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Almost half of new molecular entities approved in 2011 considered significant therapeutic advances
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.
Budget crunch, political battles shape 2012 policy agenda
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.
Tadalafil (Cialis): A phosphodiesterase type 5 inhibitor for the treatment of benign prostatic hyperplasia
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).
Rivaroxaban (Xarelto): A once-daily oral anticoagulant newly indicated to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation
New indication: FDA approved rivaroxaban once-daily oral tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF.
Linaclotide: A guanylate cyclase type-C agonist for the treatment of constipation-predominant irritable bowel syndrome and chronic constipation
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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