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Andrew von Eschenbach, MD, has faced a number of tough issues since he was sworn in as FDA's commissioner in December 2006, not the least of which is drug safety. Fewer new drugs have been coming to market, and pressure continues to mount for FDA to do more with limited resources. Legislation to reauthorize user fees for pharmaceutical and medical device manufacturers has to be approved by Congress by September 30, 2007, or FDA will have to lay off hundreds of staff members. The need for speedy legislative action has focused public attention on agency operations and policies, a trend likely to continue as the nation's healthcare system and prescription drug costs become a central issue in next year's presidential elections.

The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135

In the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) study, initial treatment of hypertension with a fixed-dose, dual-drug combination demonstrated "unprecedented" levels of control at 18 months.

Nebivolol is associated with long-term control of blood pressure and is as effective in obese patients as in nonobese patients with hypertension, according to the results of a 9-month extension study and a post-hoc analysis that were presented at the American Society of Hypertension 22nd Annual Scientific Meeting and Exposition.

Chronic hepatitis B is a common disease worldwide with significant morbidity and mortality. Early diagnosis is essential but difficult, as most patients with chronic hepatitis B do not have specific symptoms until the symptoms of advanced disease occur. The main goal of therapy is to prevent cirrhosis and hepatocellular carcinoma by suppressing hepatitis B virus (HBV) DNA levels. The decision to treat and the choice of therapy require careful consideration of both patient and drug characteristics, as stated in both an expert panel consensus recommendation and the American Association for the Study of Liver Diseases (AASLD) treatment guidelines. Lamivudine, once the mainstay of oral antiviral treatment, has been supplanted by newer agents such as adefovir, entecavir, and telbivudine, which produce less drug resistance overall; these oral agents often require long-term treatment. Pegylated interferon alfa-2a, which has a predefined treatment course but is often poorly tolerated, is now the main option in..

The latest FDA action (through July 2007) related to tramadol (Labopharm), SPD465 (Shire), continuous erythropoiesis receptor activator (Roche), fosaprepitant (Merck), ACAM2000 smallpox vaccine (Acambis), repository corticotropin injection (Questcor), rimonabant (Sanofi-Aventis), tamibarotene (Innovive), mycophenolate (Aspreva), romidepsin (Gloucester), aripiprazole (Otsuka/Bristol-Myers Squibb), AMT 011 (Amsterdam Molecular Therapeutics), aminolevulinic acid (Dusa), cyclosporine A (Novagali), and ARD-07 (Ardana)