The European Patent Office has granted Evoke Pharma patent no. 2376075 for its EVK-001 intranasal metoclopramide for the treatment of diabetic gastroparesis symptoms in women, the company said. Earlier this year, Evoke announced that Phase 3 development of EVK-001 has been delayed by slower than expected enrollment in an ongoing clinical trial. Evoke President and … [Read more...] about Evoke Pharma’s intranasal metoclopramide formulations get European patent
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Aptar Pharma gets license for preservative free multidose nasal devices in China
Aptar Pharma has announced that the Chinese State Food and Drug Administration (SFDA) has issued the company an import license for its preservative-free multi-dose opthalmic and nasal devices in accordance with regulations that require “Examination and approval for packaging materials and containers in direct contact with drugs” prior to marketing. Aptar's APF … [Read more...] about Aptar Pharma gets license for preservative free multidose nasal devices in China
PARI Pharma’s Vantobra inhalation solution approved in Europe
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
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