New indication: Pneumococcal 13-valent conjugate vaccine (Prevnar 13) was granted accelerated FDA marketing approval for the prevention of pneumonia and invasive disease (infection of blood or spinal fluid) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults age 50 years and older.
Warfarin is similar to aspirin in preventing deaths and strokes in patients with heart failure and normal heart rhythm, according to the largest and longest head-to-head comparison study of the 2 anticlotting drugs.
A new analysis of the phase 3 IMPACT study has found that sipuleucil-T (Provenge, Dendreon) increases survival times by an estimated median of 7.8 months in patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.
Recent FDA Approvals (through February 2012) related to (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)
Minorities are less likely to receive a depression diagnosis and be treated for it than non-Hispanic Whites, according to a new study published on-line and ahead-of-print on December 15, 2011, in the American Journal of Public Health.
The increase in utilization of medications for psychological and behavioral disorders can be attributed to greater awareness among patients that mental health disorders are treatable and that available drug therapies are safe and effective, according to David Muzina, MD, a national practice leader of the Medco Neuroscience Therapeutic Resource Center.
After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.
Cost concerns continue to dominate benefit design, resulting in greater cost-sharing from employees, according to survey findings from managed care decision-makers, self-insured employers, and employee benefits consultants.
New molecular entity: FDA approved ruxolitinib, a twice-daily tablet, indicated for the treatment of myelofibrosis.
Second-generation antipsychotics are the mainstay of treatment in schizophrenia.
Every 5 years, Congress is called on to reauthorize a series of user fees that support FDA oversight of drugs and medical products. The Prescription Drug User Fee Act (PDUFA) and similar measures authorizing fees to fund a number of FDA regulatory programs have become increasingly vital for maintaining the agency's ability to maintain an efficient approval process for new therapies.
The 2012 vaccination schedules for children, adolescents, and adults have been released, with changes to the recommendations for meningococcal and human papillomavirus (HPV) vaccinations in children and in hepatitis B vaccinations in adults.
Uncontrolled diabetes may result in hearing loss in women, much like it affects vision or kidney function, according to the results of a new study.
FDA has notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis, Merck) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these drugs when they are used together.
The use of proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), according to a recent FDA Drug Safety Communication.
Vorapaxar added to standard of care reduced the risk of cardiovascular events and stroke compared to standard of care alone, according to Merck, who announced top-line results of its TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) study earlier this month. However, results also demonstrated that the drug was associated with a significant increase in bleeding, including intracranial hemorrhage (ICH).
The antiplatelet arm of The Secondary Prevention of Small Subcortical Stroke (SPS3) study was halted in July 2011 due to reasons of safety and futility, according to principal investigator Oscar R. Benavente, MD, FRCP (C), professor of neurology at Canada's University of British Columbia in Vancouver, British Columbia.
Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate
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A new weight-loss medication got an overwhelming endorsement on Wednesday from FDA?s Endocrinologic and Metabolic Drugs Advisory Committee. The committee voted 20-2 in favor of approving phentermine/topiramate (Qnexa, Vivus).
A recent study challenges the conventional assumption about how Clostridium difficile infection spreads in hospitals, finding that almost three-quarters of the new cases aren?t transmitted by patients in the same ward.
No significant difference was found in treating patients experiencing clinically diagnosed uncomplicated acute rhinosinusitis with antibiotic amoxicillin compared with patients who received placebo, according to a study in the February 15 issue of JAMA.
There are no beneficial effects of supplementation with relatively low doses of B vitamins and/or omega-3 fatty acids on cancer outcomes in individuals with prior cardiovascular disease, according to a study published online February 13 in the Archives of Internal Medicine.
Zinc used in conjunction with antibiotics significantly reduced mortality in children ages 6 months to 59 months with severe pneumonia when compared with antibiotics alone, according to the findings of a recent study done in Uganda.
The Advisory Committee on Immunization Practices (ACIP) wants all US adults to get vaccinated against whooping cough, according to the Associated Press. The panel voted to expand its recommendation to include all those aged 65 years and older who haven?t gotten a whooping cough shot as an adult.
FDA announced a series of steps to increase the supply of critically needed cancer drugs, including temporarily importing an unapproved drug from India. The moves are building on President Barack Obama's executive order to help prevent future drug shortages, FDA said
