The Food and Drug Administration warned Shire Plc. for enhancing benefits of Intuniv (Guanfacine) drug, indicated to treat attention deficit hyperactivity disorder in children.

The Food and Drug Administration started an investigation to review side effects of Eli Lilly blood thinner drug (Effient –Prasugrel-) and Sanofi-Aventis atrial fibrillation drug (Multaq –Drondedarone-) that could be linked to potential side effects.

A European Medicines Agency advisory panel said they have recommended use of Merck & Co. drug, Sycrest (Asenapine) indicated for bipolar disorder and schizophrenia.

The National Institute for Health and Clinical Excellence, the British office that recommends use of drugs to the National Health Service according to the benefit-cost equation, cleared AMGEN Inc. drug, Prolia (Denosumab) indicated for women at risk of fractures who can’t take existing drugs,

Roche Holding AG and Ipsen SA experimental type 2 diabetes drug, Taspoglutide, faces a possible 18 months delayed approval. The drug belongs to the GLP1 family, and recently some tested patients presented side effects such as hypersensitivity reactions were skin reactions and gastrointestinal symptoms.

U.S. biotechnology Company Human Genome Sciences Inc. announced documentation withdrawal by their European business unit for hepatitis C drug, Joulferon (Albinterferon Alfa 2b) because it expects regulators will request additional information.

The Food and Drug Administration sent a warning letter to several drug makers, specially over Gilead Sciences drug Truvada, and Biogen Idec. drug Tysabri on misleading public advertising information.

According to a public list by the Food and Drug Administration, the regulator agency continue their research of Pfizer anti-smoking drug Chantix (Varenicline) safety, after several reports of side effects.

Biogen Idec and Dublin-based partner Elan Corp. said that its sclerosis multiple drug Tysabri (natalizumab) has been linked to a new case of progressive multifocal leukoencephalopathy (PML) a deadly brain disease . During this year, four cases were detected on patients that were on Tysabri, drug that was taken off the market in 2005 and returned 18 months later.

U.S. regulators revealed that combination malaria drug Coartam marketed by Swiss drug maker Novartis AG is more effective and offer less side effects than other therapies.

The U.S. Food and Drug Administration asked more data on Novartis AG’s advanced kidney cancer treatment Afinitor (everolimus or RAD 001), delaying its approval –according to the Swiss company- by three months. No additional studies were requested.

Iclaprim, Arpida’s antibiotic to treat complicated skin diseases, achieved lower cure rates in clinical trials than Pfizer’s Zyvox, federal regulators said. Analysts said approval now looked highly unlikely.

U.S. Biotech Genentech Inc informed of a second fatal case of a rare brain infection known as progressive multifocal leukoencephalopathy (PML), on a patient taking Raptiva (efalizumab). Last October, Genentech alerted doctors and patients about a detected case of a 70 years old patient who had used the biological Raptiva for four years.

According to an analysis released by U.S. drug reviewers, an experimental antibiotic from Theravance Inc. may be related to the deaths of some patients who were treated for complicated skin infections in company studies. Theravance and Japan’s Astellas Pharma Inc. eventually will market the drug in the U.S.

U.S biotech Gilead Sciences Inc announced that plans to appeal a request by the U.S. Food and Drug Administration for an additional clinical study of the company´s experimental cystic fibrosis drug, aztreonam lysine. Gilead applied for approval of the drug to treat lung infections associated with cystic fibrosis and, at the time, the drugmaker said the FDA did not raise any significant concerns regarding the drug’s safety.

Advocacy group Public Citizen, calling for a ban of GlaxoSmithKline Plc´s diabetes treatment Avandia, said more than one dozen cases of liver failure and death have been reported. The company denies these allegations.

Japan´s Takeda Pharmaceutical Co said the Food and Drug Administration has pushed back the possible approval of key drug candidate TAK-390MR, a possible successor to its Prevacid ulcer drug, to January 31st, 2009.

U.S. Food and Drug Administration (FDA) staff have raised questions over Genzyme Corp´s data in their application for marketing a mass-produced version of Myozyme, to treat the rare genetic disorder Pompe disease. According to the regulatory agency officials, data on long-term exposure of patients does not prove the drug´s safety, either for adults or children.