An experimental Novartis drug can clear malaria infection in mice with a single dose and scientists say it shows promise as a possible future treatment for one of the world’s major killer diseases.
In a study published in the journal Science on Thursday, an international team of scientists said the drug, called NITD609, is effective against [...]

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Asenapine therapy was cleared in the U.S. in 2009 to treat schizophrenia and bipolar disorder mania.
Merck & Co’s non-U.S. business, MSD, reported approval throughout the EU for Sycrest®, a sublingual asenapine drug for treating moderate to severe manic episodes in adult patients with bipolar I disorder. Sycrest was first approved in the U.S. in 2009, [...]

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A study funded by Abbott Laboratories offered more detailed evidence that its weight-loss drug Meridia increases heart risks, prompting renewed calls by consumer advocates and others to pull the drug from the market.
Final data from the so-called SCOUT study, published on Wednesday, showed Meridia increases the risk of heart attacks and strokes in patients who [...]

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The FDA has asked AstraZeneca’s MedImmune for more data on motavizumab, a monoclonal antibody being considered to help prevent serious respiratory syncytial virus. The disease is a major cause of lower respiratory tract infection and hospital visits in infants and children. In the complete response letter, the agency said it would need data from an additional [...]

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Japanese drugmaker Eisai’s blood clot candidate E5555 may be able to reduce heart attacks, strokes and cardiovascular deaths without increased serious bleeding risks, researchers say.
Scientists evaluated E5555, a new protease-activated receptor 1 inhibitor, in two Phase II trials in Japanese patients to assess the drug’s safety and tolerability. The researchers also wanted to determine its effects [...]

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Tekamlo is a single pill that contains both a direct renin inhibitor and a calcium channel blocker.
FDA approved Novartis’ Tekamlo™ tablets for the treatment of high blood pressure. Tekamlo is a single pill combining the direct renin inhibitor Tekturna® (aliskiren) with the calcium channel blocker amlodipine. It is approved as initial therapy for patients who [...]

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New BLA is expected to be submitted in mid-2012.
FDA has sent Genentech a refuse to file (RTF) letter with regard to the BLA for accelerated approval of trastuzumab-DM1 (T-DM1) in metastatic breast cancer. The agency stated that the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for [...]

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On September 20, an FDA expert panel will review Boehringer Ingelheim’s Pradaxa (dabigatran), an experimental blood thinner that the company says is safer, more effective and simpler to use than the generic warfarin. The drug is indicated to prevent stroke in those with irregular heartbeats.
It’s good news for Boehringer, as some analysts speculated an expert [...]

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An experimental personalized cancer therapy from Roche and Plexxikon registered striking results in a recent clinical study, shrinking the tumors in a majority of metastatic melanoma patients who share a common genetic mutation. And a group of experts in the field are lauding the results, saying that the success of this study could help pave [...]

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Perampanel decreased median seizure frequency and improved responder rates.
Eisai reported positive results of a Phase III study with perampanel (E2007) for the treatment of partial seizures in patients with epilepsy. The compound is a highly selective noncompetitive AMPA-type glutamate receptor antagonist.
The double-blind, placebo-controlled, parallel-group study (study 306) showed that perampanel was effective in reducing median [...]

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