News

Recent FDA action (through, November 2010) related to Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502.

Recent FDA Approvals (through November 2010) related to Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron

FDA, in conjunction with Takeda Pharmaceuticals and researchers from the University of Pennsylvania and Kaiser Permanente Northern California, reported 5-year interim results of an ongoing, 10-year epidemiological study designed to evaluate whether pioglitazone (Actos) is associated with an increased risk of bladder cancer.

New molecular entity: Drospirenone/ethinyl estradiol/levomefolate calcium (Beyaz) was approved to treat symptoms of premenstrual dysphoric disorder and moderate acne in women at least 14 years of age, and to supplement folate levels in women wishing to use oral contraception.

Aspirin taken for several years and at doses ?75 mg a day was found to result in both a reduced 20-year risk of colorectal cancer incidence and mortality, according to an analysis published ahead-of-print on the Lancet website.

The worst case scenario for health plans would be if the planned expansion of healthcare coverage under the Patient Protection and Affordable Care Act evaporates, leaving insurers with added fees, onerous market regulations and fewer customers

A decade ago, health plans barely raised an eyebrow at specialty pharmaceuticals, however, this under-the-radar segment began to explode

The cost of chronic obstructive pulmonary disorder in terms of medical bills and lost productivity totals $50 billion a year, making it a condition payers can't afford to ignore.

Only about one in five respondents said their company has a program in place to analyze the impact of the Patient Protection and Affordable Care Act on their health benefits

With existing data and the tidal wave of data to come, care management can achieve significant improvements

Exchanges will be at the center of the individual and small group markets in the states and their impact is projected to be transformational

Data flows among primary care physicians, specialists and other providers, theoretically providing access to complete clinical information

One concept that Republican and Democratic legislators should be able to agree on is value-based benefit design

Seniors are satisfied with the current program (84%) because they believe it offers good value for the cost

After a 12-year upward trend, vaccination rates among children enrolled in commercial HMO insurance plans dropped almost four percentage points this year

Few plan organizations are whole-heartedly in favor of the Patient Protection and Affordable Care Act. In fact, there might be just one--the Association for Community Affiliated Plans

Behavioral health issues are garnering attention in California, and the increasing overlap of primary care and mental health has prompted a new collaboration

Lack of insurance is seen as a major obstruction to healthcare equality, but it's certainly not the only obstacle

Plans will look to mergers and acquisitions to reduce administrative costs and meet medical loss ratio requirements

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recall of Tylenol Cold Multi-Symptom liquid products; Children?s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors; Junior Strength Motrin Caplets, 24 count; and Rolaids Extra Strength Softchews, Cherry Flavor 36-count package.

Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing products containing propoxyphene from the market as well.

FDA has approved denosumab (Xgeva, Amgen), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6-month priority review by FDA. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.

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

Aetna Chairman and CEO Ronald A. Williams will retire from Aetna in April 2011. On Nov. 29, 2010, Mark T. Bertolini will be appointed chief executive officer and elected to the company?s Board of Directors.

Seven large employers, including six Fortune 500 companies and one state, have launched Catalyst for Payment Reform (CPR

UnitedHealthcare (UHC) is working with five medical oncology groups around the country to advance a new cancer-care payment model that reimburses participating medical oncologists upfront for an entire cancer treatment program.

FDA has to address multiple technical and legal issues to bring similar versions of biotech therapies to market.

FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous (IV) formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever.

Agents in late-stage development for the treatment of multiple sclerosis.

Lurasidone, a new-generation atypical antipsychotic, has been approved by FDA for the treatment of schizophrenia and is under investigation for the treatment of bipolar disorder. This article will discuss the clinical pharmacology, clinical trials, adverse events, drug interactions, dosing and administration, and formulary considerations.