Two days after announcing that it had licensed VR315 in the US to an undisclosed pharmaceutical company, Vectura announced that Sandoz has licensed the product in the rest of the world. Sandoz already has an existing agreement with Vectura to market the DPI product in Europe. VR315, delivered by the Gyrohaler dry powder inhaler, is a fixed dose combination product for … [Read more...] about Vectura announces additional licensing agreement for VR315
News
Nycomed and Orion to co-market Easyhaler DPI products for asthma and COPD
Finnish pharmaceutical company Orion Corporation will co-market combination products delivered by its Easyhaler dry powder inhaler with Nycomed. The agreement covers major European countries, the Middle East, and North Africa. Orion will manufacture the products and will maintain exclusive rights in the UK, Eastern Europe, and the Nordic countries. Each company will … [Read more...] about Nycomed and Orion to co-market Easyhaler DPI products for asthma and COPD
NIH-developed antigen licensed for intranasal RSV vaccine
University of Michigan spin-off NanoBio has licensed a novel respiratory syncytial virus (RSV) from the US National Institutes of Health (NIH). NIH developed the antigen using proprietary technology. No approved vaccine for RSV currently exists; several previous RSV vaccine candidates have failed after they led to advanced respiratory disease. “We are very pleased … [Read more...] about NIH-developed antigen licensed for intranasal RSV vaccine
Undisclosed pharmaceutical company licenses Vectura generic DPI in US
Vectura is not saying which international pharmaceutical company's US division has entered into a "collaboration, development, and license agreement" for the VR315 dry powder inhaler. VR315 is a fixed dose combination therapy for asthma and COPD, delivered using the Gyrohaler DPI. The new partner will develop, manufacture, and commercialize the product in the US in … [Read more...] about Undisclosed pharmaceutical company licenses Vectura generic DPI in US
MHRA issues warning on Ubertan nasal spray
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is warning consumers against using a "fake tan nasal spray" marketed as Ubertan. According to the agency, the product comes in two versions, one of which contains "melanotan II, an unlicensed medicine with no evidence of safety, quality or that it works, and with unknown side effects" and another that … [Read more...] about MHRA issues warning on Ubertan nasal spray
Clinical hold placed on Arikace trials
The US FDA has notified Insmed that it has placed a clinical hold on Insmed's trials of Arikace liposomal amikacin for inhalation. The ongoing Phase 3 program for the use of Arikace in cystic fibrosis (CF) patients with P. aeruginosa lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease will be suspended pending review of additional data … [Read more...] about Clinical hold placed on Arikace trials
FDA accepts NDA submission for the Levadex dry powder inhaler
A goal date of March 26, 2012 has been set for the NDA submitted to the FDA for MAP Pharmaceuticals' Levadex inhaled dihydroergotamine (DHE) for the treatment of migraine in adults. The acceptance triggered a $20 million milestone payment to MAP from Allergan, which has partnered with MAP on development of the product in the US. Ownership of the NDA will be retained … [Read more...] about FDA accepts NDA submission for the Levadex dry powder inhaler
Sanofi licenses Flutiform in Mexico and in Central and South America
SkyePharma has announced that it has entered into a development, license, and marketing agreement for its Flutiform fluticasone and formoterol combination MDI with Sanofi in Mexico, Central America and South America. Sanofi will submit marketing authorization applications for Flutiform in the region, including in Brazil, Mexico, Venezuela, Argentina, and Colombia. The … [Read more...] about Sanofi licenses Flutiform in Mexico and in Central and South America
Asthma drug costs more than doubled for US children over a decade
According to the US Health and Human Service Department's Agency for Healthcare Research and Quality (AHRQ), the average annual cost of prescription drugs to treat a child with asthma in the US rose from $349 to $838 over a ten-year period. The AHRQ study looked at costs in 1997-98 compared to 2007-08. Over the same period, the average overall cost of treatment … [Read more...] about Asthma drug costs more than doubled for US children over a decade
Armstrong advises customers to stock up on Primatene Mist
Armstrong Pharmaceuticals is advising customers to stockpile its Primatene Mist epinephrine MDI before the FDA ban on CFC formulations takes effect on December 31, 2011. The company says that it is "actively finalizing its internal development" of an HFA formulation but warns that there is likely to be a period of time after the ban goes into effect before the new … [Read more...] about Armstrong advises customers to stock up on Primatene Mist