17:49 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Priority Review for Alexion's long-acting PNH therapy

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said FDA accepted and granted Priority Review to its BLA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria. Its PDUFA date is Feb. 18, 2019. ALXN1210 is a long-acting humanized mAb targeting complement...
14:28 , Aug 20, 2018 |  BC Extra  |  Company News

Priority Review for Alexion's long-acting PNH therapy

Alexion Inc. (NASDAQ:ALXN) said FDA accepted and granted Priority Review to its BLA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria. Its PDUFA date is Feb. 18, 2019. ALXN1210 is a long-acting humanized mAb targeting complement 5...
00:46 , Aug 4, 2018 |  BioCentury  |  Finance

Functions of formulation

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can...
22:10 , Aug 3, 2018 |  BC Extra  |  Politics & Policy

ICER announces preliminary 2019 topics

The Institute for Clinical and Economic Review (ICER) released Thursday a preliminary list of drugs and other healthcare interventions that it may review in 2019. ICER's selection criteria include the projected timing and likelihood of...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
20:44 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

Alexion submits BLA for long-acting C5 inhibitor for PNH

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) submitted a BLA to FDA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria (PNH) using a rare disease Priority Review voucher. The submission is based on data from the Phase III ALXN1210-PNH-301 and...
17:58 , May 11, 2018 |  BC Week In Review  |  Company News

EPO rejects Soliris patent, schedules oral hearing

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said the European Patent Office has rejected a patent that would extend exclusivity through 2027 for rare disease drug Soliris eculizumab. An oral hearing has been scheduled for Feb. 5, 2019. The...
20:39 , May 8, 2018 |  BC Extra  |  Company News

EPO rejects Soliris patent, schedules oral hearing

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said the European Patent Office has rejected a patent that would extend exclusivity through 2027 for rare disease drug Soliris eculizumab. An oral hearing has been scheduled for Feb. 5, 2019. The...
19:51 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

Alexion's long-acting C5 inhibitor meets in Phase III switch trial

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) reported in its 1Q18 earnings release on April 26 that ALXN1210, its long-acting formulation of Soliris eculizumab, met the primary and four key secondary endpoints in the the Phase III ALXN1210-PNH-302...