Daktari Diagnostics reeled in another $7 million in equity financing, an amount likely to help fuel the company's overall expansion as well as the construction of a new plant in Scotland for its point-of-care-HIV tests.
Gilead Sciences was in a position to say, "I told you so," when its first quarter earnings fell a little short of Wall Street expectations Thursday. Profits were still up 63% even as sales of older HIV drugs came in shy of forecasts.
Once drugs are approved, manufacturing is supposed to kick in and get the product out the door so drugmakers can start making some money. But recently, questions about manufacturing have not only been a stumbling block for some companies to getting approvals, they have broken up a relationship.
Hangzhou, China-based Ascletis aims to develop the candidate, called TMC310911, as an affordable and superior treatment for HIV patients in China, company CEO Jinzi Wu told FierceBiotech in an interview.
When Gilead Sciences' ($GLD) Truvada was approved as an HIV preventative last year, it was hailed as a historic event. It was the first time an HIV drug had been approved to stave off HIV infection, rather than treat those who had already contracted the virus.
The refusals for elvitegravir and cobicistat on a standalone basis were triggered after inspectors were left shaking their heads following a checkup on Gilead's "documentation and validation of certain quality testing procedures and methods."
The federal government has put the brakes on the largest and most advanced study of a vaccine against HIV infection after an independent data and safety monitoring board found that the vaccine regimen did not benefit patients.
U.K. molecular diagnostics company Lumora will work with the Foundation for Innovative New Diagnostics to develop an assay for malaria, an illness that strikes millions of people in warmer climates around the world.
Technology behind DVD players (does anyone use those any more?) is gaining a second life as the basis for an inexpensive HIV diagnostic test.
Daktari Diagnostics is scaling up its manufacturing presence, planning to spend $15 million to build a plant in Scotland that will manufacture point-of-care HIV tests.