MediciNova, Inc., announced that MN-166 (ibudilast) has been approved for “fast track” development by the U.S. Food and Drug Administration (FDA) as a potential treatment for progressive multiple sclerosis (MS). Progressive MS includes both the primary progressive (PPMS) and secondary progressive (SPMS) forms of the disease. MediciNova’s MN-166 was licensed from Kyorin Pharmaceuticals for its potential…
Drug approval
Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo. The FDA designation is…
EMD Serono, the North American biopharmaceutical business arm of Merck, announced it has gained exclusive rights over Rebif (interferon beta-1a) in the United States. Rebif is a treatment for relapsing forms of multiple sclerosis (MS). Rebif, an approved drug, is used to decrease the frequency of MS relapses and delay the occurrence of…
The Multiple Sclerosis Society of New Zealand (MSNZ) announced that PHARMAC has agreed with its request to finance two novel first-in-line therapies for relapsing-remitting forms of multiple sclerosis (MS), making them accessible to patients there. PHARMAC recently agreed to fund the two treatments, teriflunomide (Aubagio), supplied by Sanofi-Aventis NZ, and dimethyl fumarate (Tecfidera),…
Roche recently provided an update on their late-stage pipeline products across several therapeutic areas, including ocrelizumab for the treatment of multiple sclerosis. The data was disclosed on Nov. 5 at the Roche Pharma Day 2015 event in London, U.K. Ocrelizumab was previously revealed to be the first investigational medicine…
PathMaker Neurosystems Inc., a clinical-stage neuromodulation company focused on non-invasive therapies for neuromotor disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted the company’s MyoRegulator™ PM-2200 system the Expedited Access Pathway (EAP) designation and priority processing status. The MyoRegulator is the first product of PathMaker…
Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day, recently announced the approval of a Marketing Authorization license (MA) by the Russian Ministry of Health for three-times-per-week COPAXONE®(glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONE®,…
Osmotica Pharmaceutical Corp. recently announced that the FDA accepted its New Drug Application (NDA) for OntinuaTM ER.
Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions, recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the once per day 20 mg injection of COPAXONE® as prophylaxis for relapses in multiple sclerosis (MS). Glatiramer acetate, the active…
Bayer HealthCare is pleased to announce the US Food and Drug Administration (FDA) has granted the approval of BETACONNECT, a first-of-its-kind electronic autoinjector indicated as a treatment for relapsing-remitting multiple sclerosis (RRMS). For now, the drug delivery device is only compatible with BETASERON® (interferon beta-1b), and will soon be available come early 2016. While…
Merck recently reported its intention to file for European registration of its product candidate for relapsing multiple sclerosis – Cladribine, a synthetic anti-cancer agent able to suppress the immune system. Cladribine causes relatively few side effects and results in very little non-target cell loss. Merck’s decision follows new findings and further characterization of…
Netherlands-based international pharmaceutical company Synthon, best known for developing complex generic therapeutics, has officially entered into an agreement with pharmaceutical giant Pfizer, Inc., effectively transferring the exclusive rights in the US to glatiramer acetate to Pfizer. Glatiramer acetate is an experimental generic formulation of Copaxone, which is indicated as a…
Relapsing remitting multiple sclerosis (RRMS) treatment Plegridy (peg interferon beta-1a) by Biogen Idec, has just received Welsh NHS approval, which should make it available to patients by late October 2015. The decision follows NHS Scotland’s approval earlier this year, however, the biweekly interferon beta shot has yet to be made available in England’s NICE…
Genzyme Canada has announced that Health Canada has approved its 14 mg dose of AUBAGIO as an expedited exception benefit product through the federal health regulator’s Non-Insured Health Benefits (NIHB) Program for eligible First Nations people and Inuit as a first-line oral tablet therapy for relapsing remitting multiple sclerosis (RRMS).
The Canadian Drug Expert Committee (CDEC) recently recommended that LEMTRADA (alemtuzumab) be included in provincial and other public drug plans for the management of adult patients with relapsing-remitting multiple sclerosis (RRMS). The recommendation was made through Canada’s Common Drug Review (CDR) and announced in a press release by the company that…
The U.S. Food and Drug Administration (FDA) has announced it will consider marketing approval of ZINBRYTA (daclizumab high-yield process), a potential treatment for relapsing forms of multiple sclerosis (MS). Biogen and AbbVie, who are jointly developing the therapy, have filed a Biologics License Application…
The Multiple Sclerosis Association of America (MSAA) recently published the latest MS Research Update both printed and online at mymsaa.org. This update is a comprehensive overview of research findings on FDA-approved disease-modifying therapies, as well as many experimental treatments for relapsing forms of…
Bayer HealthCare recently announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a supplemental Biologics License Application (sBLA) for BETACONNECT for the treatment of relapsing-remitting multiple sclerosis (MS). BETACONNECT is a new drug delivery option for patients under Bayer’s BETASERON® (interferon beta-1b) therapy. MS is a…
The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version of Copaxone (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (MS). The administration has granted Sandoz marketing authorization for glatiramer acetate in 20 mg/1 ml…
The Scottish Medicines Consortium has just approved Biogen Idec’s Plegridy (peg interferon beta-1a) for the treatment of relapsing multiple sclerosis (MS) in patients between 18 to 65 years old, making the Consortium the first United Kingdom-based regulatory body to endorse the disease-modifying drug on the…
Takeda Pharmaceutical Company Limited (Takeda) announced late last month its New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the multiple sclerosis relapse prevention drug glatiramer acetate (active ingredient) — which is sold in some markets under the trade name Copaxone. Developed by Israel’s Teva Pharmaceutical Industries…
Ipsen Biopharmaceuticals, Inc announced that the United States Food and Drug Administration (FDA) has agreed to review the supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) to treat upper limb spasticity, a condition that affects many people in the United States, including multiple sclerosis (MS)…
Genzyme, a Sanofi company with over 30 years of dedication to researching and developing novel treatments for rare and orphan diseases, has just announced the Alberta Drug Program has finally decided to include Aubagio® (teriflunomide) 14mg in the provincial drug formulary, indicated for the first-line…
Teva Pharmaceutical Industries Ltd., the company behind multiple sclerosis drug COPAXONE® (glatiramer acetate injection), has been pursuing the US Food and Drug Administration‘s decision against approving a generic version of the drug, by Mylan, Inc. Teva’s petition has been turned down several times,…
Cambridge, Massachusetts based Genzyme announced Friday that the U.S. Food and Drug Administration (FDA) has approved the company’s new drug Lemtrada (alemtuzumab) for treatment of people with relapsing forms of multiple sclerosis, which includes people who experience periodic MS attacks, such as those who have relapsing-remitting MS or secondary-progressive…
Teva Pharmaceutical Industries Ltd., the company that developed the injectable multiple sclerosis treatment Copaxone (Glatiramer acetate), has announced their pursuit of regulatory approval in Japan. This development comes a year after signing an agreement with Takeda Pharmaceutical Co. Ltd. According to a…
A new human clinical trial testing the drug ATL1102 to treat Multiple Sclerosis was approved by FDA, carrying the promise of new therapeutics to affected patients. Antisense Therapeutics Limited (ANP) announced recently in a press release the FDA’s positive decision to approve their request to submit an Investigational…
New Zealand-based Pharmaceutical Management Agency (PHARMAC) has approved the funding of new treatments for multiple sclerosis (MS), which are expected not only to reach more patients, but also be more effective in curtailing the disease’s progressive symptoms. The therapies currently funded are meant for the treatment of …
Now more than ever, groundbreaking, new therapies for chronic diseases and infections come with high price tags. Earlier in the year, Gilead Sciences’ drug Sovaldi for Hepatitis C, as well as Vertex’s Kalydeco for Cystic Fibrosis, both raised eyebrows over their cost. Now, a new MS therapy is doing the…
The U.S. Food and Drug Administration (FDA) accepted the abbreviated new drug application (ANDA) for filing of a Glatiramer Acetate Injection for the treatment of patients with relapsing forms of multiple sclerosis (MS).