Infectious Diseases

RedHill Biopharma’s Crohn’s Disease Drug Shows Potential Efficacy in Trial

TEL-AVIV, Israel, June 22, 2016 RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today announced the publication of an article demonstrating the potential …

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Hologic and Grifols’ Zika Virus Assay Granted FDA Emergency Use Authorization

MARLBOROUGH, Mass. and EMERYVILLE, Calif., June 20, 2016 /PRNewswire/ — Hologic, Inc. (NASDAQ: HOLX) and Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS) – market-leading partners committed to blood safety – announced today that the U.S. Food and Drug Administration (FDA) has approved use of the Procleix Zika virus blood …

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Eiger Biopharma Licenses an Investigational HVD Therapy from BMS

PALO ALTO, Calif., April 20, 2016 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) announced today that it has licensed Pegylated Interferon Lambda-1a (“Lambda”), a novel, well-characterized, first in class Type III interferon to be studied as an investigational therapy for hepatitis delta virus (HDV) infection, from Bristol-Myers Squibb.  Lambda has …

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Pfizer Joins the Human Vaccines Project to Help Decode the Immune System

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced it will join the Human Vaccines Project (the Project), a public-private consortium focused on cross-sector collaboration to identify human immune responses associated with optimal vaccine protection. Insights gained will guide the development of potentially improved vaccines against diseases such as influenza, dengue, HIV …

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New Guidelines from the FDA Aim to Prevent Zika Transmission through Tissue, Cell Donation

As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration today issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of …

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FDA Accepts and Grants Priority Review to Allergan’s Avycaz sNDA

DUBLIN, Feb. 24, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam). This filing will add important new clinical data to the current label …

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FDA Accepts Merck’s BLA for Bezlotoxumab in C. difficile Prevention

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 accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence. The FDA granted Priority …

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FDA Approves Bayer’s Avelox for Treatment of Plague

The US Food and Drug Administration (FDA) has cleared Bayer HealthCare Pharmaceuticals’ Avelox (moxifloxacin) for the treatment of pneumonic plague and septicemic plague. The drug is also approved for prevention of plague in adult patients. “Today’s approval provides an additional therapy for the treatment of plague,” said Edward Cox, MD, …

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FDA Approves Astellas’ Cresemba for Rare but Serious Fungal Infections

The US Food and Drug Administration (FDA) has approved Astellas’ new antifungal drug to treat two rare, often fatal invasive fungal infections. The agency approved Astellas’ New Drug Application (NDA) for the use of Cresemba (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in …

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