News

The proper use of prescription drugs is central to a number of important regulatory and public policies issues now in the spotlight.

Two of the most commonly used treatments for neovascular age-related macular degeneration, ranibizumab, approved by FDA in 2006, and the other commonly used 'off-label', bevacizumab, resulted in similar improvements in visual acuity, according to results of a new trial.

FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.

The pipeline continues to decline from 4 to 5 years ago where smaller molecules led the way, according to a current state of the pharmaceutical pipeline presentation at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase in Minneapolis.

Chronic hepatitis C virus affects more than 170 million people worldwide and is the most common chronic blood-borne infection in the United States. Telaprevir is a member of a new class of specifically targeted antiviral therapies for HCV.

New molecular entity: Gabapentin enacarbil extended-release tablets was approved by FDA as treatment for moderate-to-severe restless legs syndrome in adults.

Multiple sclerosis is the most common disabling neurologic disease afflicting young adults in the United States. Since the majority of MS patients have normal or near-normal life expectancy, the clinical and economic burden is substantial, with disability typically worsening over time. Disease-modifying therapies have been shown to decrease and postpone long-term disability by lowering the relapse rate, extending the remission phase, and reducing the accumulation of new magnetic resonance imaging lesions and related neurologic deficits.

Within the next 5 years, approximately $100 billion will be lost on previous blockbuster brands that will lose patent protection.

Recent FDA action (through May 2011) related to Augment Bone Graft, crizotinib, DP-b99 development program, regorafenib, MCD-386CR, liver cell infusion of donated human liver cells

New biologic: Belimumab intravenous injection is a B-lymphocyte stimulator-specific inhibitor approved by FDA to treat systemic lupus erythematosus.

Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension

Recent FDA Approvals (through May 2011) related to Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev

Be nimble in product design and prepare for essential benefits and the Basic Health Plan program.

The Federal Health IT Strategic Plan is an initiative of the Office of the National Coordinator for Health Information Technology, which aims to further its goal of working with the private sector to improve quality.

Comparative effectiveness research will take a more prominent role in payer policies as the Patient-Centered Outcomes Research Institute drives research efforts.

One of the initiatives for reimbursement and care delivery within the Patient Protection and Affordable Care Act is to promote better outcomes and drive greater efficiencies within the Medicare and Medicaid programs.

Healthcare privacy regulations are getting more stringent, and the industry isn't ready.

AIHS delegates took a deep dive into the French healthcare system.

State governments are clamoring for assistance in funding fast-expanding Medicaid programs, increasingly looking to private insurers to help them save money and improve care.

Health clinics' role in the delivery system is likely to increase as previously uninsured individuals gain access to care.

Unemployment is stagnating growth in the commercial sector, but driving up enrollment in Medicaid managed care.

When it comes to all-payer claims databases, states are driving the trend.

Despite Republican attacks, the budget blueprint passed by the GOP-controlled House of Representatives likely would require an individual mandate for Medicare.

As payment reform demonstrations begin in earnest, streamlining provider incentives across all payers deserves increased attention.

A little noticed provision of the Patient Protection and Affordable Care Act offers opportunities for Medicaid managed care.

FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.

FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea.

A look at the therapeutic pipeline for glaucoma shows several medications representing new pharmacologic classes are currently being evaluated in clinical trials, said John R. Samples, MD, at ASCRS Glaucoma Day 2011, San Diego.

A newly developed assay can measure the ability of antibiotics to associate with mammalian cells and protect the cells from bacterial destruction. Of 4 antibiotics tested in this assay, the data showed a range of therapeutic effectiveness in 2 cell lines that clinicians can consider when establishing dosing regimens, according to Jeremy Wingard, MD, who reported his group's findings at the American Society of Cataract and Refractive Surgery annual meeting, San Diego.

Pirfenidone, an investigational drug (InterMune) that inhibits the synthesis of TGF-beta and TNF-alpha, was associated with positive effects on lung function, 6-minute walk test distance, and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis, according to a study published in The Lancet.