FDA

News that the U.S. Food and Drug Administration (FDA) is to hold a public hearing next month to consider greater oversight of stem cell clinics operating in the country is as welcome as it is late. I say “late” because, while the regulators have been twiddling their fingers,…

The U.S. Food and Drug Administration (FDA) has designated TG-1101 (ublituximab), a glycoengineered anti-CD20 monoclonal antibody by TG Therapeutics, an orphan drug to advance its development. The drug is a potential treatment for neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD), two relapsing-remitting autoimmune diseases with similarities to multiple sclerosis. Currently, there are…

The Patient-Centered Outcomes Research Institute (PCORI) recently awarded a sum of $5.5 million to two researchers at the University of California, San Francisco (UCSF). Bardia Nourbakhsh, MD. (Credit: UCSF) Bardia Nourbakhsh, MD, a clinical fellow in Neurology, received a $2 million grant to conduct a randomized, double-blind, placebo-controlled clinical trial to…

Stem cell clinics are proliferating in the U.S., where there are now 570 in operation, according to a paper quoted by the New York Times. And concerns are being raised that these clinics are often operating and making claims beyond those allowed by the country’s public health regulatory…

Oral therapy Tecfidera (dimethyl fumarate) seems to be emerging as a first-line treatment for relapsing multiple sclerosis – according to Biogen, the company that developed it. That’s good news, and something we need to know. The company agrees that for some time, the long-term effectiveness and safety of this oral…

The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or…

Zinbryta (daclizumab) was approved May 27 for the treatment of adults with relapsing multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) cleared Biogen’s new long-acting injection as a patient self-administered monthly therapy. The director of Neurology Products at the U.S. FDA’s Center for Drug Evaluation…

PathMaker Neurosystems, Inc., recently announced the launch of an Institutional Review Board (IRB)-approved clinical trial, in partnership with Northwell Health (formerly North Shore-LIJ Health System) and The Feinstein Institute for Medical Research, to evaluate the safety and efficacy of MyoRegulator for the treatment of spasticity, one of the most common symptoms in multiple sclerosis…

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…

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…

The U.S. Food and Drug Administration (FDA) will hold a one-day public hearing on four recent draft guidelines regarding the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). Critics of the proposed regulations warn that they curtail the medical use of autologous cell therapy and biologics, and their future potential…

The Tisch MS Research Center of New York (Tisch MSRCNY) recently announced that its stem cell-based therapy as a potential treatment for multiple sclerosis (MS) will move into Phase 2 clinical testing after encouraging results in a Phase 1 trial, and on the advice of  the U.S. Food and Drug…

Alkermes plc, a fully integrated global biopharmaceutical company, recently provided a regulatory update and positive clinical trial data for ALKS 8700, an oral, innovative and proprietary monomethyl fumarate (MMF) compound that is being developed to treat multiple sclerosis (MS). ALKS 8700 is being developed to quickly and efficiently convert…

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…

Multiple sclerosis patients prescribed Gilenya (fingolimod) are now being informed about a handful of documented cases where the therapy was found to have led to a rare brain infection, according to the US Food and Drug Administration. The FDA has released a public warning indicating that cases of progressive multifocal leukoencephalopathy (PML) have been…

Skin problems may be caused by interferon-β, a common treatment for multiple sclerosis (MS), according to a new study published by a German research group at the Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, in Würzburg, Germany. The work, entitled “Cutaneous Adverse Events Associated with Interferon-β…

Nano-drugs encased in liposomes could one day be used to treat neurological diseases like multiple sclerosis (MS), according to a new study published July 6th in the journal, PloS One. A liposome is a small, fat soluble droplet that can contain a water soluble drug. Liposomes might…

In an effort to access firsthand patient data as a means of improving healthcare and drug safety, the Food and Drug Administration (FDA) has announced a unique partnership with  PatientsLikeMe, an online network of 350,000 patients who have reported on their own personal experiences in living with over 2,500 different diseases. The…

The Allegheny General Hospital in Pennsylvania is now offering a new treatment option for people with relapsing remitting multiple sclerosis (RRMS) — the most common form of multiple sclerosis.  The treatment may help people with RRMS who have not responded to other medications. MS is an autoimmune disorder in which the…

The Myelin Repair Foundation (MRF) and National Institutes of Health (NIH) will initiate a clinical trial of guanabenz in people with multiple sclerosis (MS). Guanabenz is FDA-approved for high blood pressure, but it may also prevent myelin loss. The drug could be the first for MS to protect myelin from…

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…

Genzyme presented new magnetic resonance imaging (MRI) data from the Lemtrada® (alemtuzumab) clinical development program on April 23, 2015, at the 67th American Academy of Neurology (AAN) Annual Meeting. The company showed that in the extension phase of two Phase III trials (years 3 and 4), the drug continued to protect the nervous…

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…

Biogen plans to present new clinical data at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington D.C., April 18 – 25, 2015, including numerous presentations focusing on multiple sclerosis.  In a company press release, Biogen stated “At AAN, we will feature new scientific data, including research highlighting the…

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)…

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,…

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…

One of the concerns patients with neurologic diseases such as multiple sclerosis face is decline or loss of bladder control. It can be an embarrassing and frustrating problem, which is estimated to occur in about 80% of MS patients, as the disease causes a slowing down or interruption in signal transmission…