16:57 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

FDA approves Shionogi's thrombocytopenia drug

FDA approved Mulpleta lusutrombopag from Shionogi & Co. Ltd. (Tokyo:4507) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Mulpleta is the second drug to receive...
20:40 , Jul 31, 2018 |  BC Extra  |  Company News

FDA approves Shionogi's thrombocytopenia drug

FDA approved Mulpleta lusutrombopag from Shionogi & Co. Ltd. (Tokyo:4507) to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Mulpleta is the second drug to receive...
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...
18:38 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

ViiV presents detailed Phase III primary endpoint data for two-drug HIV regimen

ViiV Healthcare Ltd. (Brentford, U.K.) presented pooled additional data from a pair of Phase III trials in HIV-1 infected patients showing that its two-drug regimen of dolutegravir and lamivudine led to HIV-1 RNA levels of...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
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)...
19:57 , Jun 15, 2018 |  BC Week In Review  |  Company News

Shionogi gains Asian rights to SAGE-217

Shionogi & Co. Ltd. (Tokyo:4507) licensed exclusive rights to SAGE-217 from Sage Therapeutics Inc. (NASDAQ:SAGE) in Japan, Taiwan and South Korea to treat major depressive disorder (MDD). Shionogi will pay Sage $90 million up front, with...
19:29 , Jun 15, 2018 |  BC Week In Review  |  Clinical News

ViiV's two-drug HIV regimen meets in Phase III for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) said its two-drug regimen of dolutegravir and lamivudine met the primary endpoint in a pair of Phase III trials to treat HIV-1 infection in treatment-naïve patients with baseline viral loads...
18:38 , Jun 14, 2018 |  BC Extra  |  Clinical News

ViiV's two-drug HIV regimen meets in Phase III for HIV

ViiV Healthcare Ltd. (Brentford, U.K.) said its two-drug regimen of dolutegravir and lamivudine met the primary endpoint in a pair of Phase III trials to treat HIV-1 infection in treatment-naïve patients with baseline viral loads...