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...
19:12 , May 18, 2018 |  BC Week In Review  |  Company News

CSL gains exclusive rights to Cevec's CAPGo technology

Cevec Pharmaceuticals GmbH (Cologne, Germany) granted CSL Ltd. (ASX:CSL) exclusive rights to develop and commercialize CAPGo-derived complement 1 (C1) esterase inhibitor proteins for hereditary angioedema (HAE). CSL plans to develop CAPGo-derived proteins with tailored glycosylation, which...
18:58 , May 4, 2018 |  BC Week In Review  |  Clinical News

EC approves BioCryst's Alpivab for influenza

BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) said the European Commission approved an MAA for Alpivab peramivir to treat uncomplicated influenza in patients at least two years old. The injectable formulation of a viral neuraminidase inhibitor is approved in...
19:20 , May 1, 2018 |  BC Extra  |  Company News

EC approves BioCryst's Alpivab for influenza

BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) said the European Commission approved an MAA for Alpivab peramivir to treat uncomplicated influenza in patients at least two years old. The injectable formulation of a viral neuraminidase inhibitor is approved...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
17:59 , Mar 23, 2018 |  BC Week In Review  |  Clinical News

FDA, EMA approve CSL's Hizentra for CIDP

CSL Ltd. (ASX:CSL) subsidiary CSL Behring said FDA and the European Commission have each approved Hizentra human immune globulin as a maintenance treatment to prevent relapse of neuromuscular disability and impairment in patients with chronic...
21:47 , Mar 19, 2018 |  BC Extra  |  Company News

Management tracks: J&J, Alder, CVS

Johnson & Johnson (NYSE:JNJ) said EVP and CFO Dominic Caruso will retire in September. He is succeeded by VP of investor relations Joseph Wolk. Alder BioPharmaceuticals Inc. (NASDAQ:ALDR) said President and CEO Randall Schatzman will step...
20:58 , Mar 16, 2018 |  BC Extra  |  Company News

CSL's Hizentra gains approvals for rare disease CIDP

CSL Ltd. (ASX:CSL) subsidiary CSL Behring said FDA and the European Commission have each approved Hizentra human immune globulin as a maintenance treatment to prevent relapse of neuromuscular disability and impairment in patients with chronic...
21:02 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

Priority review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26. The...
22:09 , Feb 23, 2018 |  BC Extra  |  Company News

Priority Review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26. The...