A PD study has shown no statistically significant difference in pulmonary artery pressure effects of Levadex inhaled dihydroergotamine (DHE) compared to placebo, according to MAP Pharmaceutical. The inhaled formulation had a smaller effect on pulmonary artery pressure than IV DHE. MAP has said that it intends to submit an NDA for Levadex for the treatment of … [Read more...] about MAP announces Levadex trial results
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Prosonix launches co-crystal services
Prosonix has announced the availability of a new co-crystal development and processing service using its ultrasound technology for the manufacture of co-crystal APIs for inhalation products. According to the company, the process creates co-crystals with improved solubility and particle size distribution control. Read the company's press release. … [Read more...] about Prosonix launches co-crystal services
Marketing authorization for PecFent nasal spray
According to Archimedes Pharma, the European Commission has granted marketing authorization for the company's PecFent fentanyl nasal spray for the treatment of breakthrough pain in adult cancer patients. Archimedes submitted an NDA for the product to the US FDA in 2009 and is waiting for US approval. Read the company's press release. … [Read more...] about Marketing authorization for PecFent nasal spray
Quintiles to support Bronchitol commercialization
Quintiles has announced that it will provide commercialization services to Pharmaxis for the launch of Pharmaxis's Bronchitol mannitol DPI for the treatment of Cystic Fibrosis. Bronchitol has received orphan drug status in both Europe and the US, and Pharmaxis has filed an MAA with the EMA. Read the company's press release. … [Read more...] about Quintiles to support Bronchitol commercialization
Cypress Bioscience licenses two OINDPs
Cypress Bioscience of San Diego, California has aquired worldwide licensing rights for Alexza Pharmaceutical's Staccato Nicotine inhaler for smoking cessation. Alexza will receive $5 million up front, with another $1 million due upon meeting preclinical and clinical milestones. Read the company's press release. Cypress also announced that it purchased … [Read more...] about Cypress Bioscience licenses two OINDPs
Abbott terminates Flutiform agreement with Skye
Skye Pharma says that it understands why Abbot has decided to return US marketing rights for the Flutiform formoterol fluticasate MDI given the issues raised by the US FDA concerning approval of the drug. According to Skye, it will look for a new licensee if the company can find a way to move forward with the NDA. Read the company's press release. … [Read more...] about Abbott terminates Flutiform agreement with Skye
Archimedes to open US headquarters in New Jersey
Archimedes Pharma, which has submitted an NDA for its lead product, PecFent fentanyl nasal spray, announced that it anticipates creating as many as 75 new jobs at its new US headquarters in Bedminster, NJ. The company's main headquarters are in Reading, UK. Read the company's press release. … [Read more...] about Archimedes to open US headquarters in New Jersey
MannKind announces $110 million stock agreement
MannKind Corporation, which is waiting for FDA approval of its Afrezza inhaled insulin, announced that it hopes to raise up to $110 million by lending 9 million shares of its stock to Bank of America. Merrill Lynch will then sell the borrowed shares, shorting the stock, and will use the proceeds in conjunction with a private offering of MannKind Senior Convertible … [Read more...] about MannKind announces $110 million stock agreement
Cannabis Science and Smokefree Innotec sign development agreement
Cannabis Science and Smokefree Innotec will co-develop pharmaceutical cannabis products for inhalation. Smokefree Innotec, which manufactures electronic cigarettes, will develop the devices, with Cannabis Science developing the formulations. Read the company's press release … [Read more...] about Cannabis Science and Smokefree Innotec sign development agreement
Alexza hires new VP, Quality
Alexza has hired Darl Moreland as its new Vice President, Quality. Moreland was previously VP, Quality Assurance and Compliance and Chief Compliance officer for Mentor Worldwide. At Alexza, he will be responsible for quality assurance, quality control, and quality system regulatory compliance. Read the company's press release. … [Read more...] about Alexza hires new VP, Quality