Regulatory
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According to Hikma Pharmaceuticals, the FDA has concluded the dispute resolution process regarding HIkma’s ANDA for its generic version of the Advair fluticasone propionate/salmeterol DPI and has requested a new clinical study. The FDA issued… Read more . . .
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Aradigm has submitted a marketing authorization application to the EMA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. In… Read more . . .
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A Type II variation application for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI in patients whose asthma is adequately controlled by an ICS/LABA combination has been approved by the EC, according to GSK… Read more . . .
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Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices… Read more . . .
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AstraZeneca has announced that the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of FluMist Quadrivalent intranasal live Influenza vaccine for the 2018-19 flu… Read more . . .
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The US Patent and Trademark Office has issued US Patent Number 9,895,385, titled “Methods for treating pulmonary non-tuberculous mycobacterial infections” to Insmed Incorporated, the company said. According to Insmed, the patent is the 9th for… Read more . . .
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The FDA has accepted Acorda Therapeutics’ revised NDA for Inbrija inhaled levodopa for the treatment of symptoms associated with OFF periods in Parkinson’s disease in patients taking carbidopa/levodopa, the company said. The PDUFA target date… Read more . . .
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GlaxoSmithKline and Innoviva have announced the submission of a type II variation application seeking expanded use for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI for the treatment of COPD. Trelegy Ellipta was granted marketing authorization… Read more . . .
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According to Savara, the FDA has approved an IND the company submitted for Molgradex, an inhaled molgramostim (recombinant human GM-CSF) formulation for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), which the company filed in… Read more . . .
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The FDA has granted orphan drug designation to Dauntless Pharmaceuticals’ DP1038 intranasal octreotide acetate for the treatment of acromegaly, the company said. Dauntless announced positive Phase 1 results for DP1038 in May 2015. Dauntless Pharmaceuticals… Read more . . .
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