FDA Grants wilate Orphan Drug Exclusivity

The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for Octapharma’s wilate, von Willebrand factor/coagulation factor VIII complex (human) lyophilized powder for solution for intravenous injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease (VWD).

Nasal COVID-19 Vaccine Trial Opens

A Phase I clinical trial testing the safety of an experimental nasal vaccine, MPV/S-2P, that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States.

New Pneumococcal Vaccine CAPVAXIVE Approved by FDA

The U.S. Food and Drug Administration has approved CAPVAXIVE for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae in individuals 18 years of age and older.

FDA Approves Yimmugo, an IVIG Product, to Treat Primary Immunodeficiencies

Biotest has received approval from the U.S. Food and Drug Administration for Yimmug to treat primary immunodeficiencies in patients 2 years and older.

New Rule Expands Access to Health Information and Improves Prior Authorization Process

CMS finalized the CMS Interoperability and Prior Authorization Final Rule to improve the electronic exchange of health information and prior authorization processes for medical items and services.

Albumin Administration Superior to Ringer’s Lactate for Maintaining Normovolemia During Major Surgical Hemorrhage

Investigators at the Bern University Hospital conducted a single-center randomized clinical trial to quantify and compare the PVE properties of iso-oncotic 5% albumin, hyper-oncotic 20% albumin and Ringer’s lactate (RL) in patients undergoing radical cystectomy.

Emicizumab Prophylaxis Efficacious and Well-Tolerated in Infants with Severe Hemophilia A Without Inhibitors

The Phase IIIb study of emicizumab shows promise for reducing risk of spontaneous and traumatic bleeds in infants with hemophilia A.

Discovery Could Predict Immunotherapy Response in Melanoma

Researchers have discovered a rare type of immune cell that may predict how likely some patients with skin cancer will respond to immunotherapy treatment.

Researchers Identify an Immune Cell That Can Attack Cancer

Researchers at City of Hope have discovered that a type of immune cell in the human body known to be important for allergy and other immune responses can also attack cancer.

Study Uses Flu Virus to Speed Up COVID-19 Antibodies

A new vaccine may help speed up the process of making antibodies against SARS-CoV-2 by using preexisting immunity to a separate virus (the influenza virus).