FDAnews Drug Daily Bulletin

An FDA advisory panel voted 12–0 Tuesday to recommend approval of NPS Pharmaceuticals’ Gattex as a treatment for short bowel syndrome.

The Clinical Trials Transformation Initiative (CTTI) wants sponsors to put more emphasis on pediatric clinical research and begin observing pediatric patients for longer periods.

Public Citizen is urging the FDA to require boxed warnings on the labels of many top-selling hypertension drugs, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and Novartis’ aliskiren, to warn against their use in combination.

Unichem Laboratories has received ANDA tentative approval from the FDA for irbesartan tablets.

Pharma major Lupin said it has got approval from the FDA to market generic versions of Sanofi Aventis’ Avapro tablets, prescribed in the treatment of hypertension and nephropathy in Type-II diabetes.

Bristol-Myers Squibb is the only U.S. drugmaker among the top 12 to decline in trading this year, and investors and analysts say they don’t expect a comeback in 2012 because of drug pipeline setbacks.

Giving neuromuscular blocking agents as part of the anesthetic package raised the risk of respiratory complications, a large single-center study showed.

Charles River Laboratories International announced it has been selected by AstraZeneca as its preferred strategic partner for outsourced regulated safety assessment and development DMPK (drug metabolism and pharmacokinetics).

On average, new treatments perform better in clinical trials only slightly more often than existing treatments, according to a new systematic review published in The Cochrane Library.