16:26 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA wants extra trial for Pharming's Ruconest as HAE Prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20 (20%)...
18:24 , Sep 19, 2018 |  BC Extra  |  Company News

FDA wants extra trial for Pharming's Ruconest as HAE prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20 (20%)...
19:06 , Jul 26, 2018 |  BC Innovations  |  Emerging Company Profile

The universe in an exosome

Versatope Therapeutics Inc. is using exosomes from commensal E. coli as the backbone of a universal influenza vaccine that should be cheaper and easier to manufacture than other vesicle-based vaccines. The company’s technology was developed by...
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...