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Infectious Diseases

FDA Grants QIDP and Fast Track Designations to Cidara’s Rezafungin Prophylaxis Development Program

SAN DIEGO–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for the company’s prophylaxis (prevention) development program for lead antifungal product candidate, rezafungin …

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BioNTech Enters Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza

MAINZ, Germany & NEW YORK–(BUSINESS WIRE)–BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of …

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FDA Approves Merck’s Prevymis for Prevention of Cytomegalovirus Infection in HSCT Patients

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) …

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FDA Approves Test for Screening Zika Virus in Blood Donations

The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. It is intended for use by blood …

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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 …

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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, …

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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 …

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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 …

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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 …

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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 …

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