Drugs and Devices

July 2017 Vol. 12 No. 7

August 3, 2017 – The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis . . .

July 2017 Vol. 12 No. 7

August 3, 2017 – The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.

cGVHD . . .

July 2017 Vol. 12 No. 7

Protecting American Families: Comprehensive Approach to Nicotine and Tobacco

Remarks by Scott Gottlieb, M.D. / Commissioner of Food and Drug Administration
July 28, 2017 / White Oak, MD

Tobacco use remains the leading cause of preventable disease and death in the United States. But much has changed in the landscape of . . .

July 2017 Vol. 12 No. 7

On July 20, the U.S. Food and Drug Administration (FDA) cleared Embrace Neonatal MRI System, the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units. Read more . . .

July 2017 Vol. 12 No. 7

On July 18, the U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a . . .

July 2017 Vol. 12 No. 7

On July 7, the U.S. Food and Drug Administration (FDA) approved Endari (L-glutamine oral powder) for patients age 5 years and older with sickle cell disease to reduce severe complications associated with the disorder. Read more . . .

June 2017 Vol. 12 No. 6

Going from an occasional user of marijuana to a weekly or daily user increases an adolescent’s risk of having recurrent psychotic-like experiences by 159%, according to a study in the Journal of Child Psychology and Psychiatry. Read more . . .

June 2017 Vol. 12 No. 6

On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce alopecia during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. Read more . . .

June 2017 Vol. 12 No. 6

Researchers have developed a rapid screening method to identify beneficial pairs of existing FDA-approved drugs to combat multi-drug resistant bacterial infections, according to a study in PLoS Biology. Read more and access the study . . .

June 2017 Vol. 12 No. 6

On June 13, the U.S. Food and Drug Administration (FDA) announce new steps it is taking to address opioid addiction.
Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead . . .

June 2017 Vol. 12 No. 6

Use of statins is associated with a higher risk for Parkinson’s disease, according to a study in Movement Disorders. 
Objective
Using a large U.S. claims database (MarketScan), we investigated the controversy surrounding the role of statins in Parkinson’s disease (PD).

Statins may facilitate Parkinson’s disease: Insight . . .

June 2017 Vol. 12 No. 6

Expanded use approval relies on real world evidence

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death . . .

May 2017 Vol. 12 No. 5

On May 30, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Read more . . .