PARI Pharma has received European marketing authorization for its Vantobra 170 mg tobramycin/1.7 ml inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older, the company said. Vantobra is delivered via the Tolero nebulizer and is packaged together with the device. PARI Pharma submitted the marketing authorization … [Read more...] about PARI Pharma’s Vantobra inhalation solution approved in Europe
News
Vectura appoints Per-Olof Andersson as Non-Executive Director
Respiratory drug developer Vectura has announced the appointment of former Almirall Executive Director of R&D Per-Olof Andersson as a Non-Executive Director of the Board. Before Almirall, he worked for almost two decades for Pharmacia and Pfizer. Andersson retired from Almirall in 2011 and has been working as an independent consultant since that time. Vectura … [Read more...] about Vectura appoints Per-Olof Andersson as Non-Executive Director
Shanghai Sine Promod Budesonide DPI incorporates Aptar’s Twister device
Aptar Pharma has announced that a new budesonide DPI launched in China by Shanghai Sine Promod Pharmaceutical is the first marketed product to incorporate Aptar's new Twister device. The new 200µg dose budesonide inhaler is available in 30 capsule and 60 capsule versions for the treatment of asthma. In April 2012, Aptar Pharma announced the availability of the … [Read more...] about Shanghai Sine Promod Budesonide DPI incorporates Aptar’s Twister device
Eklira Genuair approved in Japan
Kyorin Pharmaceutical has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its marketing application for the Eklira Genuair aclidinium bromide DPI for the treatment of COPD in 30 and 60 inhalation versions. Kyorin licensed Eklira Genuair from Almirall in February 2011. The company also markets SkyePharma's Flutiform … [Read more...] about Eklira Genuair approved in Japan
ProAir RespiClick gets FDA approval
The FDA has now approved Teva's ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 12 and older, the company said. Teva had announced tentative approval of the product, which was previously known as ProAir Spiromax, on March 5, 2015. Teva Senior VP, Global Respiratory R&D, Tushar Shah commented, "Teva is committed to optimizing … [Read more...] about ProAir RespiClick gets FDA approval
Insmed announces public stock offering to support Arikayce development
Insmed Incorporated has announced that it is offering 10 million shares of its common stock at $20.65 per share, which it expects to generate net proceeds of about $194 million. The company says that it will use the money for expenses related to Arikayce inhaled liposomal through commercialization, for further development of INS1009 inhaled treprostinil prodrug … [Read more...] about Insmed announces public stock offering to support Arikayce development
Par launches Nascobal single use cyanocobalamin nasal spray
Par Specialty Pharmaceuticals (formerly called Strativa Pharmaceuticals) has launched a single use version of Nascobal cyanocobalamin nasal spray for the treatment of pernicious anemia and other vitamin B12 deficiencies, the company said. The FDA approved the single dose, once-a-week product, which is packaged in cartons of four, in June 2014. The company also … [Read more...] about Par launches Nascobal single use cyanocobalamin nasal spray
Encruse Ellipta approved in Japan
According to GSK, the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved its Encruse Ellipta umeclidinium DPI for the treatment of COPD, and the company plans to launch the product in Japan sometime this year. The approved dosage is 62.5 mcg. GSK announced in May 2014 that it had filed the application for the inhaler, which is approved in the US … [Read more...] about Encruse Ellipta approved in Japan
Invion announces successful pre-IND meeting with FDA for inhaled nadolol
According to Invion Limited, the company "has received a positive response" from the FDA during a pre-IND meeting regarding its INV102 inhaled nadolol for the treatment of asthma and COPD. Invion is developing the drug in partnership with 3M Drug Delivery Systems, and the company said that the agency has accepted both the formulation and proprietary MDI technology … [Read more...] about Invion announces successful pre-IND meeting with FDA for inhaled nadolol
Verona says interim results from Phase 1/2 study of RPL554 look promising
Verona Pharma has announced what it calls "encouraging interim results" from a Phase 1/2 study of a new formulation of its RPL554 PDE3/4 inhibitor for the treatment of COPD exacerbations. The company had announced the initiation of the 120-subject study of the nebulized formulation in January 2015 and now says that the trial is ahead of schedule. According to … [Read more...] about Verona says interim results from Phase 1/2 study of RPL554 look promising