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Enforcement Report - Week of July 26, 2023
26 Jul 2023 //
FDA
US Supreme Court rebuffs Novartis bid to revive MS drug Gilenya patent
18 Apr 2023 //
REUTERS
Vyne swings behind BET, seeks partner for failed eczema drug
10 Mar 2023 //
FIERCE BIOTECH
Drug, TASCENSO ODT , Launched to Meet the Needs of Multiple Sclerosis Patients
13 Feb 2023 //
BUSINESSWIRE
Novartis takes Gilenya patent case to Supreme Court
25 Jan 2023 //
FIERCE PHARMA
Supreme Court rejects Novartis` request for stay in Gilenya patent battle
15 Oct 2022 //
ENDPTS
U.S. Supreme Court rebuffs Novartis, allows generic versions of MS drug
13 Oct 2022 //
REUTERS
Bionpharma`s Generic Fingolimod Hydrochloride Receives Approval in the U.S.
06 Oct 2022 //
FDA
Novartis takes Gilenya fight to Supreme Court as generic competition looms
22 Sep 2022 //
ENDPTS
Novartis plans to petition the U.S. Supreme Court to uphold of the Gilenya
20 Sep 2022 //
GLOBENEWSWIRE
Prinston`s Generic Fingolimod HCL Receives Approval in the U.S.
07 Sep 2022 //
FDA
Mylan Generic Fingolimod HCL Receives Tentative Approval in the U.S.
15 Jul 2022 //
FDA
New MAVENCLAD Data at ACTRIMS Forum 2022 Show Favourable Efficacy Outcomes
24 Feb 2022 //
BUSINESSWIRE
Novartis beats appeal over MS drug patent, keeping generic at bay
04 Jan 2022 //
PRESS RELEASE
HEC Pharm Group`s Generic Fingolimod Hydrochloride Receives Approval In US
16 Nov 2021 //
FDA
Teva Pharms USA`s Generic Fingolimod Hydrochloride Receives Approval In US
16 Nov 2021 //
FDA
Mylan`s Fingolimod Mylan (fingolimod)Receives Approval in Europe
31 Aug 2021 //
EMA
Mylan`s Fingolimod Mylan (fingolimod) Receives Approval in Europe
18 Aug 2021 //
EMA
Apotex`s Generic Fingolimod Hydrochloride Receives Approval in US
22 Dec 2020 //
FDA
Gilenya (fingolimod) - Important Safety Information from Novartis Ireland
13 Nov 2020 //
FIRSTWORDPHARMA
Zydus Cadila receives US FDA approval to market fingolimod capsules
15 Oct 2020 //
PHARMABIZ
High sero prevalence in cities indicate India`s IFR might be low, despite doubts
18 Aug 2020 //
THEECONOMICTIMES
U.S. court upholds patent for Novartis MS drug Gilenya
18 Aug 2020 //
REUTERS
Novartis announces US District Court for the District of Delaware of Gilenya®
17 Aug 2020 //
NOVARTIS
MS drug may be used to inhibit HIV infection and reduce latent reservoir
14 Aug 2020 //
SCIENCEDAILY
Teva Pharms Generic Fingolimod Hydrochloride Receives Approval in US
08 Jul 2020 //
FDA
Strides Pharma`s Generic Fingolimod Hydrochloride Receives Approval in U.S
30 Jun 2020 //
FDA
Glenmark Pharm`s Generic Fingolimod Hydrochloride Receives Approval In Us
26 Jun 2020 //
FDA
MSN Labs Generic Fingolimod Receives Tentative Approval In US
23 May 2020 //
FDA
Hetero Lab V`s Generic Fingolimod Hydrochloride Receives Approval in US
22 May 2020 //
FDA
Novartis on the hook in retaliatory firing case, judge rules
18 Apr 2020 //
FIERCEPHARMA
Bionpharma`s Generic Fingolimod Receives Tentative Approval in US
09 Apr 2020 //
FDA
Novartis escapes one set of kickback allegations, but federal charges roll on
26 Mar 2020 //
FIERCE PHARMA
HEC Pharm`s Generic Fingolimod Hydrochloride Receives Approval In Us
11 Dec 2019 //
FDA
Biocon`s Generic Fingolimod Hydrochloride Receives Approval In Us
11 Dec 2019 //
FDA
Sun Pharma`s Generic Fingolimod Hydrochloride Receives Approval in US
11 Dec 2019 //
FDA
FDA greenlights generics of Novartis` $3B MS star Gilenya amid legal fight
07 Dec 2019 //
FIERCE PHARMA
FDA approves first generics of Gilenya
05 Dec 2019 //
PR NEWSWIRE
J&J`s head-to-head PhIII data promise drug launch into crowded MS market
13 Sep 2019 //
ENDPOINTSNEWS
Novartis reports positive Phase III data for multiple sclerosis drug
03 Sep 2019 //
CLINICALTRIALSARENA
Novartis` repurposed cancer drug Arzerra outpaces Sanofi`s Aubagio in MS trial
31 Aug 2019 //
FIERCE PHARMA
Multiple sclerosis drug costs skyrocketed for Medicare and patients, study finds
27 Aug 2019 //
BIOPHARMADIVE
EMA alerts women not to use MS medicine, Gilenya during pregnancy
29 Jul 2019 //
PHARMABIZ
Updated restrictions for Gilenya: MS medicine not to be used in pregnancy
26 Jul 2019 //
EMA
Still strong a decade on, Gilenya gains approval in China
19 Jul 2019 //
THE PHARMALETTER
LifeMax gains rare pediatric status for Netherton syndrome candidate LM-030
19 Jul 2019 //
THE PHARMALETTER
WHO keeps key lung cancer drugs off its essential medicines list
10 Jul 2019 //
REUTERS
Gilead Announces Intent To Submit NDA For Filgotinib
01 Jul 2019 //
GLOBE NEWSWIRE
Novartis Gilenya staves off geric challengers? - for now.
26 Jun 2019 //
FIERCE PHARMA
Cost-effectiveness watchdogs skewer J&J`s depression spray Spravato
22 Jun 2019 //
FIERCE PHARMA
Novartis presents positive data from ASSESS study of Gilenya
11 May 2019 //
PHARMABIZ
Merck KGaA finally chalks up FDA nod for MS med Mavenclad
02 Apr 2019 //
FIERCE PHARMA
Celgene`s MS drug ozanimod gets EU filing
12 Mar 2019 //
FIERCE BIOTECH
Aurobindo Pharma`s Generic Fingolimod Receives Tentative Approval in US
07 Feb 2019 //
FDA
Novartis` Gilenya scores paediatric EU approval for advanced r/r MS
29 Nov 2018 //
PHARMA FILE
FDA warns about worsening of MS after stopping Gilenya (fingolimod)
20 Nov 2018 //
FDA
Novartis` Gilenya tops Teva giant Copaxone in head-to-head MS study
11 Oct 2018 //
FIERCE PHARMA
