Formulary Watch |

Adoption of fast-growing biosimilars segment essential

Given the spending growth projections for biologics, successful managed care organizations must find a way to ensure appropriate adoption of biosimilars, according to a study published in Health Affairs’ February issue.

Study: Too many heart failure patients are treated with IV fluids

Many patients hospitalized with severe heart failure are receiving potentially harmful treatment with intravenous fluids, according to a Yale-led study, published in the Journal of the American College of Cardiology (JACC): Heart Failure

FDA approves new formulation of Zohydro ER with BeadTek

FDA has approved a new formulation of Zohydro ER (Zogenix) with BeadTek.

FDA approves combined drug to improve glycemic control in diabetes patients

The first-in-class combined medication for improving glycemic control in adults with type 2 diabetes has been approved by FDA.

FDA drug approvals-February 2015

FDA actions in brief, priority review, breakthrough designations, orphan drug designations

How to develop drug formularies for pain treatment in women of reproductive age

More than one-third of reproductive-aged women enrolled in Medicaid, and more than a quarter of those with private insurance, filled a prescription for an opioid pain medication each year during 2008 to 2012, according to a recent report in Morbidity and Mortality Weekly Report (MMWR).

First binge eating disorder drug approved

FDA approved lisdexamfetamine dimesylate (Vyvanse, Shire) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week.

Statin treatment reduces risk of cardiovascular disease in women

Statin treatment reduces the risk of cardiovascular disease in women, according to a large international study, published in The Lancet.

Once-daily opioid formulated with abuse-deterrent properties now available

Hydrocodone bitartrate (Hysingla ER, Purdue Pharma) extended-release tablets CII is now commercially available.

Antiretroviral combination tablet approved for treatment of HIV-1

FDA has approved the antiretroviral Prezcobix (darunavir 800 mg/cobicistat 150 mg, Janssen Therapeutics) for the treatment of human immunodeficiency virus 1 (HIV-1).

FDA expands approved use of Imbruvica for rare form of non-Hodgkin lymphoma

FDA has approved expanded use of ibrutinib for the treatment of Waldenstroms Macroglobulinemia.

FDA speeds up drug, device approvals

FDA's process for approving drugs and devices is speeding up, according to a PricewaterhouseCoopers (PwC) Health Research Institute report.

People's perceptions of drug's cost may affect how much patients benefit

Patients perceptions of drug cost may affect how they benefit from the drug, even when receiving a placebo.

Anticholinergic medications linked to dementia

A large study links a significantly increased risk for developing dementia, including Alzheimers disease, to taking commonly used medications with anticholinergic effects at higher doses or for a longer time, according to a study published in JAMA Internal Medicine. Many older people take these medications, which include nonprescription diphenhydramine (Benadryl).

First mobile system of apps for continuous glucose monitoring approved by FDA

FDA approves new iron replacement drug

FDA approved ferric pyrophosphate citrate (Triferic, Rockwell Medical Inc.) for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

FDA approves first generic version of Nexium

FDA approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules, Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.

FDA approves Natpara injection for hypocalcemia

FDA has approved parathyroid hormone (Natpara, NPS Pharma) once-daily injection to control hypocalcemia in patients with hypoparathyroidism.

[BLOG]: Potential impact of novel pipeline therapies entering the uncharted celiac disease market

Celiac disease occurs due to a genetic intolerance to dietary ingested gluten peptides. This initiates an immune response, predominantly in the small bowel, that results in malabsorption and associated symptoms including chronic diarrhea with weight loss, steatorrhea, postprandial abdominal pain, and bloating.

Study evaluates use of novel oral anticoagulants in ICU

Approximately one-third of patients on a novel oral anticoagulant (NOAC) received inappropriate dosing based on indication, renal function, or concomitant interacting medications during hospitalization in the intensive care unit, typically for stroke prevention in atrial fibrillation, according to data presented at the Society of Critical Care Medicine meeting in Phoenix.

Study assesses best treatments to use when a migraine attack occurs

It is important to ensure established migraine medications are available for the patients who need them, according to a new study published in the January issue of Headache.

FDA approves secukinumab for moderate-to-severe plaque psoriasis

FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of moderate-to-severe plaque psoriasis.

Drug adherence low for patients new to diabetes therapy

Many studies have shown that nonadherence to medications is associated with numerous adverse outcomes (including hospitalizations, higher costs, and increased mortality).

Simulated IV saline products under FDA investigation

FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals.

Americans at risk for alcohol-drug interactions

Healthcare providers need to help patients understand how alcohol can interact with their medications, according to a study from the National Institutes of Health and published in the February 2015 issue of Alcoholism: Clinical and Experimental Research.

FDA approves renal therapy solution

FDA approved Phoxillum Renal Replacement Solutions.

[BLOG]: Why the diabetes paradigm is being questioned

With a few keystrokes, national diabetes organizations declared millions of individuals in the United States as prediabetic by changing the criteria for the disease risk. At the same time, FDA approved 30 new diabetes drugs, allowing their introduction into the market with no rigorous proof that treatment with any of the new agents improved lives.

[BLOG]: Biosimilar confusion and insights

Since Virginia became the first state in May 2013 to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug, there has not been much activity or clarity on the issue.

[BLOG] Pipeline advancement responsible for upturn in global pharma R&D

The world’s leading 30 pharmaceutical companies spent a combined $112 billion on research and development (R&D) in 2013, an increase of $723 million over the previous year. According to our new Global Pharmaceutical Benchmark Report, Roche was the R&D spending leader, outlaying nearly $10 billion in 2013. Meanwhile, Novartis and Johnson & Johnson (J&J) increased their R&D spend the most between 2012 and 2013, with each adding around $500 million to their respective clinics. Novartis’ R&D spending grew by 5.6% to $9.8 billion, and J&J spent $8.2 billion, which was up by 6.8% from 2012.

FDA approves new obesity device

FDA approved the Maestro Rechargeable System, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.