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Otonomy’s renaissance starts as Ménière’s disease drug clears trial
fiercebiotech
November 10, 2017
Just weeks after a phase 3 setback caused it to slash staff and R&D programs, Otonomy has bounced back with a positive late-stage trial for its lead candidate Otividex in Ménière’s disease.
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US clears first therapy for Batten disease
pharmatimes
May 02, 2017
US regulators have approved BioMarin Pharmaceutical’s Brineura as the first treatment for a rare inherited form of Batten disease.
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NICE backs new option for Crohn’s disease
pharmatimes
May 02, 2017
The National Institute for Health and Care Excellence is backing the use of Janssen’s biologic Stelara to treat adult...
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BioMarin’s Brineura receives positive opinion from CHMP to treat CLN2 disease
pharmaceutical-technology
April 25, 2017
BioMarin Pharmaceutical has announced that European Medicines Agency’s (EMA) Committee for Medicinal Products...
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Breakthrough multiple sclerosis research sheds light on cause of the disease
pharmafile
April 25, 2017
Researchers from the Universities of Exeter and Alberta have identified a protein in the brain which they believe could be key in the onset of multiple sclerosis.
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Zambon launches Xadago in Portugal to treat Parkinson’s disease
pharmaceutical-technology
April 12, 2017
Italian pharmaceutical company Zambon and its partner Newron Pharmaceuticals have launched Xadago (safinamide) in ...
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AbbVie/Janssen’s Imbruvica filed for graft-versus-host-disease
pharmatimes
April 07, 2017
US regulators have agreed to review AbbVie and Janssen’s Imbruvica for previously treated chronic ...
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US FDA approves Xadago to treat patients with Parkinson’s disease
pharmaceutical-technology
March 23, 2017
The US Food and Drug Administration (FDA) has approved Newron Pharmaceuticals’ Xadago (safinamide) tablets to ...
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Circassia to acquire US rights to Tudorza and Duaklir from AstraZeneca for $230m
pharmaceutical-technology
March 21, 2017
UK-based specialty biopharmaceutical company Circassia Pharmaceuticals has reached an agreement for the transformational acquisition of US commercial rights to two chronic obstructive pulmonary disease (COPD) products from AstraZeneca for a maximum total
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Rare disease patients in UK wait average of two years for medications
pharmaceutical-technology
March 16, 2017
A new report published by Irish biotechnology company Shire has shown that rare disease patients in England...