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Infectious Diseases

AbCellera and Gilead Enter Infectious Disease Therapeutic Antibody Discovery Collaboration

VANCOUVER, British Columbia–(BUSINESS WIRE)–AbCellera, a leader in therapeutic antibody discovery from natural immune systems, today announced it has entered into an agreement with Gilead Sciences to support the discovery of therapeutic antibody candidates for infectious diseases. AbCellera will apply its expertise in single-cell screening of natural immune sources to generate …

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FDA Approves Merck’s Zerbaxa 3g Dose for the Treatment of Adults with Hospital-Acquired Pneumonia

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Merck’s supplemental New Drug Application (sNDA) for the use of ZERBAXA® (ceftolozane and tazobactam) for the treatment of patients 18 years and older with hospital-acquired bacterial …

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FDA Grants Breakthrough Therapy Designation to La Jolla Pharmaceutical’s Investigational Treatment for Severe Malaria

SAN DIEGO, April 24, 2019 (GLOBE NEWSWIRE) — La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for …

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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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