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News Breaks
May 2, 2014
06:11 EDTBMRNBioMarin says BMN 165-302 study to be available in Q4 of 2015
BioMarin announced last night that it intends to modify the entry criteria for the BMN 165-302 randomized discontinuation study. "The purpose of the eligibility modification is to leverage those patients who have relatively weaker immune reactions to PEG PAL, who therefore achieve Phe reductions faster, at relatively lower doses and with relatively fewer side effects. Under the revised entry criteria, patients will need to demonstrate a pre-specified reduction in blood Phe from PEG PAL during the BMN 165-301 feeder study prior to entering the BMN 165-302 RDT study," it stated. Based on the changed BMN 165-302 protocol, associated review of the proposed protocol and preliminary BMN 165-301 data with the FDA, and requirement for additional patients, the company now expects data from the enriched BMN 165-302 study to be available in Q4 of 2015.
News For BMRN From The Last 14 Days
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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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