22:58 , Sep 14, 2018 |  BioCentury  |  Regulation

Closing NICE’s Orphan gap

As the list of Orphan drugs rejected by NICE grows, industry and patient groups are pressuring the agency to make broader use of tools that currently apply only to selected ultra-Orphan therapies. These tools allow...
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...
23:45 , Aug 21, 2018 |  BC Extra  |  Company News

Management tracks: HBP parts ways with Executive Director Chris Ebell

The Human Brain Project (HBP) said Executive Director and Head of the Project Coordination Office Chris Ebell has resigned "following a change of university leadership and differences of opinion on governance and on strategic orientations...
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...
19:56 , Aug 10, 2018 |  BC Extra  |  Company News

Management tracks: Oncopeptides, Merz

Cancer company Oncopeptides AB (SSE:ONCO) said CFO Birgitta Ståhl has stepped down. She is succeeded by Anders Martin-Löf, effective November. He was CFO at medical software company RaySearch Laboratories AB (Stockholm, Sweden) as well as...
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...
22:41 , Jul 30, 2018 |  BC Extra  |  Company News

Management Tracks: Abeona, BioDelivery

Gene therapy play Abeona Therapeutics Inc. (NASDAQ:ABEO) hired Max Colao as chief commercial officer. He was SVP of U.S. commercial operations at Alexion Pharmaceuticals Inc. (NASDAQ:ALXN). Allergy company DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) hired Kevin Trapp...
21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
23:37 , Jul 20, 2018 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 18 profitable biotechs and pharmas are slated to report earnings this week. (A) Six-month EPS figures; (B) Fiscal 1Q CompanyDatePre/post mkt2Q18 EPS est2Q17 EPSExpected chgBiogen Inc. (NASDAQ:BIIB)7/24Pre$5.24$5.044%Eli Lilly and Co. (NYSE:LLY)7/24Pre$1.30$1.1117%Gilead Sciences...