Thursday , May 25 2017
Home / Infectious Diseases

Infectious Diseases

Quest Diagnostics Launches New HBV Test to Help Assess Response to Antiviral Therapy

MADISON, N.J., Jan. 18, 2017 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced the launch of a new test service that helps physicians evaluate a patient’s response to drug therapies used to treat infection with the hepatitis B virus (HBV). The first …

Read More »

FDA Grants Redhill Biopharma’s Treatment for Nontuberculous Mycobacteria Infections QIDP Fast Track Designation

RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM) Infection Under FDA’s Generating Antibiotic Incentives Now (GAIN) Act, QIDP designation allows for Fast-Track status and Priority Review, potentially leading to a shorter NDA review time by the FDA, …

Read More »

FDA Research to Help Speed Development of Zika Virus Vaccines and Therapeutics

A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLoS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies …

Read More »

FDA Approves Gilead’s Vemlidy for Treatment of Hepatitis B

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Vemlidy has a boxed warning in its product label …

Read More »

Scientists Uncover New Facets of Zika-Related Birth Defects

JUPITER, FL – Oct. 17, 2016 – In a study that could one day help eliminate the tragic birth defects caused by Zika virus, scientists from the Florida campus of The Scripps Research Institute (TSRI) have elucidated how the virus attacks the brains of newborns, information that could accelerate the …

Read More »

Takeda to Develop Zika Vaccine with up to $312 Million in Funding from US Government

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda’s Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world. Initial funding from BARDA, which is …

Read More »

FDA Advises Testing for Zika Virus in all Donated Blood and Blood Components in the US

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories. “There is still much uncertainty regarding the nature and …

Read More »

Special Report Documents Zika Virus’ Impact on the Fetal Brain

BOSTON – In a special report released August 23 in the journal Radiology, a team of researchers including Deborah Levine, MD, Director of Obstetric & Gynecologic ultrasound at Beth Israel Deaconess Medical Center (BIDMC) and professor of radiology at Harvard Medical School (HMS), documented the brain abnormalities associated with congenital …

Read More »

Xenetic Biosciences Partners with Excivion for Development of Novel Combined Zika and Dengue Vaccine

LEXINGTON, Mass.–(BUSINESS WIRE)–Xenetic Biosciences, Inc. (OTCQB: XBIO) (“Xenetic” or the “Company”), a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, today announced that it has commenced a collaboration with Excivion Ltd. (“Excivion”) to develop a vaccine against Zika and dengue viruses. As part of the collaboration, Xenetic’s …

Read More »

FDA Approves Cephed’s Carba-R Assay to Test for Genetic Markers of Drug-Resistant Bacteria

SUNNYVALE, Calif., June 30, 2016 /PRNewswire/– Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, the first FDA-cleared test for detection of carbapenem resistance genes of multidrug resistant ‘superbugs’.  Following initial clearance in March for …

Read More »