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
News
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
Discovery Labs gets $30 million for development of respiratory distress syndrome therapies
Discovery Laboratories says that Deerfield Management Company will provide the company up to $30 million in the form of a secured loan facility. Discovery Labs will use the money for development and commercialization of its Surfaxin lucinactant for the prevention of respiratory distress syndrome (RDS) in infants and Aerosurf aerosolized surfactant for the treatment of … [Read more...] about Discovery Labs gets $30 million for development of respiratory distress syndrome therapies
Critical reports positive results for intranasal growth hormone study
According to Critical Pharmaceuticals, a Phase 1b study has shown that its CP024 dry powder intranasal human growth hormone (hGH) was well tolerated with only a few minor adverse effects and showed a linear dose response. CP024 also induced production of therapeutic levels of insulin-like growth factor (IGF-1), making it the first nasal formulation of growth hormone … [Read more...] about Critical reports positive results for intranasal growth hormone study
MeadWestvaco expands preservative-free product manufacturing capacity
MeadWestvaco has announced a $7.5 million expansion of its pharmaceutical manufacturing Centre of Excellence in Hemer, Germany, an expansion the company attributes largely to growth in the preservative-free nasal product market. According to the company, the project includes additional capacity in clean room molding and assembly. MWV offers a number of spray pumps for … [Read more...] about MeadWestvaco expands preservative-free product manufacturing capacity
Prosonix names Cécile Miles as Chief Business Officer
Inhaled pharmaceutical company Prosonix has hired Cécile Miles as its Chief Business Officer. She had been Commercial Director, Europe for the Arrow Group, part of Watson (now Actavis) since May 2011. Prior to Arrow, she had worked in various capacities at Ark Therapeutics, PLIVA, Ranbaxy, and Fisons. Miles said, "I am very excited to be joining the Prosonix team … [Read more...] about Prosonix names Cécile Miles as Chief Business Officer
NEONC announces planned trial of intranasal therapy for brain cancer
California-based NEONC Technologies has announced plans for clinical trials of its NEO100 intranasal formulation of monoterpene perillyl alcohol (POH) for the treatment of gliomas and other CNS cancers. NEONC Chairman and CEO Thomas Chen, who is also Co-Director of the USC/Norris Neuro-Oncology Program and Professor of Neurological Surgery and Pathology at USC's Keck … [Read more...] about NEONC announces planned trial of intranasal therapy for brain cancer
Mystic gets US patent for intranasal delivery technology
The US Patent and Trade Office (USPTO) has granted Mystic Pharmaceuticals US Patent No. 8,377,009, according to the company. The patent, titled “Intranasal Cartridge Devices,” covers technology for a delivery system based on Mystic's unit dose delivery platforms for liquid or dry intranasal formulations of drugs and biologics. Mystic President and CEO Timothy … [Read more...] about Mystic gets US patent for intranasal delivery technology
Malvern Instruments offers particle characterization webinar series
Malvern Instruments has announced the launch of an Imaging Masterclass webinar series beginning February 26 and continuing throughout 2013. The company is also running a Laser Diffraction Masterclass series that covers wet and dry method development, optical property selection, and specification setting. According to the company, the initial session of the Imaging … [Read more...] about Malvern Instruments offers particle characterization webinar series