According to Marinomed, the company's Coldamaris anti-virus nasal spray has been approved in Canada as a "natural health product." The over-the-counter product has been registered in Europe, where it is licensed to Boehringer Ingelheim, since 2007. Coldamaris, which contains a red algae extract called Carragelose, is approved in 38 countries as a prophylactic and … [Read more...] about Marinomed gets Canadian approval for anti-virus nasal spray
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Pharma Tech selected for dry powder intranasal product
OptiNose has selected Pharma Tech Industries (PTI) to fill capsules, load cartridges, and package completed delivery systems for NDA batches of its dry powder intranasal sumatriptan, according to Pharma Tech. In November 2012, OptiNose announced positive results from a Phase 3 study of the product, which is delivered using the company's bi-directional nasal device. … [Read more...] about Pharma Tech selected for dry powder intranasal product
Developer of nasal spray for traumatic brain injury gets funding
Prevacus, Inc., a 2012 spin-out from Florida State University, has entered into an agreement with The Institute for the Commercialization of Public Research for funding to support clinical development of Prevasol nasal spray. According to the company, Prevasol "utilizes Neurosteroids to improve behavioral outcomes of brain injury (working memory, sensory … [Read more...] about Developer of nasal spray for traumatic brain injury gets funding
Savara announces clinical advisory board
According to Savara Pharmaceuticals, the company has created a Clinical Advisory Board to provide advice on the development of AeroVanc vancomycin hydrochloride inhalation powder for the treatment of MRSA lung infections in patients with cystic fibrosis. The five members of the new board are: Michael P. Boyle, Associate Professor of Medicine and Director of the … [Read more...] about Savara announces clinical advisory board
Asthmapolis wins Bluetooth Breakthrough Award
The Bluetooth Special Interest Group (SIG) has named Asthmapolis the winner in the Product Category of the Bluetooth Breakthrough Awards. The awards recognize innovative products and apps that use Bluetooth wireless technology. Asthmapolis, which uses inhaler sensors and mobile apps to transmit and track data on patient use of inhalers, was one of five finalists for … [Read more...] about Asthmapolis wins Bluetooth Breakthrough Award
Nexus6 gets more than $4 million in funding for Smartinhaler
Smartinhaler developer Nexus6 has raised NZ$1.6 million (US$1.34 million) from existing investors plus NZ$3 (US$2.5 million) from BioScience Managers, with additional funding expected to bring the total to NZ$5 million by the close of the round in March. The company says it will use the money to expand global sales and marketing of the Smartinhaler range of inhaler … [Read more...] about Nexus6 gets more than $4 million in funding for Smartinhaler
Chiesi looks to acquire Cornerstone Therapeutics
According to North Carolina-based Cornerstone Therapeutics, Chiesi Farmaceutici has offered to purchase shares of Cornerstone's common stock for between $6.40 and $6.70 per share, to take the company private. Chiesi already owns approximately 60% of the outstanding shares of Cornerstone's common stock. No decision has been made by Cornerstone's board of directors at … [Read more...] about Chiesi looks to acquire Cornerstone Therapeutics
FDA accepts NDA for Anoro Ellipta DPI
According to GSK and Theravance, the FDA has accepted their NDA for the Anoro Ellipta umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD, with a PDUFA date of December 18, 2013. The two companies submitted the NDA in December 2012. GSK and Theravance also submitted an MAA for Anoro earlier this year, and that application has … [Read more...] about FDA accepts NDA for Anoro Ellipta DPI
Quintiles to go public again
CRO Quintiles says that it has filed a registration statement with the US. Securities and Exchange Commission (SEC) for an initial public offering (IPO) of an undisclosed number of shares of common stock. The company says that it plans to use the proceeds to pay down debt and "for general corporate purposes." Quintiles previously went public in 1994, then went private … [Read more...] about Quintiles to go public again
Next Breath receives ISO/IEC 17025:2005 accreditation
The American Association for Laboratory Accreditation (A2LA) has accredited Next Breath, LLC, to ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) 17025:2005a, the primary standard for testing and calibration labs. Next Breath offers a wide range of analytical testing services for OINDPs. Next Breath … [Read more...] about Next Breath receives ISO/IEC 17025:2005 accreditation