Regulatory

According to Vectura, the FDA has approved the company's investigational new drug (IND) application for VR647 nebulized budesonide, which the company is developing for the treatment of asthma in children aged 12 months to 8 years. VR647 is delivered by the Akita Jet smart nebulizer, a technology that Vectura acquired in 2014, when it acquired Activaero. … [Read more...] about FDA approves IND for Vectura’s VR647 nebulized budesonide

According to Pulmatrix, its PUR1900 itraconazole DPI for the treatment of pulmonary aspergillus infections in cystic fibrosis patients has received Qualified Infectious Disease Product (QIDP) designation from the FDA. Pulmatrix CEO Robert Clarke commented, "The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as … [Read more...] about Pulmatrix gets QIDP designation for PUR1900

Neurelis has announced that its NRL-1 intranasal diazepam has received Fast Track designation from the FDA for the treatment of acute repetitive or cluster seizures in epilepsy patients. The company plans to submit an NDA for the product by early 2018. The FDA granted NRL-1 orphan drug designation in 2015, and Neurelis announced the initiation of pivotal trials in … [Read more...] about Neurelis gets Fast Track designation for intranasal diazepam

Amphastar Pharmaceuticals subsidiary Armstrong Pharmaceuticals has received a complete response letter from the FDA in regard to its NDA for the Primatene Mist epinephrine inhaler, Amphastar has announced. The CRL said that the FDA would require an additional human factors validation study as well as label and packaging changes. The original version of Primatene … [Read more...] about Amphastar gets complete response letter for Primatene Mist

According to Cipla, its Sereflo fluticasone/salmeterol MDI, a generic version of Advair (Seretide), has been approved by the UK MHRA for the treatment of asthma, and the product will be launched by a partner in the UK within a few weeks. Cipla Ltd. Global CEO Umang Vohra commented, “We are extremely pleased with the approval of Sereflo in the UK. This is a … [Read more...] about Cipla’s Sereflo fluticasone/salmeterol MDI approved in UK

Easyhaler maker Orion Corporation has announced that it plans to submit a marketing authorization application in the EU for its salmeterol/fluticasone DPI for the treatment of asthma and COPD in the first half of 2017. The company said that its plan to submit the MAA is based on recently received positive results from a PK study. Orion Senior VP, Pharmaceutical … [Read more...] about Orion announces plan to submit MAA for salmeterol/fluticasone Easyhaler in 2017

In advertisements appearing in British nursing, pharmaceutical, and medical journals.the Prescription Medicines Code of Practice Authority (PMCPA), the administrator of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry, has called out AstraZeneca for misleading promotions of the Duaklir Genuair … [Read more...] about PMCPA accuses AstraZeneca of being misleading about Duaklir Genuair indications

Evoke Pharma says that it recently had a positive pre-NDA meeting with the FDA regarding clinical data to be included in its planned 505(b)(2) NDA for Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis in adult women. The meeting was the second regarding Gimoti. After the first meeting, Evoke announced that it planned to move ahead with … [Read more...] about Evoke Pharma reports positive pre-NDA meeting with FDA for intranasal metoclopramide

GlaxoSmithKline and Innoviva have announced that GSK has filed an MAA with the European Medicines Agency for its fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD. In November 2016, GSK submitted an NDA for the FF/UMEC/VI product in the US. GSK Head, Respiratory Therapy Area Unit, R&D, Dave Allen said, “Many patients with COPD are already … [Read more...] about GSK files regulatory submission for triple combination DPI in EU

GlaxoSmithKline and Innoviva have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the 100/25 mcg strength of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD. Both the 100/25 mcg and 200/25 mcg strengths of Relvar Ellipta have been approved in Japan for the treatment of asthma since 2013. GSK … [Read more...] about Relvar Ellipta approved in Japan for the treatment of COPD