Results from the Phase III PROLONG9FP ongoing extension clinical development program evaluating the long-term efficacy and safety of IDELVION (coagulation factor IX [recombinant], albumin fusion protein) showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption.
A lung cancer vaccine developed in Cuba has been approved by the U.S. Food and Drug Administration for a clinical trial at Roswell Park Cancer Institute in Buffalo, N.Y.
The U.S. Food and Drug Administration granted orphan drug designation to dusquetide (SGX942, Soligenix) for the treatment of macrophage activation syndrome.
The U.S. Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis) to treat advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.
A randomized Phase III study (ZOE-70) of GlaxoSmithKline’s investigational shingles vaccine, Shingrix, showed 90 percent efficacy in adults aged 70 years and older that is maintained for at least four years.
True North Therapeutics’ TNT009 for the treatment of autoimmune hemolytic anemia, including cold agglutinin disease (CAD), has been granted orphan drug status by the U.S. Food and Drug Administration.
The Centers for Medicare and Medicaid Services has delayed enforcement of a rule that changes the way state Medicaid agencies reimburse pharmacies for prescription drugs.
The U.S. Department of Health and Human Services has awarded $94 million in Affordable Care Act funding to 271 health centers in 45 states, the District of Columbia and Puerto Rico.
The Centers for Medicare and Medicaid Services announced 10 states in four regions in which it will launch its primary care quality improvement initiative.
The National Institutes of Health will spend $260 million over four years to fund four genome sequencing and analysis centers whose research is expected to focus on understanding the genomic bases of common and rare human diseases.
Three health centers in America Samoa and the U.S. Virgin Islands and their 12 delivery sites that served nearly 26,000 patients in 2014, including more than 6,000 women ages 15 years to 45 years, have been awarded $742,000 in funding to fight the Zika virus.
The U.S. Senate approved the Medicare “lock-in” provision that gives Medicare Part D plans the authority to require at-risk beneficiaries to use a single prescriber and pharmacy for frequently abused drugs.
