Articles By Estel Grace Masangkay
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EMA Backs MorphoSys' Orphan Application For MOR208 In DLCBL
12/18/2014
MorphoSys, a company specializing in developing therapeutic antibodies, announced that it has received the positive opinion of the European Medicines Agency for the Orphan Medicinal Product Designation application of its drug MOR208 as a treatment for diffuse large B-cell lymphoma (DLBCL).
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X-Chem, Alexion To Develop Drugs For Ultra-Rare Disorders
12/17/2014
X-Chem, a private biotech firm developing novel small molecule drugs via its DNA-encoded library platform, announced that it has entered into a drug discovery partnership with Alexion to jointly develop treatments for severe and ultra-rare disorders.
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Sanofi Opens New Production Facility In KAEC Saudi Arabia
12/16/2014
French pharma giant Sanofi has formally inaugurated its new production facility at King Abdullah Economic City in Saudi Arabia.
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Jazz Pharma Begins Rolling NDA For Defibrotide In Hepatic VOD
12/16/2014
Jazz Pharmaceuticals announced that it has started the rolling submission of a New Drug Application (NDA) for defibrotide as treatment for severe hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy.
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Bayer, DNDi To Develop Drug For Human River Blindness
12/15/2014
German pharma firm Bayer announced that it has signed an agreement with Drugs for Neglected Diseases initiative (DNDi) to develop the company’s emodepside as a new oral treatment for river blindness, also known as onchocerciasis.
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Ariad Posts Phase 2 Data For Iclusig In CML And Ph+ ALL
12/15/2014
Ariad Pharmaceuticals reported long-term data from its pivotal Phase 2 trial of Iclusig (ponatinib) in chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
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Insys Receives FDA Orphan Status For Gastric Cancer Drug
12/12/2014
Specialty pharmaceutical firm Insys Therapeutics announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) drug lead for gastric cancer.
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Novartis' Jakavi Safe And Effective In Phase 3B Myelofibrosis Trial
12/11/2014
Novartis reported that its blood cancer drug Jakavi (ruxolitinib) was safe and effective in treating patients with myelofibrosis in a Phase 3B trial.
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Pfizer Inks Gene Therapy Partnership With Spark Therapeutics
12/11/2014
Pfizer announced two major moves that will expand its rare disease R&D activities. First, the company said it will establish a gene therapy platform through its newly inked agreement with Spark Therapeutics. Secondly, it has appointed Dr. Michael Linden, Director of the University College London Gene Therapy Consortium, as head of Pfizer’s gene therapy research in rare diseases area.
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Sunovion Files sNDA With FDA For Aptiom In Seizures
12/11/2014
Sunovion Pharmaceuticals announced its filing of a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for its drug Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures.