Formulary Watch |

[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.

Pharmacist counters CDC antivirals for flu alert

The Centers for Disease Control’s new guidance that hospitalized and high-risk patients with unconfirmed but suspected flu should be administered anti-virals without waiting may cause additional medication shortages, according to a pharmacist and professor.

FDA approves Signifor LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder

FDA has approved long-acting release (LAR) pasireotide (Signifor, Novartis) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

[BLOG]: A better IV compounding strategy: Leveraging in-house advantage

It’s no secret that the compounding industry is under greater scrutiny these days. A number of high-profile cases, including recent deaths linked to outsourced intravenous (IV) compounding at a Texas hospital, have moved patient safety concerns front and center.1 In the wake of ongoing fallout and a 2-year crackdown on compounding centers by FDA, many hospitals are analyzing their current strategy and rethinking the pros and cons of outsourced IV compounding.

FDA approves Gadavist for pediatric patients younger than 2

FDA has approved gadobutrol (Gadavist, Bayer HealthCare) injection for use with magnetic resonance imaging (MRI) in pediatric patients aged younger than 2 years to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. It is the first gadolinium-based contrast agent for patients aged younger than 2 years, including term neonates

Overall survival extended in afatinib-treated patients with specific lung cancer mutations

Afatinib extends overall survival in lung cancer patients whose tumors have the most common epidermal growth factor receptor (EGFR) mutation compared with chemotherapy, according to study results published in The Lancet Oncology from 2 independent phase 3 clinical trials in EGFR mutation-positive patients with metastatic non-small cell lung cancer (NSCLC).

FDA OKs carbidopa/levodopa enteral suspension for Parkinson's

FDA has approved carbidopa-levodopa (Duopa, AbbVie) enteral suspension for the treatment of patients with advanced Parkinson’s disease.

Pharmacologic treatment of prostate cancer

Prostate cancer is the most frequently diagnosed cancer, aside from non-melanoma skin cancer, in men in the United States. According to the American Cancer Society, an estimated 233,000 new cases of prostate cancer and an estimated 29,480 deaths from prostate cancer will have occurred in the United States during 2014. About 60% of all prostate cancer cases are diagnosed in men aged 65 years and older, and 97% of cases occur in men aged 50 and older. The incidence of prostate cancer is 60% higher in African Americans than in whites.

FDA defers to docs in use of pain therapies for pregnant women

In a drug safety communication, FDA said that it is aware of recent reports questioning the safety of prescription and over-the-counter (OTC) pain drugs when used during pregnancy, but that it lacks adequate studies to change current recommendations.

Factor Xa inhibitor approved to reduce stroke risk in AF patients

The factor Xa inhibitor edoxaban (Savaysa, Daiichi Sankyo) has been approved by FDA to lower the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

FDA approves Gazyva sBLA with new data in previously untreated CLL

FDA approved a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva, Genentech, a member of the Roche Group) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL).

FDA approves Rytary for Parkinson’s disease

FDA approved an extended-release oral capsule formulation of carbidopa-levodopa (Rytary, Impax Pharmaceuticals, a division of Impax Laboratories, Inc.) for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.

Cancer biosimilar drug deemed similar to Neupogen

Novartis AG’s biosimilar cancer drug, EP2006, is “highly similar” to Amgen’s blockbuster cancer drug, Neupogen, FDA staff said in a new report.

2014 drug costs soar, no end in sight

While hepatitis C drugs Solvani, Harvoni, and Viekira Pak have been in the news recently because of their high price tag, and Express Scripts’ and CVS Health’s exclusive agreements with the drugmakers, they are not the only culprits in soaring drug costs.

CVS Health commits to Gilead's hepatitis C drugs

Close on the heels of Express Scripts’ decision to make AbbVie’s Viekira the exclusive hepatitis C treatment in its formulary, CVS Health said it would make Gilead Sciences’ Harvoni and Sovaldi the exclusive option for patients on its commercial drug list, as well as those on Medicare Part D and Medicaid.

FDA grants waiver for influenza test

FDA this week granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. Previously, the test was only available for use in certain laboratories, and now can be distributed to emergency rooms, health department clinics, physicians’ offices, and other healthcare facilities.

Study: ACA will reduce costs for many

The share of Americans with high medical costs increased prior to the implementation of the Affordable Care Act, according to a new report from The Commonwealth Fund.

Pharmacies face nationwide Tamiflu shortage

Pharmacies and physicians’ offices across the country are reporting a shortage of Tamiflu to prevent and treat the flu, soon after the Centers for Disease Control (CDC) declared the illness an epidemic. The “epidemic” declaration was made after 21 children died so far this season from complications associated with the flu.

Bladder control drug may help control weight

Mirabegron (Myrbetriq), an oral drug approved by FDA in 2012 for treating incontinence, may help control weight by boosting the metabolic abilities of brown fat, a form of fat that can help to expend energy, according to an early phase clinical study.