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Infectious Diseases

Bayer’s Phase 3 Trial Of Nifurtimox in Pediatric Patients with Chagas Disease Meets Primary Endpoint

WHIPPANY, N.J., March 14, 2019 /PRNewswire/ — Bayer presented results today from the CHICO part (CHagas disease In Children treated with NifurtimOx) of the phase III clinical study of investigational nifurtimox in pediatric patients with Chagas disease at the “XV Taller sobre la enfermedad de Chagas” conference in Barcelona, Spain. …

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AbCellera Signs Agreement with Global Health Foundation to Fight Infectious Disease

VANCOUVER, British Columbia–(BUSINESS WIRE)–AbCellera today announced a two-year agreement with the Bill & Melinda Gates Foundation to help accelerate global health research. The funding, totaling $4.8 M, will support a series of scientific collaborations between AbCellera and Gates Foundation-funded scientists working on the prevention and treatment of high-priority infectious diseases. The …

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Spero Therapeutics Receives QIDP Designation from the FDA for the Development of SPR720 in Non-Tuberculous Mycobacterial and Lung Infections

CAMBRIDGE, Mass., Feb. 26, 2019 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, announced today that SPR720, an orally administered antimicrobial agent being developed for the treatment of non-tuberculous mycobacterial (NTM) infections, has been granted Qualified …

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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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