Summit Biosciences has announced that it can now produce prescription nasal sprays for the the European market after receiving EU GMP certification from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its manufacturing facilities in Lexington, Kentucky. According to the company, Summit sought the certification "in anticipation of the European … [Read more...] about Nasal spray manufacturer Summit Biosciences gets GMP certificate from MHRA
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Adherium introduces SmartTurbo Model 4 monitoring device for Turbuhaler
Adherium has introduced the SmartTurbo Model 4 monitoring device for the Turbuhaler DPI. The new device includes design improvements for older patients including easier installation and removal of the inhaler and larger buttons. According to Adherium, the SmartTurbo Model 4 also has added sensors to improve feedback on correct use of the Turbuhaler. The company … [Read more...] about Adherium introduces SmartTurbo Model 4 monitoring device for Turbuhaler
Positive Phase 3 results for AstraZeneca’s Duaklir DPI for COPD
AstraZeneca has announced positive top-line from the Phase 3 AMPLIFY study of the Duaklir aclidinium bromide/formoterol DPI in patients with moderate to very severe COPD. The study met its primary endpoints by demonstrating statistically significant improvement in lung function for patients using Duaklir compared to the individual components and by demonstrating … [Read more...] about Positive Phase 3 results for AstraZeneca’s Duaklir DPI for COPD
Pulmatrix licenses PUR0200 dry powder tiotropium to Vectura
Pulmatrix has announced a licensing agreement with Vectura for US development of Pulmatrix's PUR0200 dry powder tiotropium formulation for the treatment of COPD. Vectura will pay Pulmatrix a $1 million "technology access fee" on achievement of certain milestones and will take responsibility for US development beginning immediately. According its own announcement, … [Read more...] about Pulmatrix licenses PUR0200 dry powder tiotropium to Vectura
Pulmatrix gets development award from Cystic Fibrosis Foundation Therapeutics for PUR1900
According to Pulmatrix, the Cystic Fibrosis Foundation Therapeutics (CFFT) will provide funds to support non-clinical development of PUR1900, an itraconazole DPI, for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in cystic fibrosis and asthma patients. The amount of the award was not specified by Pulmatrix; however, the CFFT website says that … [Read more...] about Pulmatrix gets development award from Cystic Fibrosis Foundation Therapeutics for PUR1900
Insmed to seek accelerated approval of ALIS based on positive Phase 3 study results
Now that the Phase 3 CONVERT study has met its primary endpoint of culture conversion with statistical and clinical significance by Month 6, Insmed said, the company plans to seek priority review and accelerated approval from the FDA for its ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacteria (NTM) lung infections The … [Read more...] about Insmed to seek accelerated approval of ALIS based on positive Phase 3 study results
Ascend Therapeutics now promoting Egalet’s Sprix nasal spray in the US
Ascend Therapeutics is now promoting Egalet's Sprix ketorolac tromethamine nasal spray for the treatment of moderate-to-moderately severe pain to women's healthcare providers in the US, Egalet said. According to Egalet, the companies signed the agreement allowing Ascend to promote the product in July 2017. Egalet Chief Commercial Officer Patrick Shea commented, … [Read more...] about Ascend Therapeutics now promoting Egalet’s Sprix nasal spray in the US
Adherium’s SmartTouch sensor for Symbicort gets 510(k) clearance
According to SmartInhaler maker Adherium, the FDA has granted 510(K) clearance for the company's SmartTouch sensor for use with AstraZeneca's Symbicort MDI. The SmartTouch device, which fits over the inhaler, records and transmits inhaler usage data via Bluetooth. Adherium CEO Arik Anderson commented, “The SmartTouch for Symbicort is the most advanced Smartinhaler … [Read more...] about Adherium’s SmartTouch sensor for Symbicort gets 510(k) clearance
Coalesce Product Development hires two former Vectura OINDP device experts
Device developer Coalesce Product Development has announced the appointments of Stephen Eason as Strategic Advisor and IP Consultant, and Mike Newton as Engineering Consultant. Both men have extensive experience in the development of OINDP devices. Eason led development of the Aspirair dry powder inhaler while at Cambridge Consultants and joined Vectura as Senior … [Read more...] about Coalesce Product Development hires two former Vectura OINDP device experts
Dance Biopharm buys back Asia license for Dance-501 inhaled insulin
Dance Biopharm announced that it has bought back the Asia license for its Dance-501 soft mist inhaled insulin by purchasing the license holder, Harmony Biopharm Limited, from Harmony Plus Holdings Limited (Harmony). Dance said that Harmony will receive stock and a percentage of future sales of the product in China and that Harmony will continue to advise Dance on … [Read more...] about Dance Biopharm buys back Asia license for Dance-501 inhaled insulin