Serum Albumin a Strong Predictor of Mortality in Sepsis: Two New Studies

Two studies suggest low serum albumin levels in patients with sepsis is associated with mortality.
CMS Finalizes Rule on Medicare Advantage Pay Raise Based on Patient Encounter Data

CMS has finalized its rule to give Medicare Advantage plans a 2.53 percent pay raise in 2020, up from its original plan to raise pay 1.59 percent.
New Voluntary Medicare Part D Demo Aims to Reduce Spending on High-Cost Drugs

CMS announced the Part D Payment Modernization Model to share in savings generated by reducing costs in the program’s catastrophic phase.
HHS Grants Awarded to Help Americans Access HIV/AIDS Care and Medication

In 2018, HHS awarded $2.34 billion in Ryan White HIV/AIDS Program grants to cities, counties, states and local community based organizations.
Accelerated Dosing Regimen Approved for Japanese Encephalitis Vaccine

Valneva USA has received FDA approval of an accelerated dosing regimen for IXIARO (Japanese encephalitis vaccine, inactivated, adsorbed).
Nivestym, a Biosimilar to Neupogen, Approved by FDA

Pfizer’s Nivestym (filgrastim-aafi) has been approved by FDA for all eligible indications of the reference product.
Flu Shot Does Not Cause Pregnant Women to Miscarry

A new study conducted by investigators at the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Institute in Wisconsin has found the flu vaccine does not cause miscarriages in pregnant women.
First Cancer Drug for Specific Gene Mutation Gets FDA Approval

FDA has granted accelerated approval to Keytruda (pembrolizumab) for patients whose cancers have a specific genetic feature (biomarker).
New Gene Therapy Treatment Offers Possible Cure for SCID-X1

Researchers at St. Jude Children’s Research Hospital have cured infants with X-linked severe combined immunodeficiency (SCID-X1) using gene therapy involving a re-engineered virus.
Takeda Receives FDA Approval to Manufacture Flexbumin at Georgia Facility

FDA approved Takeda Pharmaceuticals’ second submission for its new plasma manufacturing facility near Covington, Ga.