21:10 , Dec 30, 2016 |  BC Week In Review  |  Clinical News

Anagrelide CR regulatory update

Galena said FDA confirmed that a Phase III trial comparing anagrelide CR vs. best available therapy in patients with essential thrombocythemia would be appropriate for an NDA submission using the 505(b)(2) pathway. The trial, which...
07:00 , Aug 1, 2016 |  BC Week In Review  |  Clinical News

Jakafi: Phase III data

Top-line data from the open-label, crossover, international Phase III RESPONSE-2 trial in 149 PV patients who were resistant to or intolerant of hydroxyurea, who were dependent on phlebotomy for hematocrit control and who did not...
08:00 , Jan 18, 2016 |  BioCentury  |  Strategy

Shire's serial story

The most obvious benefits Shire plc expects to gain by acquiring Baxalta Inc. are a slew of new products and the cash to make subsequent acquisitions the company couldn't have made on its own. But...
07:00 , Aug 10, 2015 |  BioCentury  |  Strategy

Shire's M&A stepping stone

Shire plc's unsolicited $30 billion bid for Baxalta Inc. may be transformative in creating a leading rare disease company, but not as an end game in itself. Rather, a merger could provide Shire with the...
07:00 , Jun 22, 2015 |  BC Week In Review  |  Clinical News

Anagrelide CR: Updated Phase II data

Updated data from an open-label, U.S. Phase II trial in 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms showed that twice-daily oral GALE-401 led to an overall response rate...
07:00 , Jun 15, 2015 |  BC Week In Review  |  Clinical News

Anagrelide CR: Additional Phase II data

Additional data from an open-label, U.S. Phase II trial in 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms showed that twice-daily oral GALE-401 led to an overall response rate...
08:00 , Jan 26, 2015 |  BC Week In Review  |  Clinical News

Anagrelide CR: Preliminary Phase II data

Preliminary data from an open-label, U.S. Phase II trial in 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms showed that twice-daily oral GALE-401 led to a confirmed or unconfirmed...
08:00 , Dec 8, 2014 |  BC Week In Review  |  Clinical News

Anagrelide CR: Completed Phase II enrollment

Galena completed enrollment of 18 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms in an open-label, U.S. Phase II trial of oral GALE-401 twice daily for =24 weeks. Patients will...
08:00 , Nov 17, 2014 |  BC Week In Review  |  Company News

AOP Orphan sales and marketing update

AOP Orphan launched Thromboreductin anagrelide in Russia to treat essential thrombocythemia. The product comes in 0.5 mg capsules. AOP Orphan Pharmaceuticals AG , Vienna, Austria   Business: Hematology  ...
07:00 , Sep 22, 2014 |  BC Week In Review  |  Clinical News

Anagrelide CR: Phase II started

Galena began an open-label, U.S. Phase II trial to evaluate oral GALE-401 twice daily for >=24 weeks in about 20 patients with elevated platelet counts secondary to essential thrombocythemia and other myeloproliferative neoplasms. Patients will...