A group calling itself Safe and Healthy Use of Nasal sprays (SHUN) is trying to get out the message that "Addiction to over-the-counter medicated nasal spray is a serious problem in the United States" and says that its mission is "to ensure that all Americans know about the consequences of this overuse and the treatment alternatives. The group, … [Read more...] about Group advises consumers to “SHUN” nasal sprays
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AstraZeneca gets positive opinion for Fluenz
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 (LAIV) product marketed in the US by MedImmune under the name FluMist. Read the company's press release. … [Read more...] about AstraZeneca gets positive opinion for Fluenz
European development deal for Strativa’s Nascobal
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 early 2011 and will help to finance an upgrade of Strativa's facilities necessary to meet EU regulations. QOL … [Read more...] about European development deal for Strativa’s Nascobal
Positive results for Pharmaxis’s Bronchitol for CF
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
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