18:55 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Genentech's flu therapy meets in second Phase III

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said baloxavir marboxil met the primary endpoint of reducing time to improvement of symptoms vs. placebo in the double-blind Phase III CAPSTONE-2 trial to treat influenza virus...
18:16 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

Priority Review for Genentech's flu therapy

Genentech Inc. said FDA accepted and granted Priority Review to its NDA for baloxavir marboxil (RG6152, S-033188) to treat acute uncomplicated influenza in patients ages 12 and older. Its PDUFA date is Dec. 24. The Roche...
14:42 , Jun 26, 2018 |  BC Extra  |  Company News

Priority Review for Genentech's flu therapy

Genentech Inc. said FDA accepted and granted Priority Review to its NDA for baloxavir marboxil to treat acute uncomplicated influenza in patients ages 12 and older. Its PDUFA date is Dec. 24. The Roche (SIX:ROG; OTCQX:RHHBY)...
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...
21:11 , Apr 17, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Influenza virus Mouse studies suggest mAbs against influenza A virus neuraminidase subtypes N1 or N2 could help prevent or treat influenza. In mouse challenge models of lethal H3N2 and H1N1 influenza infection, pre-challenge treatment with...
15:04 , Apr 9, 2018 |  BC Extra  |  Preclinical News

Targeting neuraminidase could improve flu vaccine

A paper in Cell proposes a new strategy to develop an influenza vaccine exploiting the less targeted surface glycoprotein neuraminidase. Efforts to produce effective influenza vaccines have mainly focused on inhibiting hemagglutinin, the more abundant of...
18:40 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

Shionogic gets Japanese approval for flu vaccine

Shionogi & Co. Ltd. (Tokyo:4507) said Japan's Ministry of Health, Labour and Welfare (MHLW) approved an NDA for Xofluza baloxavir marboxil (S-033188), the company's single-dose oral therapy to treat influenza types A and B. The...
22:43 , Mar 1, 2018 |  BC Week In Review  |  Clinical News

CHMP backs approval of BioCryst's Alpivab

EMA's CHMP recommended approval of Alpivab peramivir from BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) to treat uncomplicated influenza. The injectable formulation of viral neuraminidase inhibitor is approved in the U.S. as Rapivab. BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX), Durham, N.C.  Product:...
00:15 , Feb 24, 2018 |  BC Extra  |  Company News

CHMP backs approval of Mylotarg, Alpivab, Kineret

EMA's CHMP announced a spate of opinions Friday, including positive recommendations for Mylotarg gemtuzumab ozogamicin, Alpivab peramivir and Kineret anakinra, as well as the expected negative opinion for Nerlynx neratinib. The committee recommended approval of Mylotarg...