Formulary Watch |

Study: Prenatal antibiotic use may be linked to obesity risk in offspring

Blincyto to treat lymphoblastic leukemia approved, carries boxed warning

FDA has approved blinatumomab (Blincyto, Amgen) immunotherapy for the treatment of relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia.

[BLOG]: AHA Scientific Sessions 2014: Where do the PCSK9s fit in the post-IMPROVE-IT world? A “modest” proposal

This year, the American Heart Association (AHA) Scientific Sessions were held in Chicago, Illinois, from November 15 to 19. Of all of the late-breaking clinical trials presented at AHA 2014, the IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) study of Merck’s low-density lipoprotein cholesterol (LDL-C)-reducing drugs-the statin, Zocor (simvastatin), and the fixed-dose combination, Vytorin (ezetimibe/simvastatin)-stole the show.

FDA grants breakthrough status to investigational, oral proteasome inhibitor for AL amyloidosis

Investigational, oral proteasome inhibitor, ixazomib (MLN9708, Takeda) has FDA has granted breakthrough therapy status for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. This is the first proteasome inhibitor and first investigational therapy for AL amyloidosis to receive breakthrough therapy designation.

Express Scripts may switch hepatitis C drugs on preferred formulary

While pharmaceutical manufacturer AbbVie’s new hepatitis C drug has not yet been approved by FDA, pharmacy benefits manager Express Scripts has expressed interest in switching to the drug in its preferred drug formulary.

Prescription drug development costs skyrocket

The costs of developing new prescription drugs have soared 145% since 2003, according to a new study from the Tufts Center for the Study of Drug Development.

NIH reports first experimental Ebola vaccine produces immune response

The first experimental Ebola vaccine has been shown to be safe and prompt an immune response in results from a National Institutes of Health (NIH) phase 1 clinical trial. The vaccine produced immune system responses and was well tolerated in the whole study cohort of 20 healthy adults.

FDA approves Priftin tablets to treat latent tuberculosis infection

Following a priority review designation, FDA has approved rifapentine (Priftin, Sanofi) in combination with isoniazid (INH) for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients aged 2 years and older at high risk of progression to tuberculosis (TB) disease.

FDA drug approvals December 2014

AHA: Rivaroxaban linked to fewer hospitalization days compared to warfarin in NVAF patients

Once-daily rivaroxaban (Xartelto, Janssen) is associated with significantly fewer hospitalization days and outpatient visits compared to warfarin in patients with nonvalvular atrial fibrillation (NVAF), according to data presented at the American Heart Association (AHA) 2014 Scientific Sessions in Chicago.

WHO expands naloxone access to help manage opioid overdoses

In new guidelines, the World Health Organization (WHO) is recommending that countries significantly expand access to naloxone to help manage opioid overdoses.

PPIs may disrupt healthy gut microbiome, raise infection risk

Prolonged use of proton pump inhibitors (PPIs) may disrupt the makeup of bacteria in the digestive system, potentially raising the risk of Clostridium difficile infection (CDI), according to a study published in Microbiome.

FDA warning: Case of rare brain infection PML with MS drug Tecfidera

FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate), developed progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection, and later died. As a result, information describing this case of PML is being added to the Tecfidera drug label.

[BLOG]: Cost containment through the use of generic medications

There’s no hiding that hospital pharmacies have long been considered cost centers for healthcare systems. That positioning has been accentuated over the past 5 years, as the healthcare industry has seen a steady increase in high-cost, brand-name specialty medications that range from hundreds to thousands, sometimes tens of thousands, of dollars per dose. Nearly every hospital, however, has untapped opportunities to substantially improve efficiencies and improve costs. One important factor is improving how these hospitals use generic medications.

[BLOG]: Promising late-stage melanoma pipeline to evolve treatment algorithm

Melanoma, an aggressive disease with a rapidly rising incidence rate, presents the oncology field with some of its greatest challenges and opportunities. Long considered one of the most difficult diseases to treat with pharmacotherapy, drug development within melanoma has lagged behind that of many other cancers, culminating in decades of limited progress. Developments in molecular biology, however, have led to an increased understanding of the molecular heterogeneity of melanoma in recent years, which has resulted in new insights into the roles of oncogenes, signaling pathways, immune checkpoints, and tumor-promoting events, accelerating the rate of discovery of therapeutic targets.

Tumor treating fields with temozolomide may increase PFS in patients with newly diagnosed glioblastoma

Adding tumor treating fields (TTFields) therapy to temozolomide significantly increases progression-free survival (PFS) for newly diagnosed glioblastoma patients versus giving temozolomide alone, according to data presented at 2014 Society for Neuro-Oncology (SNO) Annual Meeting, in Miami.

ER opioid analgesic with abuse-deterrent properties approved by FDA

An extended-release (ER) opioid analgesic, hydrocodone bitartrate (Hysingla ER, Purdue Pharma) has been approved by FDA for the management of pain severe enough to require daily, 24-hour, long-term opioid treatment. Alternative treatment options must also have been found to be inadequate.

Skin cancer treatment costs soar

Treating skin cancer is having a major impact on the US healthcare system. The costs associated with skin cancer increased 5 times as fast as treatments for other cancers between 2002 and 2011, according to a Centers for Disease Control study published November 9 online in the American Journal of Preventive Medicine.

Aspirin: When should it be used for prevention of cardiovascular events?

Physicians debated the benefits versus the risks of aspirin for cardiovascular events in an editorial published in JAMA online November 17.

$125-million priority review voucher drug sale sets benchmark

Pharmaceutical manufacturers got a better idea of the value of FDA’s Priority Review Vouchers (PRVs) recently after Gilead Sciences paid $125 million in cash for Knight Therapeutics’ Neglected Tropical Disease PRV.

ACR: Lesinurad as a combo therapy with allopurinol may be effective in treating gout

Data from 2 phase 3 studies of lesinurad in combination with allopurinol in gout patients was presented at the American College of Rheumatology (ACR) 2014 annual meeting in Boston.

Drugs in Perspective: Myalept (metreleptin)

Myalept (metreleptin) is a leptin analogue with the same physiologic effects as leptin.11 Metreleptin was granted a priority review and was FDA approved on February 25, 2014, as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired lipodystrophy.

FDA reviews trial results of long-term dual antiplatelet therapy

FDA announced that it will review results from a clinical trial showing that long-term dual antiplatelet therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.

Study: Investigational drug may change course of patients’ heart failure

Investigational drug LCZ696 (Novartis), an angiotensin receptor neprilysin inhibitor (ARNI), is superior to angiotensin-converting enzyme (ACE) inhibitor alone in reducing the risks of death and of hospitalization for heart failure, according to data presented at the American Heart Association's (AHA) Scientific Sessions in Chicago.

Coalition promotes important acetaminophen dosing reminders

It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.

Dabrafenib-trametinib combo linked to improved overall survival in melanoma patients compared to vemurafenib monotherapy

Treatment with the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) significantly improved overall survival (OS) compared to vemurafenib monotherapy in previously untreated patients with BRAF V600E/K mutation-positive metastatic melanoma, without increased overall toxicity, according to a study published in the New England Journal of Medicine.

New drug approved by FDA for the treatment of relapsing MS

FDA has approved alemtuzumab (Lemtrada, Genzyme, A Sanofi Company) for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Cirrhosis patients benefit from new hepatitis C drug

The new combination hepatitis C drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) has been found to be highly effective in treating patients with cirrhosis who have not benefited from previous therapies.

FDA concerned about generic ADHD drugs

FDA has warned about 2 approved generic versions of Concerta tablets to treat attention-deficit hyperactivity disorder (ADHD).

Patients who think they are allergic to penicillin probably are not

Many people who report an allergy to penicillin actually are not allergic to penicillin, according to a study presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, in Atlanta.