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US FDA approves Novartis Kesimpta (ofatumumab) for relapsing forms of MS treatment
expresspharma
August 24, 2020
Ofatumumab was first approved by the FDA in 2009 for the treatment of chronic lymphocytic leukaemia (CLL).
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Mylan announces launch of generic version of Biogen’s Tecfidera
expresspharma
August 20, 2020
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS).
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Mylan Wins District Court Decision against Biogen's Tecfidera Patent
americanpharmaceuticalreview
June 30, 2020
Mylan announced the U.S. District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera® patent, U.S. Patent No. 8,399,514, for lack of written description.
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NICE does not recommend Novartis’ siponimod for secondary progressive MS
europeanpharmaceuticalreview
June 30, 2020
NICE has decided to not recommend Mayzent (siponimod) for use on the NHS as a secondary progressive multiple sclerosis treatment because its clinical trial did not directly compare it to interferon beta-1b.
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NICE rejects Novartis' Mayzent for secondary progressive MS
pharmatimes
June 29, 2020
NICE has turned down NHS funding in preliminary guidelines for use of Novatis' Mayzent (siponimod) as a treatment for secondary progressive multiple sclerosis (SPMS) with evidence of active disease.
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Regulators expand review time for Novartis' MS drug
pharmatimes
June 05, 2020
US regulators are extending the review time for Novartis' MS therapy ofatumumab.
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Biogen launches digital self-help tool to support mental health in MS
pharmatimes
June 05, 2020
Biogen has announced the UK launch of a new digital self-help tool to support the mental health of people with multiple sclerosis.
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Janssen seeks FDA approval for ponesimod in MS
pharmaceutical-technology
March 20, 2020
Janssen Pharmaceutical has filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for ponesimod to treat relapsing multiple sclerosis (MS) in adults.
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Setback for MedDay’s MD1003 as drug fails non-active progressive MS trial
pharmatimes
March 13, 2020
MedDay Pharmaceuticals has announced new top-line data showing that its experimental drug MD1003 missed the primary and secondary endpoints of the Phase III SPI2 trial.
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GW Pharma regains Sativex rights in UK
pharmatimes
March 06, 2020
GW Pharmaceuticals has regained the rights to the commercialisation of Sativex (nabiximols) in the UK, taking the reins back from Bayer.