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...