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
Regulatory
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
Acorda gets refusal to file letter for Inbrija inhaled L-dopa NDA
Acorda Therapeutics has received a refusal to file letter from the FDA in response to its NDA for Inbrija (CVT-301) inhaled levodopa for the treatment of OFF periods in Parkinson’s disease patients, the company said. Acorda submitted the 505(b)(2) NDA in June 2017. According to the company, the FDA letter said that the NDA lacked sufficient information for review, … [Read more...] about Acorda gets refusal to file letter for Inbrija inhaled L-dopa NDA
Altimmune submits IND for NasoVax
Altimmune has submitted an investigational new drug application to FDA for its NasoVAX intranasal flu vaccine and is planning a Phase 2 study of the product, the company said. The safety and immunogenicity study is anticipated to enroll 60 volunteers, with data available in early 2018, and is expected to be followed by a larger immunogenicity study for a quadrivalent … [Read more...] about Altimmune submits IND for NasoVax
Chiesi’s triple combination Trimbow MDI approved in EU
The European Commission has approved Chiesi's Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI for the treatment of COPD in patients for whom an ICS/LABA combination is insufficient to control symptoms and prevent exacerbations, the company said. The EMA’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive … [Read more...] about Chiesi’s triple combination Trimbow MDI approved in EU
Teva’s QVAR RediHaler approved by the FDA
The FDA has approved 40μg and 80μg strengths of Teva's QVAR RediHaler beclomethasone dipropionate breath-actuated MDI for treatment of asthma in patients aged 4 and older, the company said. Teva said that it expects to launch the product in the US in the first quarter of 2018. The current version of QVAR, which added a dose counter, was approved by the FDA in 2014. … [Read more...] about Teva’s QVAR RediHaler approved by the FDA
Insmed’s inhaled liposomal amikacin gets established name
The FDA has designated the established name for Insmed's inhaled amikacin, which is in Phase 3 development for the treatment of nontuberculous mycobacteria (NTM) lung infections, as "amikacin liposome inhalation suspension," the company said in a business update. Insmed has previously called its amikacin suspension Arikayce and is now referring to the product as … [Read more...] about Insmed’s inhaled liposomal amikacin gets established name
Indivior’s Nalscue naloxone nasal spray approved in France
According to Indivior, the French regulatory agency Agence nationale de sécurité du médicament et des produits de santé (ANSM) has approved the company's MAA for Nalscue naloxone hydrochloride nasal spray for the reversal of opioid overdose. Nalscue had been available in France under a Temporary Authorization for Use since July 2016. Indivior Chief Medical Officer … [Read more...] about Indivior’s Nalscue naloxone nasal spray approved in France
Aradigm submits NDA for Linhaliq (formerly Pulmaquin) for non-cystic fibrosis bronchiectasis
Aradigm Corporation has filed a new drug application to for Linhaliq inhaled ciprofloxacin (formerly Pulmaquin) for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), the company said. The company said that the NDA is supported by positive data from the Phase 3 ORBIT-3 and ORBIT-4 studies. In 2014, … [Read more...] about Aradigm submits NDA for Linhaliq (formerly Pulmaquin) for non-cystic fibrosis bronchiectasis
GSK files sNDA for Arnuity Ellipta
GSK has filed a supplementary NDA for approval of a 50mcg once-daily dose of the Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11. The FDA approved 100mcg and 200mcg doses of Arnuity Ellipta for the treatment of asthma in patients aged 12 and over in August 2014. According to GSK, the sNDA includes data from a 12-week … [Read more...] about GSK files sNDA for Arnuity Ellipta