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News Breaks
May 27, 2014
08:40 EDTBMRNBioMarin doses first patient in Phase 3 INSPIRE trial with BMN 701
BioMarin announced that it has dosed the first patient with BMN 701 in the Phase 3 INSPIRE trial for Pompe disease. BMN 701 is a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidas, designed to target delivery to the lysosomes where the enzyme is most needed. The INSPIRE trial focuses on late onset Pompe disease an inherited condition caused by a deficiency in the lysosomal enzyme acid alpha glucosidase, which can lead to progressive weakening of the muscles of the body, including the diaphragm, a crucial respiratory muscle. Respiratory impairment is the leading cause of morbidity and mortality in late onset Pompe disease.
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September 30, 2014
07:48 EDTBMRNJefferies to hold a summit
Gene Therapy Summit for Hemophilia & Hemoglobinopathies to be held in Boston on September 30.
September 24, 2014
17:25 EDTBMRNBioMarin submits Paragraph IV notice letter for Kuvan tablets to the FDA
BioMarin announced that a Paragraph IV Certification Notice Letter was submitted to the FDA in connection with an Abbreviated New Drug Application to the FDA for approval to market a generic version of Kuvan Tablets, although it has not yet received notice of the certification. BioMarin will evaluate the Paragraph IV certification when it receives the Notice Letter and intends to enforce its intellectual property rights. Once the lawsuit is filed, the 30 month stay period will begin as of the date BioMarin was notified of the filing.
10:01 EDTBMRNBioMarin drops 1% after FDA posts Kuvan Paragraph IV Patent challenge
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09:57 EDTBMRNFDA posts Paragraph IV Patent challenge to BioMarin's Kuvan
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September 18, 2014
12:18 EDTBMRNPiper Jaffray biopharm analyst holds an analyst/industry conference call
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September 17, 2014
07:43 EDTBMRNBofA/Merrill to hold a conference
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