18:55 , Apr 12, 2019 |  BC Week In Review  |  Company News

FDA approves ViiV's two-drug HIV regimen

FDA approved Viiv's Dovato dolutegravir/lamivudine for HIV-1 infection in treatment-naïve adults. The product is a once-daily, single-tablet regimen of dolutegravir and lamivudine that the company plans to launch in 2-3 weeks at a wholesale acquisition...
21:14 , Mar 22, 2019 |  BC Week In Review  |  Clinical News

Descovy non-inferior to Truvada for HIV prevention

Gilead reported on March 6 that once-daily Descovy emtricitabine/tenofovir alafenamide met the primary endpoint of non-inferiority to once-daily Truvada emtricitabine/tenofovir in the Phase III DISCOVER trial to prevent HIV infection. Gilead Sciences Inc. (NASDAQ:GILD) said...
13:30 , Feb 13, 2019 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: HIV/AIDS Cell culture studies identified HIV reverse transcriptase inhibitors that could help treat HIV infection resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs). Chemical synthesis of dihydrofuropyrimidine-based NNRTIs and cell-based HIV-1 infectivity assays identified 10...
18:50 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

ViiV seeks FDA approval for two-drug HIV-1 regimen

ViiV Healthcare Ltd. (Brentford, U.K.) said it submitted an NDA to FDA for its single-tablet, two-drug regimen of dolutegravir and lamivudine to treat HIV-1 infection. The company used a Priority Review voucher to speed up...
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...