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An approval by the US Food and Drug Administration later this month for Protalix/Pfizer's plant-derived human therapeutic protein taliglucerase alfa would mark a first for 'pharmers'.
The US Food and Drug Administration approved slightly fewer new drugs than in recent years, and the industry's focus on specialty-care products continued to shine through.
Abraham Thomas, panellist at three US Food and Drug Administration (FDA) hearings on new potential anti-obesity agents last year, discusses the need for change in the agency's anti-obesity regulatory guidelines.
The Fc (crystallizable fragment) region of therapeutic antibodies can have an important role in their safety and efficacy. This article summarizes the current knowledge of antibody Fc functionality, provides a strategy for assessing the effector functions of different classes of therapeutic antibodies and proposes a path for routine testing and controls for manufacturers of antibody products.
Here, the authors examine the underlying mechanisms that result in cardiotoxicities of small molecule kinase inhibitors, highlight the challenges of making safe and selective kinase inhibitors and discuss how preclinical safety models might be used to predict clinical cardiotoxicity.
Activating mutations in Janus kinase 2 (JAK2) are a common feature of a number of myeloproliferative neoplasms. JAKs are also involved in the pathogenesis of inflammatory and immune-mediated disorders, and several JAK inhibitors are now in clinical development. In this Review, Quintás-Cardama and colleagues discuss the current progress in this field.
Current drugs for osteoporosis primarily prevent bone loss, and there is a substantial need for treatments that could reduce fracture risk further. Rosen and colleagues describe recent insights into skeletal physiology that are providing the basis for novel therapeutics to promote bone formation, and discuss the regulatory and commercial challenges for these agents.
