Current CMS Biosimilars Reimbursement Policy Outlined
The Centers for Medicare and Medicaid Services has published several policies on biosimilars reimbursement.
ProMetic Completes First Dosing in Plasminogen Deficiency Patients
In its Phase I clinical trial, ProMetic Life Sciences successfully completed its first round of IV plasminogen dosing in plasminogen deficiency patients.
Biomarker Found in CIDP Patients Who Don’t Respond to IVIG Therapy
A recent study discovered a biomarker in chronic inflammatory demyelinating polyneuropathy patients that explains why they don’t respond to intravenous immune globulin therapy.
FDA Approves Adynovate to Treat Hemophilia A
The U.S. Food and Drug Administration has approved Baxalta’s Adynovate for use in hemophilia A patients aged 12 years and older.
CMS to Reimburse ICD-10 Mistakes for One Year
In response to concerns by providers about the ICD-9 to ICD-10 coding system, the Centers for Medicare and Medicaid Services says it will reimburse for incorrectly coded claims for one year past the Oct. 1, 2015, deadline.
Engineered Protein Controls Bleeding in Severe VWD
Results of a Phase III study show that BAX 111, a highly purified recombinant von Willebrand factor analog manufactured by Baxalta, appeared safe and effective for treatment of bleeding episodes in patients with severe von Willebrand’s disease.
CMS Creates Site that Lists Drug Use and Spending
The Centers for Medicare and Medicaid Services has created an interactive online dashboard to allow the public and policymakers to explore the financial burden that high-expense drugs place on the Medicare program and the nation’s seniors.
FDA Issues Guidance to Protect Blood Supply from Zika Virus
The U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus or have had a confirmed Zika virus infection.
New Type of Sound Wave May Allow for Inhalable Vaccines
A new form of hybridized sound waves developed by Australian researchers may allow drugs and vaccines to be delivered to the body through a nebulizer in a fine mist inhaled into the lungs.
Cancer-Causing Gene Found in Plasma May Help Predict Outcomes for Patients
University of Cincinnati researchers have discovered that a human cancer-causing gene, called DEK, can be detected in the plasma of head and neck cancer patients.
