Gilead Sciences Inc. said it expects to have its four-drug, single-tablet regimen Stribild, formerly known as Quad, available to patients by the end of this week, following the drug's approval Monday for treatment-naïve patients with HIV-1 infection.
Gilead Sciences Inc.'s four-drug, single-tablet HIV drug Quad got its much-anticipated approval Monday, and the drug is expected to shore up the firm's top-selling HIV franchise, which brought in $7.05 billion in revenue in 2011 but faces patent expiries starting in 2018.
Over the past two years, the advent of protease inhibitors launched a paradigm shift that is changing the landscape of hepatitis C treatment. Now, 2009 biotech start-up Novira Therapeutics Inc. is looking to foster a similar revolution in hepatitis B, and its capsid-targeting approach got a boost last week with the closing of a $23 million Series A financing.
A robust second quarter, approval of HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for prophylactic use and competitor setbacks that could add to its lead in the race for an all-oral hepatitis C virus regimen all contributed to an impressive summer for Gilead Sciences Inc.
The rat has been a staple in drug research for decades. With well characterized immune systems that are more closely predictive of human conditions, rats make excellent lab testing subjects. But Open Monoclonal Technologies Inc. (OMT), a 2007 start-up based in Palo Alto, Calif., is elevating the rat's role in drug development with a fully human monoclonal antibody platform based on transgenic rats.
Regeneron Inc.'s Zaltrap (ziv-aflibercept) won FDA approval Friday in metastatic colorectal cancer, for use in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy, a little more than a year after surprising investors with positive data in a pivotal trial.
Alkermes plc posted its most impressive quarter so far since last fall's acquisition of Elan Corp. plc's drug delivery unit and relocation of its headquarters to Dublin, Ireland, reporting total revenues of $152.2 million, a 146 percent jump over the same three-month period in 2011.
Alkermes plc posted its most impressive quarter so far since last fall's acquisition of Elan Corp. plc's drug delivery unit and relocation of its headquarters to Dublin, Ireland, reporting total revenues of $152.2 million, a 146 percent jump over the same three-month period in 2011.
Amgen Inc.'s second-quarter figures blasted past expectations, as the Thousand Oaks, Calif.-based firm reported after market close Thursday total revenues of $4.5 billion, with adjusted earnings per share of $1.83, compared to consensus estimates of $4.1 billion and $1.54 per share.
Only days after the first gene therapy finally cleared regulatory hurdles in Europe, Cambridge, Mass.-based gene therapy firm bluebird bio closed a $60 million Series D financing round.
