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All News - Page 96
Pharmacist counters CDC antivirals for flu alert
January 15, 2015
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
January 15, 2015
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
January 13, 2015
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
January 13, 2015
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
January 13, 2015
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
January 13, 2015
FDA has approved carbidopa-levodopa (Duopa, AbbVie) enteral suspension for the treatment of patients with advanced Parkinson’s disease.
Pharmacologic treatment of prostate cancer
January 13, 2015
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
January 12, 2015
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
January 9, 2015
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
January 9, 2015
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
January 9, 2015
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
January 8, 2015
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
January 8, 2015
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
January 7, 2015
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
January 7, 2015
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
January 7, 2015
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
January 7, 2015
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
January 7, 2015
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.
FDA drug approvals-January 2015
January 7, 2015
FDA actions in brief, recommendations for approval, fast-track designations.
[BLOG]: Hepatitis C market competition arrives for 2015
January 6, 2015
There is plenty of activity already in the hepatitis C market as competition has arrived for 2015, including CVS Health versus Express Scripts and Gilead Sciences versus AbbVie, over FDA-approved hepatitis C treatments. This will have implications for retail prescriptions as well as continuity-of-care programs within non-Medicare accountable care organizations (ACOs) and health systems.
[BLOG]: Examining US prescription opiates utilization trends
January 3, 2015
The findings of a new research report from Express Scripts on the use of prescription opiates in the United States indicate that physicians are being more cautious about prescribing pain medications.1 The report shows both a drop in the short-term use of opioids and stabilization in the number of patients using these medications longer term.
CDC: Flu reaches “epidemic” level
January 2, 2015
After 15 children died from complications associated with the flu this season, the Centers for Disease Control and Prevention (CDC) declared the illness an “epidemic.”
Experience Brief: Desert Hospital Outpatient Pharmacy partnering with hospital to reduce readmissions among CHF patients
January 2, 2015
Desert Hospital Outpatient Pharmacy is an independent pharmacy inside Desert Regional Medical Center, a 387-bed tertiary acute care hospital located in Palm Springs, California. Desert Regional Medical Center, which has attained the Joint Commission’s Gold Seal of Approval for its congestive heart failure program, has reduced readmission rates by 17% among congestive heart failure (CHF) patients through a close partnership with Desert Hospital Outpatient Pharmacy.
Non-opioid painkiller gets FDA approval
December 31, 2014
FDA's approval of a new non-opioid painkiller injection expected to help in the fight against prescription painkiller abuse.
FDA approves new Alzheimer’s drug
December 30, 2014
FDA approved the New Drug Application (NDA) for a new treatment for moderate to severe dementia in Alzheimer’s patients.
Emergency Ebola test authorized for use
December 30, 2014
FDA issued an Emergency Use Authorization (EUA) for LightMix Ebola Zaire rRT-PCR Test for Ebola disease. The test can be used in West Africa and the United States.
Phase 3 results show significant pathological complete response for nab-paclitaxel in neoadjuvant breast cancer
December 27, 2014
The German Breast Group (GBG) said nab-paclitaxel (Abraxane) demonstrated significant benefit for patients with early high risk breast cancer when compared to conventional solvent-based paclitaxel, according to data presented at the 2014 San Antonio Breast Cancer Symposium, December 9-13 in San Antonio, Texas.
What is new in the anticoagulant antidote market?
December 26, 2014
The use of new oral anticoagulants (NOACs) continues to increase. Over the past 4 quarters, rivaroxaban (Xarelto, Bayer/Johnson & Johnson) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) were in the top 20 of fastest-growing drugs in the United States. They offer advantages compared to warfarin such as a rapid onset of action, no dietary modifications, fewer drug–drug interactions, and do not require routine coagulation monitoring.
