News

FDA has granted CLIA waiver for the Alere i Strep A test. The test, which was cleared for marketing by FDA in April 2015, is the first molecular platform that detects Group A Streptococcus (GAS) bacteria in 8 minutes or less.

The current global Parkinson’s disease market is characterized by a number of unmet needs, which include addressing the motor complications of dyskinesia and off-episodes. The recent approval of novel therapies and reformulations of existing drugs has the potential to fulfill some of these unmet needs, particularly in patients with advanced disease.

Patients with moderate to severe atopic dermatitis (AD)-or eczema-may be successfully treated using a rheumatoid arthritis (RA) drug recently shown to reverse 2 other skin conditions, vitiligo and alopecia areata, according to findings published early online in the Journal of the American Academy of Dermatology.

On July 7, the FDA updated its list of drugs that are in short supply. Some of the drugs – such as Sodium Chloride 0.9 percent Injection Bags – have been in short supply for months, while others have become more problematic recently.

The FDA last week approved Rexulti (brexpiprazole) for schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).

Major safety concerns exist for many top-selling prescription drugs including benzodiazepines/prescription sleep aids, anticoagulants, cholesterol-lowering statins, oxycodone and hydrocodone, and stimulants. The following provides an overview of these classes and issues.

FDA’s approval last week of AstraZeneca's Iressa (gefitinib) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) is an important tool in fighting the disease.

FDA approved Ipsen Biopharmaceuticals’ supplemental Biologics License Application (sBLA) for abobotulinumtoxinA (Dysport) for the treatment of upper limb spasticity (ULS).

The U.S. Department of Health and Human Services (HHS) will investigate how much money Medicaid has lost over the past decade paying for rising generic drug prices by comparing price increases between 2005 and 2014 against the rate of inflation.

The Healthcare Supply Chain Association (HSCA), the Generic Pharmaceutical Association (GPhA), and other healthcare stakeholders are calling on FDA to institute a clear policy for biologics and biosimilars.

Reducing hospital-acquired infections has become a top priority for hospitals in the face of new penalties from CMS.