News

Recent FDA action (through, December 2010) related to Ezogabine, Ticagrelor, Naltrexone SR/bupropion, Clostridium difficile vaccine, Elacytarabine, Glycerol phenylbutyrate, Perifosine, Cladribine Tablets, Florbetapir, ALS-AVP-21D9, Cyclosporine, PRX-8066, QLT091001.

New indication: Denosumab (Xgeva) has been approved for prevention of skeletal-related events from bone metastases from solid tumors.

Patients with rheumatoid arthritis who are seen by a rheumatologist within 12 weeks of symptom onset were likely to experience less joint destruction and have a higher chance of achieving disease modifying anti-rheumatic drug-free remission, according to a new study published December 2010 in Arthritis & Rheumatism.

Parkinson's disease, which decreases the amount of dopamine in the brain, affects about 1 million Americans. Available medical therapy cannot modify the progression of the disease; medications have only been shown to alleviate its symptoms.

Generic drugs approved by FDA (through December 2010): Levocetirizine tablets

New combination: Saxagliptin and metformin extended release (Kombiglyze XR) was approved to improve glycemic control in adults with type 2 diabetes mellitus.

Antihypertensive therapy with an angiotensin receptor blocker is not associated with reductions in cardiovascular or all-cause mortality compared to non-ARB-based regimens in patients with type 2 diabetes, according to researchers at the Massachusetts College of Pharmacy and Health Sciences.

Recent FDA Approvals (through December 2010) related to Amturnide, Prezista, Safyral, Gardasil, Atelvia

As compared to fluorouracil, doxorubicin, and cyclophosphamide, an adjuvant taxane-based regimen containing docetaxel, doxorubicin, and cyclophosphamide was shown to increase the rate of disease-free survival by 32% among women with high-risk, node-negative breast cancer.

FDA is requiring a new warning be added to the prescribing information for saquinavir (Invirase) detailing the drug's potential to prolong both QT and PR intervals on an electrocardiogram, and thus potentially cause the dangerous abnormal heart rhythms called torsades de pointes and complete heart block.

Technosphere insulin is an inhaled form of regular human insulin with a rapid onset of action (~15 min) that is being considered for approval for the treatment of type 1 and type 2 diabetes mellitus. Technosphere insulin has shown efficacy in decreasing the level of glycosylated hemoglobin in a dose-dependent manner.

Top-selling pediatric OTC analgesic, cough and cold, allergy, and gastrointestinal liquid medications in the United States are plagued with highly variable and inconsistent dosing directions and measuring devices, according to a study published ahead-of-print on the Journal of the American Medical Association's website.

Researchers from the Cincinnati Children's Hospital Medical Center have demonstrated that the tumor necrosis factor-alpha inhibitor etanercept is associated with significant increases in height, weight, and body mass index in children with juvenile idiopathic arthritis, according to a study recently published in Arthritis & Rheumatism.

Oncology treatment and benefits are changing. Buy-and-bill, the traditional methodology that had physicians buy chemotherapeutic products, treat in the office, and bill the payer, is going the way of surgery by barbers. But no one is quite sure what will replace the one-time standard of payment.

Based on "a review of emerging safety information from clinical trials and postmarketing reports," Pfizer announced it would be voluntarily withdrawing sitaxsentan (Thelin), the manufacturer's pulmonary artery hypertension (PAH) treatment from the market worldwide.

The political tensions wrought by last November's mid-term elections will play out in a number of situations affecting health plans and pharmaceutical companies this year.

Patients who switch statins have lower persistence to therapy compared to those who don't switch, found Gary J. Tereso, PharmD, director of pharmacy services at Health New England, Springfield, Mass.

A newly approved drug, denosumab (Xgeva, Amgen), delays skeletal-related side effects for 5 months longer compared to zoledronic acid (Zometa and Reclast, Novartis) in patients with breast cancer and bone metastases, according to phase 3 trial results presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.

As legislation requiring standardized member identification cards is considered in New Jersey, proponents view the cards as a step toward reducing administrative costs

The feds are moving aggressively to breathe life into many new programs authorized by the Patient Protection and Affordable Care Act, now nearly a year old

Bipolar disorder leads to unusual shifts in mood, energy and activity levels. The disorder can be difficult to diagnose, because symptoms may appear as separate issues that aren't recognized comprehensively.

A new book, "Deadly Spin," goes after corporate PR, contending that it is ruining healthcare and deceiving Americans.

The certification of rules regarding medical-loss ratios brings some clarity to an issue that has tried the patience of health plans, but now the hard work begins, according to analysts.

Employers are staying in the insurance game, much as they may grouse about the cost and hassles associated with providing health coverage

There's a large gap in private insurer inpatient payment rates among regions, with Miami-South Florida averaging 147% of Medicare rates, while San Francisco came in at 210%

National attention has been focused on childhood immunization in light of a California pertussis epidemic, but adults who could unwittingly transmit infectious diseases remain largely unvaccinated.

Analysts and experts have written a lot about ICD-10 and the significant changes it will bring to health plan operations.

One of the costliest pitfalls of administration is litigation stemming from denials.

Health professionals at the University of Kansas Hospital are looking within themselves to improve their own personal health

Because of the disparate nature of health IT systems, the data is so fragmented it's actually hampering clinical decisions