Children’s National Hospital Rare Disease Institute and Takeda Partner to Standardize Care for Patients With Rare Diseases

The following is an excerpt from a press release from Takeda. Read the press release in its entirety here. Children’s National Hospital and Takeda Pharmaceutical Company Limited announce the creation of the Rare Disease Clinical Activity Protocols (Rare-CAP) program, which will establish a networked system for the development, dissemination and curation of protocols to help […]

FDA Identifies Biomarker for Immune Response to FVIII Products Used to Treat Hemophilia A

The following is a press release from the FDA. Read the press release on the FDA website here. Scientists at the U.S. Food and Drug Administration developed a technique that enables them to determine whether immune system cells called dendritic cells appear primed to trigger the production of antibodies against Factor VIII (FVIII) products used to […]

FDA Issues a MedWatch Safety Alert Regarding Certain Hepatitis C Medications

The following is an excerpt from a FDA MedWatch Safety Alert. Read the full safety announcement here.FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.FDA identified 63 […]

MASAC Issues Safety Information Update on Emicizumab (HEMLIBRA)

The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) has released a safety information update about Emicizumab (Hemlibra), a new subcutaneous treatment for hemophilia A patients with inhibitors. This update has been released following the first report of an anti-drug antibody to Emicizumab. MASAC’s update issues recommendations for providers and patients in case of […]

Hemophilia Puts Damper on Patients’ Sex Life and Health Status, Study Reports

Study Shows Sexual Intimacy Correlates With More Bleeds The following is an excerpt from Hemophilia News Today. Read the entire article here. Researchers report that hemophilia interferes with patients’ sexual activity and is linked to worse health status.The study titled “Sexual Health in Patients with Hemophilia; The Insights from the Patient Reported Outcomes, Burdens and Experiences (PROBE) […]

Voluntary Recall of Pharmacist Choice Alcohol Prep Pads

MedWatch, the FDA safety information and adverse event reporting program released a safety alert on December 5, 2017 outlining a voluntary recall by Simple Diagnostics of three lots of Pharmacist Choice Alcohol Prep Pads due to the lack of sterility assurance and other quality issues. The affected lots are: SD2070421201 (Exp. 12/2019)SD2070420925 (Exp. 09/2019)SD2070420601 (Exp. 12/2019) The full […]

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