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- Read more about FDA Accept CTD Holdings IND Application for Treatment of NPC With Trappsol(R) Cyclo(TM)
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.
- Read more about FDA grant Orphan Drug Designation to Catalyst Pharmaceuticals for Firdapse
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.
- Read more about FDA grant Sangamo BioSciences Orphan Drug Designation For SB-FIX
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.
- Read more about Sun Pharma initiate distribution alliance with Mitsubishi Tanabe Pharma Corporation in Japan
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.
- Read more about Elite Initiate Development and License Agreement with SunGen Pharma LLC
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
- Read more about 32 crore persons to be screened for Leprosy in India : Health Ministry
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.
- Read more about Astrazeneca’s Benralizumab phase III trials show positive results in severe asthma
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.
- Read more about Amgen acquire global development and commercial rights from Boehringer Ingelheim for investigational BiTE immuno-oncology drug
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.
- Read more about MiMedx introduce placental collagen matrix product, AmnioFill in US market
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.
- Read more about FDA Conditionally Accept Neurocrine’s Proprietary Name INGREZZA for VMAT2 Inhibitor Valbenazine
Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name "INGREZZA™" for the Company's once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine. The Company has recently announced the submission of a New Drug Application (NDA) with the FDA for valbenazine in tardive dyskinesia and is also exploring its utility in Tourette syndrome.

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