News

Recent FDA approvals (through December 2009) related to Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, and Byetta.

Generic drugs approved by FDA (through December 2009): Lansoprazole 15 mg and 30 mg tablets and Perindopril erbumine tablets, 2 mg, 4 mg, and 8 mg

New indication: Telmisartan tablets (Micardis) was approved on October 19, 2009, for cardiovascular risk reduction for patients unable to take an ACE inhibitor.

Generics makers have aggressively challenged drug patents before scheduled expiration, while brand-name manufacturers have delayed generic entry through 30-month stays, citizen petitions, and deals to "authorize" generic products that are less threatening to the brand.

Evidence-based recommendations utilize an integrated approach that combines nonpharmacologic approaches (specifically patient education, exercise, and cognitive behavioral therapy) and pharmacologic approaches in the management of fibromyalgia.

Two leading industry groups put their heads together for seemless care

Secondary use of electronic data from claims and clinical sources will drive savings

Tweak them all you want, policies still lack enough action to truly bend the cost curve

More than 4 million annual provider visits, including visits to the ER, can be attributed to adverse drug events

Dig into the minds of members and you'll find that they don't always make logical choices. Behavioral economics can shed light on their thought process

Only 20% of PDPs will offer gap coverage, and even then, most are limited to generics. House and Senate bills aim to help out.

Let no assumption go unchallenged in this new era of healthcare, including the one that says rhinovirus is 'just' the common cold

Commonwealth Fund State Performance Ranking (2009): 48

Healthcare is funded by taxes and subsidies, but privately insured people are encouraged to buy upgrades

New plans are entering the market in spite of the uncertainty

Charles Kennedy, MD, plays a vital role in WellPoint's innovative health record that contains clinical benchmarks

For the 15% to 20% of patients who don't respond to initial treatment, tumor necrosis factor inhibitors can reduce inflammation

Financial incentives and penalties are no longer permitted when genetic information is requested on health risk assessments

An economic impact analysis found that Blue Cross Blue Shield of Massachusetts' (BCBSMA) contributed nearly $1.6 billion to the Commonwealth?s economy.

CVS Caremark research finds $0 copay for generic medications can increase dispensing.

Medical Group Management Association (MGMA) study highlights member satisfaction with major health plans.

Medica releases iPhone app based on MainStreetMedica.com, which helps consumers compare costs of medical procedures.

Discovery of flaw in system leads Rocky Mountain Health Plans to change policy regarding coverage of heavy babies.

Agents in late-stage development for the treatment of gastrointestinal disorders

New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

This article reviews the 10 newly improved or investigational agents evaluated in this year's "Focus on" column and includes an update on the regulatory status of each drug.

Patients with inflammatory bowel disease receiving thiopurines are at increased risk of developing lymphoproliferative disorder, according to a French prospective observational cohort study, which was published online in The Lancet.

An investigation into a multistate outbreak of Serratia marcescens bloodstream infections (BSIs) published in the Archives of Internal Medicine found an association between the BSIs and contamination of prefilled syringes.

New combination: Valturna was approved on September 16, 2009, for the treatment of hypertension in patients not adequately controlled on either aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

FDA is struggling to implement a host of new drug safety policies and programs and still meet review time frames set by the Prescription Drug User Fee program (PDUFA).