Making good decisions requires that physicians have reliable and practical data. Comparative effectiveness reviews and objective findings on different medical interventions and strategies, as provided by the Agency for Healthcare Research and Quality in its Effective Health Care Program, can help physicians make the most informed choices among treatment options.
New molecular entities (NMEs) for calendar year 2011 number 30, considerably above the average of 23 during the past 10 years. Notably among this list are 8 drugs for cancer; 10 targeting orphan diseases; 2 each for hepatitis C and chronic obstructive pulmonary disease (COPD); and 3 anticoagulants.
Election-year politics will color a range of legislative and policy developments affecting drug development, production, and reimbursement in the coming year, as efforts to reduce government spending on healthcare prompts all parties to search for opportunities to do more with less. Looming over the political landscape is the upcoming Supreme Court decision on the constitutionality of the Obama health reform legislation.
New indication: Tadalafil once-daily 5-mg oral tablet is FDA approved for the treatment of benign prostatic hyperplasia (BPH) in patients with or without erectile dysfunction (ED).
Constipation-predominant irritable bowel syndrome (IBS-C) and chronic constipation affect millions of Americans. Use of agents currently available for treatment is not supported by well-controlled clinical studies. A new drug application for linaclotide, an orally administered guanylate cyclase type-C receptor agonist for treatment of IBS-C and chronic constipation, was submitted to the US Food and Drug Administration (FDA) with a target action date of June 2012.
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