Bio-Rad Laboratories snagged FDA approval for its next-generation HIV Ag-Ab test for early detection of the virus. The Hercules, CA-based company's BioPlex 2200 HIV Ag-Ab assay distinguishes between HIV-1 and HIV-2 markers in human blood samples, making it the first diagnostic approved by the agency that can differentiate the infections.
Diagnostic assays that usually require a desktop reader that costs several thousand dollars can now be done using a 3-D printed plate that attaches to a smartphone. Even better, the accuracy of the results achieved are comparable to standard laboratory equipment.
Swedish biotech outfit Cavidi snagged a €10 million ($11 million) loan from the European Investment Bank to develop its next-generation automated testing device for HIV.
The search for an HIV vaccine has been long and difficult, but researchers from Johnson & Johnson, Harvard and other groups may have made a leap. J&J's Janssen reported encouraging results Thursday from its preclinical trial of an HIV vaccine in rhesus monkeys. Encouraging enough for the company to sponsor human studies--the first time a Big Pharma is doing so in the HIV space.
A team of collaborators drawn from Harvard, Johnson & Johnson and other groups published results from a preclinical animal study Thursday afternoon that underscores the potential for developing the world's first HIV vaccine.
The Centers for Disease Control and Prevention says that a formulation of Endo's pain med, Opana ER--that's supposed to be difficult to crush--is responsible for an outbreak of HIV in southern Indiana, because the changes made it easier to prepare the drug for more dangerous intravenous or subcutaneous injection.
India's Cipla recently got FDA approval for a pediatric formulation of the combo drug lopinavir/ritonavir to treat HIV/AIDS in the developing world, but not in the U.S., where market exclusivity rules apply.
U.S. federal health officials said patients should take antiretroviral meds as soon as they are diagnosed instead of waiting to start therapy, potentially opening the door for increased sales of the drugs.
India's Aurobindo Pharma has submitted an abbreviated new drug application (ANDA) to the FDA for the treatment of HIV as part of the country's pharmaceutical industry's efforts to ramp up production of drugs to treat HIV/AIDS.
After getting started 9 years ago with backing from angel investors, Calimmune just landed a $15 million B round, positioning the biotech to move into the clinic with a gene therapy designed to durably stymie the lethal HIV with one treatment.