News

Hepatitis C virus (HCV) infection

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

The Obama administration took action last month to shift responsibility from employers to insurance companies.

The administration's focus on rate review may have had a trickledown effect on states.

A statewide survey revealed that a majority of New York State's small business owners support health exchanges

New benefit summaries sure to ad administrative costs

Prescription coverage is one of the 10 must-have categories, but the details can vary widely among benchmark plans.

Affordable healthcare might be out of the reach of the nation's working poor.

Howard Kahn, CEO of L.A. Care Health Plan, has seen the plan grow 38% since he became chief executive in 2001.

Health Information Exchanges aim to facilitate clinical data sharing among providers, but interoperability has remained the key issue.

A new urgency for collaboration is breathing new life into old concepts.

When insurance exchanges come online, many new healthcare consumers will be members of minority populations with distinct needs.

Anxiety over jobs, for example, drives demand for mental healthcare services at a time when funding is dwindling.