Drug to Treat Acute Pancreatitis Granted Fast Track Designation by FDA

Panafina Inc.’s investigational new drug, RABI-767, has been granted fast track designation by the U.S. Food and Drug Administration (FDA) to treat patients with acute pancreatitis predicted to progress to severe disease.
Study Shows Vaccination Decision in IEI Patients Must Be Individualized

Inborn errors of immunity (IEI) increase morbidity and mortality risks, particularly from respiratory tract infections. Hence, vaccination becomes pivotal for IEI patients.
Immune Globulin and Prophylactic Antibiotics Provide Similar Efficacy in Treating Hypogammaglobulinemia Secondary to Hematological Malignancy

Immune globulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared.
New Study to Examine COVID-19 Vaccines in People with Weakened Immune Systems

Researchers at the University of Wisconsin (UW) School of Medicine and Public Health are exploring the ideal vaccine booster strategy for immunosuppressed patients to protect those at higher risk of severe illness and complications from COVID-19 infection.
New Vaccine Could Lower ‘Bad’ Cholesterol by as Much as 30 Percent

A new vaccine currently in development can effectively and affordably lower levels of “bad’ cholesterol in the body, a health problem that affects almost two in five adults in the U.S.
CSL Behring Adds 4 and 5 Gram Vials of ZEMAIRA

CSL Behring’s ZEMAIRA (alpha1- proteinase inhibitor [human]) is now available in 4 gram and 5 gram vials.
World’s First Gene Therapies Approved to Treat Sickle Cell Disease

The U.S. Food and Drug Administration has approved two treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease in patients 12 years and older.
FDA Approves Repotrectinib for Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s repotrectinib (Augtryo) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Fresenius Kabi’s Tyenne, a Biosimilar of Actemra, Is Approved to Treat Autoimmune Diseases

The U.S. Food and Drug Administration has approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), to treat multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis.
Hizentra Vials to Be Discontinued and Replaced with Prefilled Syringes

CSL Behring is discontinuing all sizes of Hizentra vials in the U.S. by the end of September 2024.