17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...
21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT)...
19:35 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

FDA approves Merck's doravirine HIV therapies

Merck & Co. Inc. (NYSE:MRK) said FDA approved two doravirine-based therapies to treat HIV infection ahead of their Oct. 23 PDUFA date: once-daily Pifeltro doravirine for use in combination with antiretrovirals; and once-daily Delstrigo, a...
23:46 , Aug 8, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Alzheimer’s disease (AD); progressive supranuclear palsy (PSP) Patient sample and fly studies suggest PIWIL1 overexpression or inhibiting viral DNA polymerases could help treat AD, PSP and other tauopathies. In postmortem cortex and cerebellum samples...
16:56 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Merck's doravirine similar to ritonavir-boosted darunavir in Phase III for HIV-1 infection

Merck & Co. Inc. (NYSE:MRK) said once-daily oral doravirine (MK-1439) in combination with other antiretroviral therapies (ARTs) led to viral suppression at week 96 in 73.1% of patients vs. 66% of patients treated with ritonavir-boosted...
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...
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...
19:58 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Gilead's switching to Biktarvy non-inferior in Phase III to treat HIV-1 in women

Gilead Sciences Inc. (NASDAQ:GILD) reported data from the open-label, international Phase III GS-US-380-1961 trial in 470 virologically suppressed adult women with HIV-1 infection showing that switching from either a boosted protease inhibitor or boosted Vitekta...
19:58 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Gilead reports additional Phase III data from HIV switching trial of Biktarvy

Gilead Sciences Inc. (NASDAQ:GILD) reported additional data from the Phase III GS-US-380-1844 trial in 563 virologically suppressed adults with HIV-1 infection showing that switching from either Tivicay dolutegravir plus abacavir/lamivudine or Triumeq dolutegravir/abacavir/lamivudine to once-daily...