
pharmaceutical-technology
June 02, 2021
The US Food and Drug Administration (FDA) has approved Alkermes’ Lybalvi as a treatment for adults with schizophrenia and for bipolar I disorder as maintenance monotherapy.
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Alkermes, Merck Enter Clinical Trial and Supply Agreement
contractpharma
April 08, 2021
To evaluate nemvaleukin alfa in combination with Keytruda in patients with platinum-resistant ovarian cancer.
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FDA Advisory Committee Votes in Support of ALKS 3831 for Schizophrenia, Bipolar I
americanpharmaceuticalreview
October 16, 2020
Alkermes announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA).
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FDA Issues Warning Letter to Alkermes
americanpharmaceuticalreview
December 19, 2019
The U.S. Food and Drug Administration (FDA) posted a warning letter to Alkermes of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation ...
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FDA issues warning letter for misrepresentation of drug in advertisement
europeanpharmaceuticalreview
December 16, 2019
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.
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Alkermes Announces Settlement with Amneal over VIVITROL® Patent Dispute
americanpharmaceuticalreview
July 31, 2019
Alkermes has entered into a settlement and license agreement with Amneal Pharmaceuticals to resolve Amneal's inter partes review (IPR) petition challenging U.S. Patent Number 7,919,499 ('499 Patent), an Orange Book-listed patent for ...
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Alkermes Announces Departure of Jim Robinson
firstwordpharma
April 09, 2019
Alkermes plc (Nasdaq: ALKS) announced today that Jim Robinson……
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Alkermes, Biogen Announce FDA Acceptance of Diroximel Fumarate NDA
americanpharmaceuticalreview
February 27, 2019
Alkermes and Biogen announced the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate (BIIB098) .....