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 positive patient response to the DPI. Bronchitol has received orphan drug status in both the US and Europe. Read the … [Read more...] about Positive results for Pharmaxis’s Bronchitol for CF
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Transave reports positive results for Arikace
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 Cystic Fibrosis Foundation provided almost $4 million for the development of Arikace. The inhalation … [Read more...] about Transave reports positive results for Arikace
Daiichi Sankyo launches Inavir in Japan
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 2010-2011 flu season. The product uses Hovione's TwinCaps delivery system. Read the company's press release. … [Read more...] about Daiichi Sankyo launches Inavir in Japan
ChemImage launches new testing company
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 the company's press release. … [Read more...] about ChemImage launches new testing company
MAP Pharmaceuticals appoints Thomas P. McCracken
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 of its planned commercialization, according to the company. Read the MAP Pharmaceutical press release. … [Read more...] about MAP Pharmaceuticals appoints Thomas P. McCracken
Pearl raises $69 million
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 the treatment of COPD is in Phase 2B studies, and Pearl plans to begin Phase 3 trials by the end of 2012. Vatera was founded by … [Read more...] about Pearl raises $69 million
Alexza receives complete response letter for Staccato loxapine
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. The FDA cited concerns about safety based on reductions in FEV 1 seen during Phase I studies and about stability studies … [Read more...] about Alexza receives complete response letter for Staccato loxapine
US FDA approves Aridol
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 in 19 countries. Read the company's press release … [Read more...] about US FDA approves Aridol
Positive results for VTX-1463 nasal spray
According to VentiRx Pharmaceuticals, a Phase I clinical trial of its VTX-1463 nasal spray for the treatment of allergic rhinitis demonstrated that once-weekly administration of the drug produced a significantly greater reduction in total nasal symptom scores than did a placebo. VTX-1463 is a selective toll-like receptor 8 (TLR8) agonist. Read the … [Read more...] about Positive results for VTX-1463 nasal spray
Pfizer considers divesting Capsugel
Pfizer says that it is "reviewing strategic alternatives" for its Capsugel business and that divestiture is an option. Capsugel manufactures capsules, including Vcaps hypromellose capsules for inhalation applications, and the Xcelodose powder dispensing system. 2009 revenue for Capsugel was approximately $740 million. Pfizer expects to make a decision … [Read more...] about Pfizer considers divesting Capsugel