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February 1, 2013
13:25 EDTBMRN, BMRN, BMRN, CLVS, CLVS, CLVS, TSRO, TSRO, TSROLeerink's biotech analysts hold an analyst/industry conference call
Biotech Analysts Kozul, Liang and Schwartz provide a review of development programs for novel oral PARPs (Poly(ADP-ribose) polymerase); Biomarin's BMN-673, Clovis Oncology's Rucaparin and Tesaro's Niraparib on an Analyst/Industry conference call to be held on February 4 at 2 pm.
News For BMRN;CLVS;TSRO 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 29, 2014
07:09 EDTCLVSClovis can remain ahead of competitor, says Stifel
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06:02 EDTCLVSAstraZeneca data raises bar for Clovis, says Mizuho
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September 28, 2014
12:42 EDTCLVSClovis announces preliminary Phase 2 results from the ARIEL2
Clovis Oncology announced preliminary Phase 2 results from the ARIEL2, Assessment of Rucaparib In Ovarian Cancer Trial, study and updated results from the ongoing Phase 1/2 monotherapy study of rucaparib. Rucaparib is the company’s investigational oral, potent, small molecule inhibitor of PARP1 and PARP2 being developed for the treatment of platinum-sensitive ovarian cancer in patients with homologous recombination deficient tumors, defined as those with BRCA mutations and other DNA repair deficiencies. These data are being presented today at the European Society of Medical Oncology 2014 Congress in Madrid. "New treatments are desperately needed for women with ovarian cancer. The data presented for rucaparib in ovarian cancer demonstrate compelling clinical activity and tolerability in patients with BRCA mutations,” said Professor Iain McNeish, Professor of Gynaecological Oncology, Institute of Cancer Sciences, University of Glasgow and one of the two principal investigators of the ARIEL2 study. “Even more encouraging are the preliminary data from ARIEL2, which show that tumor HRD analysis can identify a broader range of patients who may benefit from rucaparib therapy. HRD analysis may be a more robust and precise method to select patients for PARP inhibitor therapy than platinum sensitivity alone. I am delighted to be involved in this study, which may ultimately lead to an additional treatment option, not only for germline BRCA mutation carriers but also for large numbers of ovarian cancer patients, for whom few options exist today.” “We are enthusiastic about the possibility of identifying ovarian cancer patients beyond those with germline BRCA mutations who may benefit from rucaparib therapy with the ARIEL2 study,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “And we look forward to sharing the first clinical outcome data at the ENA Symposium in November, which were accepted for an oral plenary session. We believe we are the only company seeking to prospectively demonstrate a PARP inhibitor’s activity in a molecularly-selected ovarian cancer population beyond germline BRCA mutations, and this may have the potential to meaningfully differentiate rucaparib.”
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 22, 2014
16:02 EDTTSROTESARO files to sell $165M of convertible senior notes due 2021
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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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