Soon after FDA expressed concerns over the higher dosages and safety profile, including daytime drowsiness, of the proposed sleep agent known as suvorexant (Merck), the Agency’s Peripheral and Central Nervous System Drugs Advisory Committee voted 13-3, with 1 abstention, in favor of the safety of 2 proposed starting doses of suvorexant - 15 mg in patients over the age of 65 and 20 mg in patients under the age of 65.
Sandoz is conducting a voluntary nationwide recall at the U.S. hospital/user level of 2 lots of its injectable methotrexate sodium, USP, 25 mg/mL, 40 mL vials, as a result of the discovery of particulate matter during routine quality examination of vials included among the manufacturer’s retention samples.
Due to a recurring error that sometimes prompts FreeStyle InsuLinx Blood Glucose Meters to display false test readings, Abbott Diabetes Care has voluntarily recalled the product.
An examination of people’s behaviors as they relate to drug use in the 20th century has shown that people will expend a large amount of energy to acquire any agent that has the ability to alter their minds, bodies, or behaviors in order to achieve a euphoric effect.
The proposal of the investigational sleep agent called suvorexant (Merck), is believed to target sleep disturbances and insomnia through a different mechanism compared to the agents that are currently on the market, but FDA has concerns over the higher dosages of the drug and its safety profile.
Actavis Inc. announced May 20 its plans to acquire Warner Chilcott in a stock transaction deal, which is worth approximately $8.5 billion. The merger is expected to create a global specialty pharmaceutical company serving the women’s health, gastroenterology, urology, and dermatology therapeutic sectors, according to a joint company release.
Senators from the Health, Education, Labor and Pensions (HELP) Committee have introduced a revised version of its draft compounding bill to help improve the safety of compounded human and animal drugs, following feedback earlier this month from stakeholders, including the American Society of Health-System Pharmacists (ASHP).
Pharmacists working in a collaborative relationship with physicians in different practice settings were able to help more patients with type 2 diabetes achieve glycemic control without adding to the medication burden, according to a report published May 8 in The Annals of Pharmacotherapy.
Hepatitis C testing and reporting must be improved as the mortality rate of HCV is high among those who are relatively young, according to a new study published in the May 7, 2013, Morbidity and Mortality Weekly Early Release on its website.
Patients with multiple cardiovascular (CV) risk factors are not able to reduce their mortality risk from CV causes with daily n-3 polyunsaturated fatty acid intake, according to a long-term Italian study published May 9 in the New England Journal of Medicine.
Because of the need for early detection, improved antiviral agents, and changes in the availability of commercial Hepatitis C virus (HCV) tests, the Centers for Disease Control and Prevention (CDC) has issued a new guidance for clinicians and laboratorians.
PPACA will address many of the out-of-pocket costs for various age groups.
Plans must expand their distribution channels and engage new customers
FDA has denied Endo Health Solutions' petition to block generic forms of its opioid agonist Opana ER, which contains oxymorphone. FDA’s decision comes just weeks after it nixed generic OxyContin and approved abuse-deterrent labeling for reformulated OxyContin (Purdue Pharma).
Individuals who regularly take statins to reduce high cholesterol will see lower hospitalization rates according to a study presented at the Academy of Managed Care Pharmacy’s 25th Annual Meeting & Expo in San Diego, in April.
Plans should consider adapting similar strategies from online product exchanges to prepare for 2014.
Migraine prevention drugs used during pregnancy can cause decreased IQ scores in children born to mothers who take these medications, according to an FDA alert.
Zoster vaccination was associated with a reduction in post-herpetic neuralgia among those who are aged 65 and older, according to a study, published in PLoS Medicine. However, they also found that the use of the shingles vaccine was also very low among certain population groups
Interim data from a phase 2, multicenter, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172 (Merck), for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, was presented at the 2013 International Liver Congress, 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam.
Data from a meta-analysis of 5 boceprevir (Victrelis, Merck) phase 3 clinical studies was presented at the 2013 International Liver Congress, 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam.
FDA has approved ezetimibe and atorvastatin (Liptruzet, Merck) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet, according to the manufacturer.
A group of doctors and researchers is protesting the high cost of certain cancer drugs and is urging pharmaceutical companies to make changes.
Trust is deteriorating, and that can work against payers attempting to enter alternative contracts
KPMG's 2013 first quarter M&A deal report
Two healthcare giants in Michigan enter three-year deal to improve cost trend and reinforce infrastructure
Greater dietary fiber intake is significantly associated with lower risk of first stroke, according to a recent study published in Stroke.
For critically ill adults with multiorgan failure, early supplementation with glutamine or antioxidants does not improve clinical outcomes, and glutamine may increase the mortality rate of this patient population, according to a study published in the April 18 issue of the New England Journal of Medicine.
Eighteen years of follow-up of the Prostate Cancer Prevention Trial (PCPT) suggests that 7 years of treatment with the 5-alpha-reductase inhibitor finasteride (Proscar) for prostate cancer prevention does not appear to affect mortality but does reduce the risk of a prostate cancer diagnosis.
Older men with metastatic castration-resistant prostate cancer (mCRPC) derive a similar if not superior survival benefit from treatment with enzalutamide as do younger men, according to a post-hoc analysis of the phase III AFFIRM trial.
