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

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

Treatment of recurrent herpes simplex labialis with combination 5% acyclovir and 1% hydrocortisone cream is safe in adolescents. In a study of a 5-day treatment course, no safety concerns were identified, said Anders Strand, MD, PhD, at the 45th midyear meeting of the American Society of Health Systems Pharmacists, in Anaheim, Calif.

Further reductions in LDL cholesterol with more intensive statin regimens safely produce definite further reductions in vascular events, even down to very low LDL levels, lower than current targets, according to the results of 2 meta-analyses, as reported Nov. 8 online by The Lancet.

FDA is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.

CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.

FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of ADHD in adolescents aged 13 to 17 years.

FDA has approved saxagliptin and metformin XR (Kombiglyze XR, AstraZeneca and Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus DPP-4 inhibitor combination tablet offering strong glycaemic control across glycosylated hemoglobin levels, fasting plasma glucose and post-prandial glucose.