News

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.

This article will discuss the diagnosis and treatment of ADHD in adults including stimulant therapy, education and psychosocial intervention, and nonstimulant alternatives.

New combination: Aliskiren and amlodipine (Tekamlo) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals, in hypertensive patients not adequately controlled with monotherapy, or as a substitute for its individual components.

The protease inhibitors boceprevir and telaprevir, in phase 3 development, are poised to become a new therapeutic category of medications to be added to the current standard of care to increase sustained virologic response rates and prevent liver disease in patients with hepatitis C.

Recent FDA Approvals (through October 2010) related to Latuda, Ofirmev, Cymbalta, Botox, Pradaxa, Afinitor, Teflaro, Herceptin, Kapvay

New combination: Olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) have been recently approved by FDA as an initial therapy to treat hypertension in patients likely to need multiple drugs to achieve their blood pressure goals.

Generic drugs approved by FDA (through October 2010): Extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex

Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.

Congress has enacted legislation mandating notice to individuals whose personal information has been compromised

When it comes to insurance, the latest figures from the U.S. Census Bureau show 2009 was a year of superlatives, and none of them good.

New worries should not distract executives from addressing rising costs and threats of consolidations

The federal government is out to change the nature of healthcare from reactive to proactive

HHS is providing some breathing room before employers and insurers have to meet new requirements

The most powerful person in the nation's healthcare system made a heartfelt call for industry assistance in reforming healthcare.

Employers are beginning to focus on price in the broader context of value according to industry analysts

New regulations challenge Medicare Advantage products, but HealthSpring is relying on the future outlook for larger plans in the MA market

The adoption of healthcare reform has created an environment that encourages insurers, health plans, hospitals and clinicians to seek common ground

California is making a statement as the first state to create an oversight board for insurance exchanges, in compliance with the requirements established by the Patient Protection and Affordable Care Act

Many of the estimated 5.1 million Americans with Alzheimer's disease also have other serious medical conditions

As healthcare stakeholders try to steer consumers to the most effective care delivery, they first need to overcome longstanding hurdles, including reliable quality measures

Consolidation is going to heat up in healthcare for two reasons

FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight (and have at least 1 weight-related co-morbid condition.

OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.

Childhood obesity has tripled in the past 30 years, leading to many chronic lifelong conditions. Obese children, for example, are more likely to have risk factors for cardiovascular disease, are at greater risk for bone and joint problems, and are more likely to become overweight as adults.

The newly created Center for Medicare and Medicaid Innovation (CMI), which was created by the Patient Protection and Affordable Care Act (PPACA), has an acting director. Richard Gilfillan, MD, who has directed the Centers for Medicare and Medicaid Services' (CMS') performance-based policy staff since August, has been named acting director of CMI.