17:36 , Mar 8, 2019 |  BC Week In Review  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions on March 1, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first...
22:10 , Mar 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions Friday, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first approved antidote...
17:57 , Oct 25, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Coronavirus; influenza virus; HIV/AIDS; Ebola Cell culture and rat studies identified lipopeptide-based inhibitors of MERS-CoV S protein, Ebola virus glycoprotein and HIV env that could help treat Middle East respiratory syndrome coronavirus (MERS-CoV), Ebola...
22:57 , Oct 11, 2018 |  BC Week In Review  |  Clinical News

Genentech's flu therapy shortens time to symptom improvement by almost 30 hours in Phase III

Genentech Inc. reported additional data from the Phase III CAPSTONE-2 trial to treat influenza virus infection in patients at high risk of complications showing that baloxavir marboxil led to a median time to improvement of...
21:32 , Sep 19, 2018 |  BC Innovations  |  Translation in Brief

To eat and not to eat

A Nature Communications paper published last month by Forty Seven Inc. (NASDAQ:FTSV) co-founder Irving Weissman and colleagues at Stanford University highlights a new strategy for boosting “eat me” signals on cancer cells that could complement...
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...
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;...
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...
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...