Calls for papers
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The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on AstraZeneca’s MAA for its Fluenz intranasal influenza vaccine for use in children. Fluenz is the same live attenuated influenza virus… Read more . . .
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Strativa Pharmaceuticals has entered into an agreement with Swedish Orphan Biovitrum (Sobi) for the development and commercialization of Nascobal cyanocobalamin (Vitamin B12) nasal spray in Europe. Sobi plans to begin development for European approval in… Read more . . .
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Pharmaxis has announced that two Phase 3 trials of its Bronchitol inhaled mannitol in patients with cystic fibrosis demonstrated significant improvement in lung function with Bronchitol compared to the control group. The company also cites… Read more . . .
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Data presented at the North American Cystic Fibrosis Conference by Transave shows "improved lung function with significant reduction in bacterial density" for CF patients treated with Arikace liposomal amikacin for inhalation. An affiliate of the… Read more . . .
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Daiichi Sankyo has begun marketing its single dose Inavir laninamivir octanoate DPI for the treatment of influenza in Japan. According to the company, it plans to supply a total of 4 million units for the… Read more . . .
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Particle analysis company ChemImage has launched a new testing and consulting business called Gateway Analytical, based in Gibsonia, Pennsylvania. Gateway offers particle characterization using various spectroscopic and microscopic techniques, as well as regulatory consulting. Read… Read more . . .
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Thomas P. McCracken has joined MAP Pharmaceuticals as Vice President, Intellectual Property. MAP’s lead candidate, Levadex inhaled dihydroergotamine, is in Phase 3 trials, and McCracken will be responsible for the intellectual property program in support… Read more . . .
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A group of investors led by Vatera Healthcare Partners has added $69 million to Pearl Therapeutics’s funding, bringing the total to more than $102 million since 2007. Pearl’s lead candidate, PT003, a glycopyrrolate/formoterol MDI for… Read more . . .
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Alexza Pharmaceuticals announced that it has received a complete response letter from the US FDA in regards to its application for Staccato loxapine inhalation aerosol for the treatment of agitation in schizophrenic and bi-polar patients.… Read more . . .
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The FDA has approved Pharmaxis’s Aridol mannitol inhalation powder bronchial challenge test kit. According to Pharmaxis, the Aridol test takes less than half the time of a methacholine challenge test. Aridol has already been approved… Read more . . .
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September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK