News

Accelerated approval has been granted by FDA to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients who have unresectable or metastatic melanoma not responding to treatment with other drugs.

According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.

Despite known risks of confusion and falls associated with benzodiazepine use in elderly patients, a study published in JAMA Psychiatry, finds that prescription of benzodiazepines increases as people age. The research offers the first estimates of use patterns in the United States.

One medical center is urging parents to seek non-medical solutions for their children’s anxiety or insomnia, after a recent study found that teens prescribed anti-anxiety or sleep medications are up to 12 times more likely to abuse prescription drugs than those who had never been prescribed them.

The Southeastern Pennsylvania Transportation Authority (SEPTA) recently filed a class action suit in federal court against Gilead Sciences, Inc. over the high cost of its hepatitis C drug, Sovaldi.

FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.

More than half of all Medicaid beneficiaries nationwide were enrolled in a managed care organization as of September 2014, according to a new analysis by the Kaiser Family Fund.

FDA has approved olaparib (Lynparza, AstraZeneca) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes, as determined by an FDA-approved test.

FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).

The number of states deciding to pursue some form of Medicaid expansion continues to grow, with Alabama, Alaska, Florida, Tennessee and Wyoming moving forward or indicating intent to pursue an alternative plan.

Customers at 7-11 stores who use a bill-paying system will receive information promoting the Affordable Care Act’s open enrollment period on their printed receipts, allowing HHS to reach financially underserved consumers.

A price increase for a popular form of the medication, naloxone, threatens the ability of non-profit programs and organizations, including police departments around the country, to provide a medical antidote for drug overdoses.