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Mylan N.V. announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.
GSK announced that dosing has commenced in a phase III study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of patients with giant cell arteritis (GCA).
Takeda Pharmaceutical Company Limited announced that the multiple sclerosis treatment drug, "Copaxone® Subcutaneous Injection 20 mg Syringe" (generic name: glatiramer acetate, hereinafter "Copaxone") has become available in Japan.
This drug has been developed by Teva Pharmaceutical Industries Ltd. (Head office Petah Tikva, Israel hereinafter "Teva") as a subcutaneous injection administered once daily, to prevent the relapse of multiple sclerosis. Copaxone was designated as an orphan drug by the Japanese Ministry of Health, Labour and Welfare (MHLW) in March 2009, and a request was received from the MHLW in May 2010 for its development as an "unapproved drug highly needed in medical care". In March 2013, Takeda and Teva entered into a licensing agreement for commercialization of this drug in Japan, and on September 28, 2015 Takeda obtained NDA approval.
Multiple sclerosis is assumed to be an autoimmune disease, the hallmark sign of which is inflammatory demyelination of the central nervous system characterized by demyelinating plaques in the brain and the spinal cord. Common symptoms of multiple sclerosis include visual problems, ocular motor abnormality, paresthesia, muscle weakness, spasticity, urinary dysfunction, and cognitive impairment. This disease may present as a primary progressive type, which takes a chronic progressive course from its early onset; a relapsing-remitting type, which repeats a pattern of relapse and remission; or a secondary progressive type that shifts to a progressive course later. More than 80% of patients are categorized as having the relapsing-remitting type. Multiple sclerosis is estimated to affect approximately 18,000 individuals in Japan, with its prevalence tending to increase.
"Copaxone, one of the most frequently used drugs in multiple sclerosis, is approved in more than 50 countries worldwide, and is expected to represent a new treatment option for Japanese patients," said Masato Iwasaki, Ph.D., Director and President, Japan Pharma Business Unit of Takeda. "Takeda will continue to be committed to delivering drugs for diseases that remain as high unmet medical needs for both patients and physicians".
Men with Type 2 diabetes who have low testosterone levels can benefit significantly from testosterone treatment, says a new study led by an Indian-American doctor.
Medicines do not appear to degrade faster in the zero-gravity atmosphere on the International Space Station (ISS) and this does not differ from what is typically seen on the Earth, researchers report.
Children who are left without direct parental care for extended periods of time show larger gray matter volumes in the brain and may also show delay in brain development, according to a new study.
Chikungunya, a mosquito-borne virus, can lead to severe brain infection and even death in infants and people over 65, a study says. The study showed that the rate of brain infection, or encephalitis, from the chikungunya virus is higher than the rate seen in the US due to West Nile virus and similar infections between 1999 and 2007.
A component of aspirin can block a cell death associated with neurodegenerative diseases like Alzheimer's, Parkinson's and Huntington's disease, a new study says.
The World Health (WHO) Organisation and the United Nations Children's Fund (UNICEF) support Myanmar's Ministry of Health to conduct a polio vaccination campaign in 102 townships across the country, a joint statement from WHO and UNICEF.
The central government will invest Rs.1,700 crore to transform the NISH here into the National University for Rehabilitation Sciences and Disability Studies for the benefit of the disabled, union Social Justice and Empowerment Minister Thaawar Chand Gehlot said on Saturday.
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