Regulatory
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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… Read more . . .
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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… Read more . . .
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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.… Read more . . .
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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… Read more . . .
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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.… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
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