July 2, 2020 News by Joana Carvalho, PhD Osmotica Amends NDA for Arbaclofen ER to Treat MS Spasticity Osmotica Pharmaceuticals has submitted an amended new drug application (NDA) to the U.S. Food and Drug Administration (FDA) requesting the approval of arbaclofen extended release (ER) tablets for the treatment of spasticityĀ in people with multiple sclerosis (MS). Arbaclofen ER (brand name…
June 4, 2020 News by Marisa Wexler, MS FDA Extends Review of Ofatumumab for Relapsing MS to September The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘Ā ofatumumab, a possible self-administered injection therapy for relapsingĀ multiple sclerosis (MS), the company announced. Originally expected in June, the FDA decision is now expected in September. “Novartis will continue to work with the FDA to…
June 3, 2020 News by Marisa Wexler, MS Zeposia, Daily Oral Treatment for Relapsing MS, Now Available in US ZeposiaĀ (ozanimod), a newly approved oral capsule treatment for relapsing forms of multiple sclerosis (MS), is now commercially available in the United States, its manufacturer, Bristol Myers Squibb,Ā announced. “We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing]…
June 1, 2020 News by Mary Chapman FDA Updates Rebif Label on Pregnancy and Breastfeeding for MS Patients TheĀ U.S. Food and Drug Administration (FDA) approved adding new safety data on pregnancy and breastfeeding to the U.S. label for Rebif (interferon beta-1a), a disease-modifying treatment for relapsing forms of multiple sclerosis (MS). The label update draws on findings from a large population-based study, together with…
May 14, 2020 News by Joana Carvalho, PhD FDA Grants Breakthrough Device Designation to Helius’ PoNS Device The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Helius Medical Technologiesā portable neuromodulation stimulator (PoNS) for the treatment of walking impairments in multiple sclerosis (MS) patients. The device, which is meant to be used…
May 11, 2020 News by Joana Carvalho, PhD MMJ Can Ship Cannabis Products to US for Clinical Testing, Agencies Say MMJ International HoldingsĀ announced that it has been given clearance to ship its cannabis-based products to the U.S. for use in future clinical trials of potential cannabis-based treatment forĀ multiple sclerosis (MS) and Huntingtonās disease. The process was facilitated by the U.S. Drug Enforcement AgencyĀ (DEA), which worked alongside…
May 11, 2020 News by Marisa Wexler, MS FDA Clears Nurocheck, Portable Device to Quickly Assess Brain Health A portable device that can quickly measure electrical activity in the brain and relay it to doctors via a smartphone app, calledĀ the Nurochek system,Ā has been cleared by the United States Food and Drug Administration (FDA) for use as a medical device. Its developer, Headsafe, plans to it…
April 23, 2020 News by InĆŖs Martins, PhD VTS-Aspirin Combos to Ease Flush in RRMS Named Orphan Drug by FDA The U.S. Food and Drug Administration (FDA) has granted orphan drug status to combinations of VTS-Aspirin plus fumarate therapy usingĀ Vumerity (diroximel fumarate) or Bafiertam (monomethyl fumarate) for easing flush in patients with relapsing-remitting multiple sclerosisĀ (RRMS). In the U.S., orphan drug designation is given to…
April 21, 2020 News by Marisa Wexler, MS Shorter Ocrevus Infusion Time Up for Approval in US and Europe The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications from Genentech to shorten the infusion time for Ocrevus, an approved treatment forĀ multiple sclerosis. If approved, the time to administer Ocrevus will be shortened to a two-hour session, instead…
April 6, 2020 News by Marta Figueiredo, PhD Biogen’s Plegridy or Avonex Use Possible in Pregnancy, Breastfeeding, FDA Says Plegridy (peginterferon beta-1a) and Avonex (interferon beta-1a), both by Biogen, may be used ā if necessary ā by women with relapsingĀ multiple sclerosisĀ who are pregnant or breastfeeding, the U.S. Food and Drug Administration (FDA) announced in updating prescribing informationĀ for these MS treatments. Due to the limited…
March 27, 2020 News by Patricia Inacio, PhD Potential Competitor to Acthar Gel Asking to Re-enter US Market ANI Pharmaceuticals is asking the U.S. Food and Drug Administration (FDA) for the right to reintroduce in the U.S. market its Cortrophin Gel (repository corticotropin injection, 80 U/ml) to treat acute exacerbations in multiple sclerosis (MS) and other diseases. Currently, the only repository corticotropin injection available in…
March 26, 2020 News by Marta Figueiredo, PhD FDA Approves Zeposia (Ozanimod), Oral Therapy for All with Relapsing MS The U.S. Food and Drug Administration (FDA) has approved ZeposiaĀ (ozanimod) oral capsules to treat adults with relapsing forms ofĀ multiple sclerosisĀ (MS), includingĀ relapsing-remitting MS (RRMS), Ā active secondary progressive MS (SPMS), and clinically isolated syndromeĀ (CIS). Due to the COVID-19 pandemic, however, when it will arrive in clinics…
March 24, 2020 News by Margarida Azevedo, MSc ImStem Biotechnology to Launch Phase 1 Trial Testing IMS001 for MS The U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the investigational new drug (IND) application to assess IMS001 in the treatment of multiple sclerosis (MS), ImStem Biotechnology announced. The company plans to start a Phase 1 study in the U.S. this…
March 20, 2020 News by Marisa Wexler, MS Janssen Seeks FDA Approval for Oral Ponesimod for Treating Relapsing MS Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) asking for ponesimodĀ to be approved as an oral treatment for adults with relapsingĀ multiple sclerosis (MS). Ponesimod, formerly ACT-128800, is an experimental treatment that targets the proteinĀ sphingosine-1-phosphate…
February 25, 2020 News by Patricia Inacio, PhD Novartis’ Ofatumumab for Relapsing MS Up for Possible Approval by FDA and EMA Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, anĀ investigational B-cell therapy for the treatment of relapsing forms ofĀ multiple sclerosisĀ (MS) in adults. Novartis’ applications for ofatumumab ā which has the…
February 21, 2020 News by Iqra Mumal, MSc Flowonix’s Prometra II Pump System Receives FDA Approval for Use with Intrathecal Baclofen The U.S. Food and Drug Administration (FDA) has granted approval to Flowonix MedicalāsĀ Prometra II Programmable Pump System for use with intrathecal baclofenĀ for the treatment of spasticity across numerous conditions, including multiple sclerosis. Intrathecal baclofen ā sold asĀ Gablofen by Piramal,Ā Lioresal by…
February 5, 2020 News by Alberto Molano, PhD QyScore, Imaging Software that Analyzes MRI Markers of Brain Disease, Earns FDA Clearance The U.S. Food and Drug Administration (FDA) has grantedĀ 510(k) clearance forĀ QyScore, a cloud-based imaging software for the automated quantification of key magnetic resonance imaging (MRI) markers of central nervous system (CNS) disease. MRI is an important tool for diagnosing multiple sclerosis and other CNS disorders. By…
January 29, 2020 News by Marta Figueiredo, PhD New Imaging Agent of Myelin for Earlier MS Diagnosis, Myeliviz, Entering Clinical Testing TheĀ U.S. Food and Drug AdministrationĀ (FDA)Ā has agreed to allow Myeliviz, an imaging agent of myelin ā the protective layer that covers nerve fibers and isĀ damaged inĀ multiple sclerosisĀ (MS) ā to be evaluated in a clinical trial with healthy volunteers. Myeliviz, created byĀ Case Western Reserve UniversityĀ researchers, has the potential…
January 10, 2020 News by Catarina Silva Vitalis Plans to Launch Phase 3 Trial Testing VTS-72 as Treatment for RRMS-related Flushing Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing ā facial redness, itching or rash ā in patients with relapsing-remitting multiple sclerosisĀ (RRMS). Flushing is a common side effect of an oral MS therapy called…
January 3, 2020 News by Marisa Wexler, MS Gabapentinoid Use to Control MS Pain Can Lead to Respiratory Problems, FDA Warns Gabapentinoids ā a class of therapies sometimes used off-label to help control pain in people with multiple sclerosis (MS) ā can increase the risk of serious breathing problems, particularly for those who have risk factors like poorer lung function or use opioid pain medicines, according to a warning…
December 6, 2019 News by Joana Carvalho, PhD FDA Approves Three Generic Versions of Novartis’ Gilenya for Treating Relapsing MS The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…
November 20, 2019 News by Alice MelĆ£o, MSc MMJ Enters Agreement to Produce Cannabis-based Capsules for Clinical Trials in MS and Huntingtonās MMJ International HoldingsĀ announced that it has entered into an agreement for the production of its proprietary cannabis-based gel capsule ā a product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) ā in compliance with guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
October 30, 2019 News by Patricia Inacio, PhD Vumerity Approved in US as Treatment for RRMS and Active SPMS The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate)Ā for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…
August 14, 2019 News by Joana Carvalho, PhD US Agency Asked to OK Cannabinoid Shipments from Canada to Support Studies in MS, MMJ Announces MMJ International Holdings, a pharmaceutical company whose focus is plant-derived cannabis products for therapeutic purposes, has requested permission to ship tetrahydrocannabinol (THC) and cannabidiol (CBD) from Canada to the U.S. to be used in upcoming clinical trials for people with multiple sclerosis (MS) and Huntington’s disease. MMJ-001…
July 16, 2019 News by Marisa Wexler, MS Independent Mouse Study Reinforces Remyelinating Potential of ISP Therapy A new study demonstrates that intracellular sigma peptide (ISP) can promote remyelination in a mouse model of multiple sclerosis (MS). Importantly, this study was independent of NervGen, a pharmaceutical company that is developing an ISP-like compound āĀ NVG-291Ā ā for the treatment of nerve injury and MS. The study,…
July 9, 2019 Columns by Ed Tobias CBD Oil: Panacea or Placebo? Last night in bed, my calf muscles started cramping. Again. Usually, it’s just my left leg, but last night it was both. The pain wouldn’t ease with my usual stretching routine so I reached for my little bottle of cannabidiol (CBD) oil. I’ve been experimenting with CBD oil on and…
June 25, 2019 News by Ana Pena PhD FDA Approves Botox to Treat Upper Limb Spasticity in Children Aged 2 to 17 The U.S. Food and Drug Administration (FDA) has approved the use of Botox (onabotulinumtoxinA), marketed by Allergan, for the treatment of children ages 2 to 17 with upper limb muscle stiffness or spasticity, a common symptom inĀ children with…
June 10, 2019 Columns by Ed Tobias MS News That Caught My Eye Last Week: Ozanimod for RRMS, MS Monitoring App, Video Series FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS Another disease-modifying therapy (DMT) is a step closer to gaining approval for use both in the U.S. and in Europe. And that’s good news. The discouraging news, however, is that once again, the approval is being…
June 7, 2019 News by Joana Carvalho, PhD FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both agreed to review for possible approvalĀ ozanimod, Celgene‘s investigational oral therapy for relapsing forms of multiple sclerosis (MS). An FDA decision on the company’sĀ New Drug Application for ozanimod is expected on…
April 1, 2019 News by Joana Carvalho, PhD FDA Approves EMD Serono’s Mavenclad as Treatment for RRMS and Active SPMS The U.S. Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) andĀ active secondary progressive disease (SPMS). Up to 85 percent of people with MS are initially diagnosed…