Kuickresearch::Industry News

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Gamida Cell Announces orphan drug designation for NiCord®

Release Date: 08 April 2017

European Medicine Agency (EMA) has announced orphan drug status for NiCordandreg; developed by Gamida cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, to treat haematopoietic stem c...

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EU Commission grants orphan drug status to ZX008 in Lennox Gastaut Syndrome

Release Date: 08 April 2017

Zogenix Inc., a leading biopharmaceutical company dedicated to develop therapies to treat orphan and central nervous system (CNS) disorders, declared that European Commission has announced orphan drug designation for the company’s&...

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EMA grants orphan drug designation to Epidiolex® from GW Pharmaceuticals

Release Date: 07 April 2017

GW Pharmaceuticals has announced that European Medicine Agency has granted orphan drug designation to its leading product candidate, Epidiolexandreg; (cannabidiol or CBD) for effective treatment of the treatment of Lennox-Gastaut Syndrom...

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CAEL-101 from Fortress Biotech (FBIO) Receives Orphan Drug Designations for Amyloidosis

Release Date: 07 April 2017

U.S. Department of Health and Human Services has confirmed the transfer of two U.S. Food and Drug Administration (FDA) Orphan Drug Designations for CAEL-101 (also known as 11-1F4) from Columbia University (“Columbia”) to Fort...

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Dynport’s Plague vaccine receives orphan drug status from FDA

Release Date: 06 April 2017

DynPort Vaccine Company LLC (DVC), a subsidiary of CSRA, announced that its plague vaccine has received orphan drug designation from US Food and Drug Administration. DVC is developing the recombinant rF1V plague vaccine on behalf of the ...

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Boehringer Ingelheim's investigational anti-CD33 monoclonal antibody BI 836858 receives FDA orphan drug status

Release Date: 06 April 2017

US Food and Drug Administration has announced orphan drug designation for         Boehringer Ingelheim's investigational anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic synd...

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ChemoCentryx announces FDA orphan drug designation for Avacopan in the Treatment of Debilitating Kidney Disease C3 Glomerulopathy (C3G)

Release Date: 05 April 2017

US Food and Drug Administration (FDA) have announced orphan drug designation for chemocentryx’s leading product candidate, avacopan for the treatment of patients suffering with Debilitating Kidney Disease C3 Glomerulopathy (C3G). C...

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EU Commission grants orphan drug designation to Abeona’s EB101 Gene Therapy

Release Date: 04 April 2017

Abeona Therapeutics, a leading pharmaceutical company recently announced that European Medicine Agency has granted orphan drug designation to its leading gene therapy candidate, EB 101 for effective treatment of patient with Epidermolysi...

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Yeliva receives FDA orphan drug status for cholangiocarcinoma

Release Date: 03 April 2017

US Food and Drug Administration has granted orphan drug designation to Yeliva a first-in-class, orally administered, sphingosine kinase-2 selective inhibitor with anticancer and anti-inflammatory activities, for the effective treatment o...

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Minoryx therapeutics announces orphan drug designation for MIN-102

Release Date: 27 March 2017

Minoryx Theapeutics, a leading drug development company focused on developing orphan drugs for rare diseases recently, announced that US Food and Drug Administration (FDA) has granted orphan drug designation to its leading product candid...

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Protalex receives orphan drug designation for ITP

Release Date: 25 March 2017

Protalex, a biopharmaceutical company dedicated to develop orphan drug or therapies for the effective treatment of patients with rare diseases, has recently announced that its novel drug candidate, PRTX 100 has been granted orphan drug d...

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FDA grants orphan drug status to ZW25 for Gastric Cancer Treatment

Release Date: 24 March 2017

US Food and Drug Administration has awarded orphan drug designation to Zymework’s leading product candidate, ZW25 for the treatment of gastric cancer and cancer of the gastroesophageal junction (GEJ). Presently, the dug is being ex...

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Immune design receives orphan drug status for G100 Intratumoral therapy Candidate

Release Date: 23 March 2017

Immune Design, a biopharmaceutical company focused on developing drugs and therapies for oncology has declared receipt of orphan drug designation by US Food and Drug Administration (FDA) for its investigational therapy G100 for the treat...

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FDA grants orphan drug designation to Sangamo’s SB-318

Release Date: 22 February 2017

Sangamo Biosciences Inc., a biopharmaceutical company announced that US Food and Drug Administration has granted orphan drug designation to its genome editing candidate, SB-319 for the treatment of Mucopolysaccharidosis Type I (MPS I), a...

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FDA grants orphan drug status to Vicore

Release Date: 21 February 2017

US Food and Drug Administration has awarded Vicore Pharmaceuticals with orphan Drug designation for the treatment of Idiopathic Pulmonary Fibrosis (IPF). FDA's Orphan Drug Designation program provides certain incentives for companies dev...

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