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FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation

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 season based on positive results of a new study in children aged 2-4 years old. FluMist Quadrivalent was approved by the … [Read more...] about FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation

Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension

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 ALIS and extends patent coverage for the formulation from January 2034 to May 2035. The patent covers the use of nebulized … [Read more...] about Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension

FDA accepts Acorda’s new NDA for Inbrija inhaled levodopa

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 is October 5, 2018. In August 2017, the FDA issued a refuse-to-file letter in response to Acorda's initial 505(b)(2 ) NDA … [Read more...] about FDA accepts Acorda’s new NDA for Inbrija inhaled levodopa

GSK submits type II variation application in Europe for expanded use of Trelegy Ellipta

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 in Europe in November 2017. In the US, the FDA initially approved Trelegy Ellipta for … [Read more...] about GSK submits type II variation application in Europe for expanded use of Trelegy Ellipta

Dauntless Pharmaceuticals gets orphan drug designation for intranasal octreotide

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 President and CEO Joel Martin commented, "The FDA's decision to grant DP1038 orphan drug designation for the … [Read more...] about Dauntless Pharmaceuticals gets orphan drug designation for intranasal octreotide

Aradigm receives CRL for Linhaliq

Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. An FDA advisory committee recently voted against recommending approval of the application. According to … [Read more...] about Aradigm receives CRL for Linhaliq

CHMP adopts positive opinion on Relvar Ellipta for additional indication

According to GlaxoSmithKline and Innoviva, the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding approval of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma that is adequately controlled with an inhaled corticosteroid and a LABA. The companies said that they expect to get the final … [Read more...] about CHMP adopts positive opinion on Relvar Ellipta for additional indication