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May 17, 2013
Sanofi is getting ready to file its JAK2 inhibitor for myelofibrosis on strong late-stage data for the rare, but serious blood disease
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May 01, 2013
As anticipated, GSK has filed its experimental COPD drug umeclidinium bromide in the US, hot on the heels of a filing in Europe just days ago.
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April 11, 2013
Merck & Co says that a New Drug Application for a tablet formulation of the company's antifungal Noxafil has been accepted for review by the US Food and Drug Administration
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March 28, 2013
Merck & Co has announced that its BL) for its Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the US Food and Drug Administration
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February 26, 2013
AstraZeneca has presented positive data from a late-stage trial of naloxegol in patients with non-cancer related pain and opioid-induced constipation
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February 20, 2013
Gilead Sciences will submit its new hepatitis C drug sofosbuvir for regulatory approvals in the second quarter after presenting positive data from its fourth and final Phase III study
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December 14, 2012
Actelion has been boosted by the news that regulators in the USA have officially accepted a New Drug Application for macitentan, the successor to the Swiss biotech's blockbuster Tracleer.
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September 27, 2012
Biogen Idec and Swedish Orphan Biovitrum have presented promising late-stage data on an investigational drug for haemophilia B, which will be filed in the USA by the biotech major next year
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September 21, 2012
Lundbeck has filed a new generation of antidepressant, vortioxetine, with the European Medicines Agency
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September 18, 2012
Merck KGaA has withdrawn a filing in Europe to extend the use of its blockbuster Erbitux in patients with lung cancer after regulators required more information
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