Formulary Watch |

HSCA to FDA: Address backlog of generic drug applications

The Healthcare Supply Chain Association (HSCA) recently sent a letter to FDA urging timely implementation of the remaining provisions of the Generic Drug User Fee Amendment (GDUFA).

7 proven elements of a successful antibiotic stewardship program

Earlier this year, the Obama Administration announced a 5-year plan to combat antibiotic resistance. The Forum on Antibiotic Stewardship was created to meet this "growing public health threat" and to reduce the misuse of antibiotics.

Antiepileptic drug can now be used in pediatric patients

FDA has expanded the indication for topiramate (Qudexy XR, Upsher-Smith Laboratories) extended-release capsules within the pediatric population.

Combo therapy yields intriguing results in melanoma progression

Results of a new study on combination drugs used to treat melanoma were presented at the 2015 American Society of Clinical Oncology meeting in Chicago. Researchers showed that a combination of ipilimumab and nivolumab stopped the advancement of melanoma for nearly a year in 58% of cases.

Continued advances in cancer outcomes unveiled at ASCO

Leading cancer drugs reduced the risk of death by half for people with lung cancer and assisted patients with HER2-positive breast cancer live longer without the disease recurring. The findings were just two of the numerous important study results presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago, Ill., this week.

FDA grants priority review to expand use of Brilinta

The FDA has granted Priority Review for ticagrelor (Brilinta, AstraZeneca) for patients with a history of heart attack.

[BLOG]: Use and abuse of opioids: FDA responds

In this blog post, David Calabrese RPh, MHP and Andrea Marks, MS discuss Catamaran's research on opioid abuse. Catamaran is concerned about opioid misuse and is moving forward with plans to combat opioid abuse.

Two TKIs go head-to-head in squamous cell carcinoma of the lung study

In patients with advanced squamous cell carcinoma (SCC), afatinib significantly improved overall survival (OS) compared to erlotinib, according to data presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

PCORI awards prison system $2M to study naltrexone benefit in opioid abuse

The Patient-Centered Outcomes Research Institute (PCORI) recently awarded more than $2 million to the University of Pennsylvania for research on opioid addiction treatment and relapsing in the Philadelphia Prison System. The study assesses the effectiveness of naltrexone to prevent relapse.

Dosage breakthrough for schizophrenia drug, plus 5 more FDA approvals

FDA approvals for the first week of June 2015.

Drug approved for rare, lung disease that strikes younger women

Lymphangioleiomyomatosis (LAM) is a rare, progressive lung disease that primarily affects women of childbearing age. The FDA has approved sirolimus (Rapamune, Pfizer) as the first drug to treat LAM. Rapamune was originally approved to prevent organ rejection.

Once-daily maintenance combo drug approved for COPD

FDA approved once-daily tiotropium bromide and olodaterol (Stiolto Respimat, Boehringer Ingelheim) Inhalation Spray as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

IL-6 inhibitor shows positive clinical benefit in RA patients

Sarilumab may be an effective option for patients with moderately-to-severely active rheumatoid arthritis (RA) according to topline results from a new study.

COPD fixed-dose combo enhances lung function

Because lung function can be substantially reduced by the time most chronic obstructive pulmonary disease (COPD) patients first see a physician, maintenance treatment should be considered at the time of diagnosis, according to new data analyses presented at the American Thoracic Society (ATS) 2015 International Conference.

Investigational dual bronchodilator improves lung function over single bronchodilators in COPD

In patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), investigational indacaterol/glycopyrronium (QVA149) bromide significantly improved lung function compared to the single bronchodilators, according to data presented at the American Thoracic Society (ATS) International Conference in Denver, May 15 to 20.

Grassroots FDA partnership aims to reduce heart disease deaths

FDA has joined nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society in a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.

The 5 most over-prescribed antibiotics

Because of overuse and misuse, some antibiotics are losing effectiveness against highly resistant bacteria.

First concentrated mealtime insulin analog approved

The FDA approved Eli Lilly’s Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), the company announced on May 27.

Breast cancer drug research roundup from ASCO

Among the many poster sessions being presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL, are several on the latest trials that are planned to evaluate potential treatment options for breast cancer. These trials include 1 phase 2 study and 3 phase 3 studies.

FDA approves 2 new IBS-D treatments

The FDA approved two new treatments to treat irritable bowel syndrome with diarrhea (IBS-D), Viberzi (eluxadoline) and Xifaxan (rifaximin), this week.

Edoxaban: An oral inhibitor of factor Xa

FDA drug approvals-May 2015

FDA actions in brief, complete response, breakthrough therapy designation, fast-track designations, orphan drug designations

High healthcare costs driven by spike in Rx costs

A significant spike in prescription drug costs helped drive healthcare costs for families covered under an average employer's health insurance plan up an estimated 6.3% in 2015, according to the Milliman Medical Index (MMI) report.

CVS’s Omnicare acquisition signals specialty drug expansion

CVS Health’s acquisition of Omnicare for $12.7 billion is expected to significantly expand the drug chain’s business in specialty pharmacy, generics and long-term care.

Battle of the cholesterol drugs expected

This summer, Amgen and Regeneron Pharmaceuticals/ Sanofi will battle it out in the competitive cholesterol market. Repatha and Praluent, respectively, are expected to be approved by the FDA this summer.

Harvoni could save US, Europe $3.2 billion

The higher cure rate of treating hepatitis C patients with a combination of ledipasvir and sofosbuvir (Harvoni) led to substantially better work productivity, according to a new study. In fact, improved work productivity and lack of absenteeism could save the United States and 5 European countries more than $3.2 billion a year.

J&J-Achillion partner to develop hep C drugs

Johnson & Johnson is expanding its reach in the lucrative hepatitis C drug market after announcing it will collaborate with Achillion Pharmaceuticals to develop its HCV drugs.

Biosimilars need better labeling: Physicians

In FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing decisions," including clear statements of a product's approval as a biosimilar to a reference product and whether or not it has been determined to be interchangeable.

Covered California imposes price caps for specialty drugs

Health exchange Covered California said it is the first in the United States to adopt benefit design changes to improve access to high-cost specialty drugs.

Long-acting schizophrenia drug may help with medication adherence

FDA has approved the first and only 4-times-per-year schizophrenia drug.