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Alvogen announced the launch of RemurelTM (glatiramer acetate), the first generic equivalent of CopaxoneTM in Central and Eastern Europe. The product will be marketed as a once daily subcutaneous 20 mg prefilled syringe under the brand name RemurelTM and will be launched throughout all Central and Eastern European countries from September 2016 onwards.
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CTD Holdings, Inc. announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for its orphan drug product Trappsol® Cyclo™ in the treatment of Niemann-Pick Type C (NPC) disease. CTD will be initiating a Phase I study to investigate safety, tolerability, pharmacokinetic parameters and pharmacological effects of the intravenous administration of Trappsol® Cyclo™, CTD's hydroxypropyl beta cyclodextrin. Trappsol® Cyclo™ has Orphan Drug Designation in both the EU and the US.
Catalyst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for Firdapse® (amifampridine phosphate) for the treatment of myasthenia gravis.
Sangamo BioSciences, Inc. Announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-FIX, the company's zinc finger nuclease (ZFN)-mediated genome editing product candidate for the treatment of hemophilia B. Sangamo expects to initiate a Phase 1/2 clinical study (SB-FIX-1501) in adult subjects with the disease in 2016.
Sun Pharma announced the initiation of a phased transfer of manufacturing & marketing rights in Japan for the 14 long-listed/established prescription brands acquired from Novartis. These 14 prescription brands acquired by the company earlier this year will be transferred from Novartis Pharma K.K. to Sun Pharma’s subsidiary in Japan beginning October 2016.
Elite Pharmaceuticals, Inc. announced it has entered into a Development and License Agreement (“Agreement”) with SunGen Pharma, LLC (“SunGen”) to collaborate to develop and commercialize four generic pharmaceutical products
In line with the vision of Shri Narendra Modi, Hon’ble Prime Minister of India to eradicate Leprosy from India, Shri J P Nadda, Union Minister of Health and Family Welfare reviewed the National Leprosy Eradication Programme and pursuant to that, Ministry of Health and Family Welfare has launched the biggest Leprosy Case Detection Campaign (LCDC) in the country on 5th September 2016 across 149 districts of 19 states/UTs.
Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, as indicated by the presence of eosinophils in their blood.
Amgen and Boehringer Ingelheim announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836909 (AMG 420), a bispecific T cell engager (BiTE®) that targets B-cell maturation antigen (BCMA), a potential target for multiple myeloma. BI 836909 (AMG 420) is currently in Phase 1 studies. BI 836909 (AMG 420) was originally licensed to Boehringer Ingelheim by Micromet before the company was acquired by Amgen in 2012.
MiMedx Group, Inc., the leading regenerative medicine company, announced its plans for the nationwide launch of AmnioFill, the first product in the MiMedx placental collagen matrix product family to be commercially launched.
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