BioCentury | May 19, 2020
Product Development

May 18 Quick Takes: ChemoCentryx’s Phase II miss; plus Teva, Zai-Novocure, Lava-J&J, Sanofi, Rhythm, ViiV

ChemoCentryx therapy fails Phase II study in rare renal disorder  ChemoCentryx Inc. (NASDAQ:CCXI) and partner Vifor Fresenius Medical Care Renal Pharma said CCX140 failed to meaningfully reduce proteinuria vs. control in a Phase II study...
BC Extra | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...
BC Extra | Jul 30, 2019
Company News

July 29 Company Quick Takes: Dupixent sales boost Sanofi; plus Twist, J&J, Alkermes and more

Despite multibillion dollar impairment, Sanofi beats on 2Q19 earnings  Sanofi (Euronext:SAN; NASDAQ:SNY) reported 2Q19 sales of €496 million from dermatitis and asthma drug Dupixent dupilumab, beating the Street's estimate of €411 million. The pharma also...
BC Extra | Apr 29, 2019
Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

Takeda considering value-based pricing in EU  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) is mulling employing a value-based pricing model in Europe for Alofisel darvadstrocel, a stem cell therapy to treat complex perianal fistulas in patients...
BC Extra | Mar 19, 2019
Politics & Policy

FDA issues guidances for long-acting PrEP, pediatric HIV drug development

FDA released final versions of two guidances Tuesday aimed at developing drugs for pediatric HIV patients and for pre-exposure prophylaxis (PrEP), which HHS Secretary Alex Azar said was in line with the Trump administration's HIV...
BC Week In Review | Mar 15, 2019
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...
BC Week In Review | Nov 2, 2018
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...
BC Week In Review | Aug 17, 2018
Clinical News

J&J, ViiV's two-drug regimen meets in Phase III for maintenance treatment of HIV-1 infection

ViiV Healthcare Ltd. (Brentford, U.K.) and Johnson & Johnson (NYSE:JNJ) said a two-drug regimen comprising cabotegravir and Edurant rilpivirine met the primary endpoint in the Phase III ATLAS trial as maintenance treatment in HIV-1-infected adults...
BC Innovations | Jan 23, 2018
Distillery Techniques

Drug delivery

TECHNOLOGY: Other A gastric-resident method of delivering multiple antiretroviral (ART) agents together could treat HIV for prolonged periods with a single administration. The gastric-resident dosage form comprises six rigid arms allowing for the delivery of...
BC Week In Review | Dec 30, 2016
Clinical News

Long-acting intramuscular cabotegravir: Ph III HPTN 083 started

ViiV began the 3-step, double-blind, international Phase III HPTN 083 trial to compare 600 mg long-acting intramuscular cabotegravir vs. once-daily oral Truvada tenofovir disoproxil fumarate/emtricitabine in 4,500 men and transgender women who have sex with...
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