Optimal Dose of Fingolimod for Multiple Sclerosis Confirmed Optimal Dose of Fingolimod for Multiple Sclerosis Confirmed
The 0.5-mg dose of fingolimod provides a greater reduction in annualized relapse rate vs both the 0.25-mg dose of fingolimod and the 20-mg dose of glatiramer acetate.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - September 17, 2020 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news

Multiple Sclerosis Drug Shows Promise For HIV Prevention And Treatment
Researchers at The George Washington University in D.C. and their colleagues found that a drug called Fingolimod, that is approved for multiple sclerosis treatment, also blocks HIV transmission and infection in human cells. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - August 13, 2020 Category: Pharmaceuticals Authors: Anuradha Varanasi, Contributor Tags: Healthcare /healthcare Innovation /innovation Source Type: news

Multiple sclerosis drug blocks HIV infection and transmission in human immune cells
(PLOS) An immunomodulatory drug called fingolimod, which is approved for the treatment of multiple sclerosis, blocks human immunodeficiency virus (HIV) infection and transmission in human immune cells, according to a study published August 13 in the open-access journal PLOS Pathogens by Postdoctoral Fellow Rachel Resop and Assistant Professor Alberto Bosque of The George Washington University, and colleagues. These preliminary findings suggest that this compound may be a promising novel therapy for HIV treatment and prevention. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - August 13, 2020 Category: Infectious Diseases Source Type: news

Glenmark Pharmaceuticals gets USFDA nod for Fingolimod capsules
"Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation," the drug major said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 19, 2020 Category: Pharmaceuticals Source Type: news

Natalizumab Bests Fingolimod for Relapsing-Remitting MS Natalizumab Bests Fingolimod for Relapsing-Remitting MS
In a head-to-head comparison, natalizumab was superior to fingolimod for evidence of disease activity at 1 year for patients with active relapsing-remitting multiple sclerosis.Medscape Medical News (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - May 13, 2020 Category: Allergy & Immunology Tags: Neurology & Neurosurgery News Source Type: news

EMA Panel Backs Generic for MS Drug Fingolimod (Gilenya) EMA Panel Backs Generic for MS Drug Fingolimod (Gilenya)
Studies have demonstrated bioequivalence of Fingolimod Accord to the reference product Gilenya for relapsing forms of multiple sclerosis, the EMA said.News Alerts (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - May 2, 2020 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news

FDA Okays First Generics for MS Drug Fingolimod (Gilenya) FDA Okays First Generics for MS Drug Fingolimod (Gilenya)
The FDA granted three companies approval to market generic copies of fingolimod (Gilenya), the first oral disease-modifying multiple sclerosis therapy approved in 2010.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 6, 2019 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

FDA approves first generics of Novartis blockbuster MS drug
The U.S. FDA has approved three applications for first generics of Gilenya capsules for the treatment of relapsing forms of multiple sclerosis in adults. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 6, 2019 Category: Pharmaceuticals Source Type: news

FDA Approves First Generic Forms of MS Drug Gilenya
FRIDAY, Dec. 6, 2019 -- The first generic versions of the multiple sclerosis drug Gilenya have been approved by the U.S. Food and Drug Administration. The three generic versions of Gilenya (fingolimod) capsules were approved for the treatment of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 6, 2019 Category: General Medicine Source Type: news

FDA Approves First Generics of Gilenya
December 05, 2019 -- The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.“Approving safe... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 5, 2019 Category: Pharmaceuticals Source Type: news

U.S. FDA approves generic versions of Novartis blockbuster MS treatment
The U.S. Food and Drug Administration on Thursday approved three generic versions of Swiss drugmaker Novartis AG's top-selling multiple sclerosis (MS) medicine Gilenya. (Source: Reuters: Health)
Source: Reuters: Health - December 5, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves first generics of Gilenya
The U.S. Food and Drug Administration today approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 5, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves first generics of Gilenya
The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. (Source: World Pharma News)
Source: World Pharma News - December 5, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

Different Infection Risks for MS Treatments Different Infection Risks for MS Treatments
New study results suggest rituximab has a higher risk of serious infections than fingolimod or natalizumab, but a lower risk of herpetic infections.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - October 11, 2019 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news

Novartis's older MS drug Gilenya wins Chinese approval
Novartis's Gilenya multiple sclerosis drug has won approval in China, the Swiss drugmaker said on Friday, as the company expands further into the world's most-populous country's growing healthcare sector. (Source: Reuters: Health)
Source: Reuters: Health - July 19, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Novartis wins Gilenya reprieve as judge blocks generics, for now
Novartis has won a U.S. federal court order preventing rival generic makers from selling versions of the Swiss drugmaker's top-selling multiple sclerosis medicine Gilenya in the United States, at least until a patent dispute is resolved. (Source: Reuters: Health)
Source: Reuters: Health - June 25, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Novartis wins Gilenya reprieve as judge blocks generics, for now
The judge said letting generics makers sell their versions before the patent dispute was decided would damage the Swiss drugmaker more than those wanting a piece of Gilenya's market. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 25, 2019 Category: Pharmaceuticals Source Type: news

FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs
[07-04-2015] The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 19, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Diving into the details: A lipid-binding pocket is a target for new cancer therapies
(Medical University of South Carolina) Cell growth is tightly controlled; however, cancer cells overcome the normal growth controls and proliferate uncontrollably. Researchers at the Medical University of South Carolina examined the molecular details underlying the interaction of ceramide, a lipid that plays a critical role in several signaling pathways, with a protein complex involved in modulating cell growth. They showed that ceramide and a similar compound, fingolimod, disrupt the interaction of SET with PP2A to repress cell growth. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - April 29, 2019 Category: Cancer & Oncology Source Type: news

Two Updates in Multiple Sclerosis Two Updates in Multiple Sclerosis
Dr Stephen Krieger on when anti-MOG antibody testing is warranted, and how to properly manage the risk for post-fingolimod rebound.Medscape Neurology (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - April 26, 2019 Category: Radiology Tags: Neurology & Neurosurgery Commentary Source Type: news

Risk for Conversion of MS Varies With Different Therapies
WEDNESDAY, Jan. 16, 2019 -- For relapsing-remitting multiple sclerosis (MS), the risk for conversion to secondary progressive MS is lower with initial treatment with fingolimod, alemtuzumab, or natalizumab versus glatiramer acetate or interferon... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 16, 2019 Category: Pharmaceuticals Source Type: news

IDIBELL researchers identify a new leukodystrophy in children and its potential cure
(IDIBELL-Bellvitge Biomedical Research Institute) The Neurometabolic Diseases research team at IDIBELL and CIBERER, led by Aurora Pujol, has uncovered a novel disease of children affecting the brain white matter -- the myelin sheath --, leading to severe incapacity and death in some cases. These defects were corrected by a treatment with fingolimod, a drug in use for multiple sclerosis which interferes with this pathway. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 10, 2019 Category: International Medicine & Public Health Source Type: news

FDA: Stopping Fingolimod May Exacerbate MS
(MedPage Today) -- Rare effects including severely increased disability, multiple new lesions (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - November 21, 2018 Category: American Health Source Type: news

FDA Warns of MS Worsening After Stopping Fingolimod (Gilenya) FDA Warns of MS Worsening After Stopping Fingolimod (Gilenya)
The agency adds a new warning to the fingolimod label and patient medication guide about this risk, which can lead to permanent disability.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 21, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news

FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 20, 2018 Category: Drugs & Pharmacology Source Type: news

Switching to Alemtuzumab in MS, Keep Washout to a Minimum Switching to Alemtuzumab in MS, Keep Washout to a Minimum
Two new studies of patients switching from natalizumab or fingolimod to alemtuzumab suggest that shorter washout periods are better to reduce disease reactivation.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 24, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Natalizumab or Fingolimod After First-Line Drugs in MS? Natalizumab or Fingolimod After First-Line Drugs in MS?
A new propensity score analysis suggests natalizumab may have the edge over fingolimod for patients who experience relapse on first-line drugs, especially patients with more active disease.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 11, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

PARADIGMS: Fingolimod Effective, Well Tolerated in Children PARADIGMS: Fingolimod Effective, Well Tolerated in Children
Results show an 82% reduced annualized relapse rate among pediatric patients with multiple sclerosis taking fingolimod compared with those taking interferon-beta1a.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 14, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Fingolimod Cuts Multiple Sclerosis Relapses in Pediatric Patients
WEDNESDAY, Sept. 12, 2018 -- Among pediatric patients with relapsing multiple sclerosis, fingolimod is associated with a lower rate of relapse but a higher rate of serious adverse events than interferon beta-1a, according to a study published in the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 12, 2018 Category: Pharmaceuticals Source Type: news

New Drug Fingolimod (Gilenya) Could Help Kids With MS
WEDNESDAY, Sept. 12, 2018 -- Researchers say the first drug for children with multiple sclerosis vastly outperformed another common MS medication in a new clinical trial. Fingolimod (Gilenya) reduced relapse rates by 82 percent in patients aged 10... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - September 12, 2018 Category: General Medicine Source Type: news

Natalizumab cost effective versus fingolimod for RRMS
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - June 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Expands Use of MS Drug to Include Children
MONDAY, May 14, 2018 -- The U.S. Food and Drug Administration has expanded its approval of the multiple sclerosis drug Gilenya (fingolimod) to include children aged 10 and older. It's the first multiple sclerosis drug approved for children, the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 14, 2018 Category: Pharmaceuticals Source Type: news

Use of MS Drug, Gilenya (Fingolimod), Expanded to Include Children
MONDAY, May 14, 2018 -- The U.S. Food and Drug Administration has expanded its approval of the multiple sclerosis drug Gilenya (fingolimod) to include children aged 10 and older. It's the first multiple sclerosis drug approved for children, the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - May 14, 2018 Category: General Medicine Source Type: news

FDA Okays Fingolimod (Gilenya), First Treatment for Pediatric MS FDA Okays Fingolimod (Gilenya), First Treatment for Pediatric MS
The FDA has expanded approval of the oral agent fingolimod from treatment for adults to treatment for children and adolescents aged 10 and up with multiple sclerosis.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 12, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news

FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients
May 11, 2018 -- The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 12, 2018 Category: Drugs & Pharmacology Source Type: news

Fingolimod OK'd for Pediatric MS
(MedPage Today) -- First drug approved for multiple sclerosis in kids 10 and older (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - May 11, 2018 Category: American Health Source Type: news

FDA expands use of Novartis MS drug to pediatric patients
(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday expanded the use of Novartis AG's relapsing multiple sclerosis (MS) drug Gilenya to treat children and adolescents. (Source: Reuters: Health)
Source: Reuters: Health - May 11, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 11, 2018 Category: American Health Source Type: news

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients. (Source: World Pharma News)
Source: World Pharma News - May 11, 2018 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

La FDA advierte sobre casos de una infecci ó n cerebral infrecuente con el medicamento para la esclerosis m ú ltiple (EM) Gilenya (fingolimod) en dos pacientes que no hab í an tenido previamente exposici ó n a medicamentos inmunodepresores
[08-04-2015] La Administraci ó n de Alimentos y Medicamentos (FDA) de los Estados Unidos advierte sobre el reporte de un caso de leucoencefalopat í a multifocal progresiva (LPM) definitiva y de un caso de probable LPM en pacientes que tomaban Gilenya (fingolimod) por la esclerosis m ú ltiple (EM). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre casos de una infecci ón cerebral infrecuente con el medicamento para la esclerosis múltiple (EM) Gilenya (fingolimod) en dos pacientes que no habían tenido previamente exposición a medicamentos inmunodepresores
[08-04-2015] La Administraci ón de Alimentos y Medicamentos (FDA) de los Estados Unidos advierte sobre el reporte de un caso de leucoencefalopatía multifocal progresiva (LPM) definitiva y de un caso de probable LPM en pacientes que tomaban Gilenya (fingolimod) por la esclerosis múltiple (EM). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs
[07-04-2015] The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Rituximab Outperforms Other Drugs in RRMS Rituximab Outperforms Other Drugs in RRMS
In a new study, rituximab was superior to other drugs -- including fingolimod, natalizumab, and dimethyl fumarate -- in efficacy, safety, and tolerability in patients with relapsing-remitting MS.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 11, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Gilenya (Fingolimod Capsules) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 2, 2018 Category: Drugs & Pharmacology Source Type: news

Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
Breakthrough Therapy designation can expedite the development and review of therapies for serious conditions(1) In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82% in a pediatric patient population vs. interferon beta-1a ... Biopharmaceuticals, Neurology, FDA Novartis, Gilenya, Fingolimod, multiple sclerosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 18, 2017 Category: Pharmaceuticals Source Type: news

New daily tablet offers hope to MS youngsters
Experts have hailed the results of a trial of the drug Gilenya as ‘some of the most promising ever seen’ following a study of 215 children aged between ten and 17 from across the globe. (Source: the Mail online | Health)
Source: the Mail online | Health - November 11, 2017 Category: Consumer Health News Source Type: news

Impressive Results With Fingolimod in Pediatric MS Impressive Results With Fingolimod in Pediatric MS
In the first randomized trial in pediatric multiple sclerosis, fingolimod was associated with sizable reductions in relapse rate, new MRI lesions, brain atrophy, and disability progression compared with interferon beta.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 1, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Oral Drug Beats Interferon in First Pediatric MS Trial
(MedPage Today) -- Fingolimod cut relapses, brain shrinkage but with more adverse events (Source: MedPage Today Meeting Coverage)
Source: MedPage Today Meeting Coverage - October 29, 2017 Category: General Medicine Source Type: news

Cardiac Effects of Fingolimod in MS Reversible Cardiac Effects of Fingolimod in MS Reversible
Fingolimod, used to treat multiple sclerosis, dampens cardiac autonomic modulation at rest and during challenges, but this effect appears to be reversible after discontinuation of the drug, a study shows.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 25, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Pharma ’s social contract: time for everyone to join in
When a scandal occurs in pharma, the whole industry is tarred by the same brush. We ’re still suffering the ill effects of Martin Shkreli’s 5000%overnight price increase of a life-saving anti-parastic, from way back in 2015.Pharma ’s trust problemBrent Saunders, Chairman& CEO of Allergan,sees this as part and parcel of doing business in this industry. Pricing will always be controversial within healthcare, because choosing between two sets of health outcomes is fundamentally different from choosing between two different brands of an electric toaster. The problem is: this reality isn ’t wide...
Source: EyeForPharma - September 6, 2017 Category: Pharmaceuticals Authors: Paul Simms Source Type: news