21:01 , Aug 2, 2019 |  BioCentury  |  Regulation

FDA revamps NDA process to get top problems to sponsors faster

FDA has two primary goals in its overhaul of the NDA process. The first is to find the show-stopping issues sooner and put that information in sponsor’s hands. The second is to create more time...
22:41 , Jul 10, 2019 |  BC Extra  |  Clinical News

July 10 Clinical Quick Takes: Darzalex quad combo raises MM complete response, plus Geneos and ViiV

Adding Darzalex improves MM complete response rate in Phase II  Genmab A/S (CSE:GEN; Pink:GMXAY) said Darzalex daratumumab in combination with Revlimid lenalidomide, Velcade bortezomib and dexamethasone met the primary endpoint in the Phase II GRIFFIN...
20:27 , Jul 3, 2019 |  BC Extra  |  Company News

July 3 Company Quick Takes: Dovato approved in Europe for HIV; plus Alexion, RedHill and Insys

EC approves Dovato for HIV The European Commission approved once-daily Dovato dolutegravir/lamivudine from ViiV Healthcare Ltd. (Brentford, U.K.) to treat HIV-1 infection in adults and adolescents above 12 years of age. Third approval for Ultomiris...
01:58 , Jun 29, 2019 |  BioCentury  |  Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
21:05 , Jun 20, 2019 |  BC Extra  |  Company News

Beyond Keytruda: Merck details plans for future growth

Merck is looking beyond its blockbuster cancer drug Keytruda pembrolizumab to late-stage programs in infectious disease, vaccines and chronic indications to help the pharma weather any revenue shortcomings when its diabetes drug Januvia sitagliptin comes...
22:52 , Apr 26, 2019 |  BC Extra  |  Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...
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...
17:44 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

ViiV planning submissions this year for two-drug HIV regimen

ViiV said it plans to submit regulatory applications this year for a once-monthly two-drug regimen comprising cabotegravir and Johnson & Johnson's Edurant rilpivirine to treat HIV-1 infection. ViiV Healthcare Ltd. (Brentford, U.K.) disclosed its plans...
19:55 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

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

ViiV Healthcare Ltd. (Brentford, U.K.) said a once-monthly two-drug regimen comprising cabotegravir and Edurant rilpivirine met the primary endpoint in the Phase III FLAIR trial as maintenance treatment in HIV-1-infected, antiretroviral therapy-naïve patients who are...
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...