Impel NeuroPharma has announced the initiation of the Phase 2a THOR 201 study of INP103 intranasal levodopa compared to placebo for the treatment of OFF episodes in Parkinson's disease patients. INP103 is delivered by Impel's Precision Olfactory Delivery (POD) device. The safety and PK/PD study is expected to enroll 24 patients who will receive one of 3 doses of … [Read more...] about Impel NeuroPharma initiates Phase 2a study of INP103 intranasal levodopa for Parkinson’s disease
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Apotex recalls lot of fluticasone nasal spray in US
Apotex has issued a voluntarily recall for one lot of fluticasone propionate nasal spray (lot NJ4501), which was shipped to wholesalers and distributors throughout the US and has an expiration date of July 2020. Apotex said that the FDA is aware of the recall and wholesalers and distributors have been notified. According to the company, a consumer complaint … [Read more...] about Apotex recalls lot of fluticasone nasal spray in US
Australian Pharmaceutical Benefits Scheme to reimburse for Trelegy Ellipta
GSK Australia has announced that the Australian Pharmaceutical Benefits Scheme (PBS) will reimburse for Trelegy Ellipta for the treatment of moderate to severe COPD as of June 1, 2018. According to a document on the Therapeutic Goods Administration (TGA) website, Trelegy Ellipta was entered into the Australian Register of Therapeutic Goods as of January 16, 2018. … [Read more...] about Australian Pharmaceutical Benefits Scheme to reimburse for Trelegy Ellipta
Copley Scientific launches new accessories for DDU and APSD testing of nebulizers with facemasks
Copley Scientific has announced the launch of a new Facemask Test Stand (FMS) to facilitate delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing of nebulizers with face masks for Quality by Design and bioequivalence studies. The FMS allows a nebulizer with face mask to interface securely with a standard DDU filter holder … [Read more...] about Copley Scientific launches new accessories for DDU and APSD testing of nebulizers with facemasks
Propeller Health partners with Aptar Pharma, raises $20 million
Inhaler monitoring company Propeller Health has announced that its latest funding round included $10 million from device company Aptar Pharma, with an additional $10 million total from existing investors Safeguard Scientifics, Social Capital, Hikma, 3M Ventures and SR One. In 2016, Propeller and Aptar announced that they would co-develop a connected MDI. The … [Read more...] about Propeller Health partners with Aptar Pharma, raises $20 million
Savara announces good results for Molgradex treatment in two CF patients with NTM lung infections
Savara has updated two case reports published in the European Respiratory Journal in April 2018 that describe the treatment of nontuberculous mycobacterial (NTM) lung infection Mycobacterium abscessus using Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with cystic fibrosis. M. abscessus is a multidrug … [Read more...] about Savara announces good results for Molgradex treatment in two CF patients with NTM lung infections
GSK submits marketing application for Trelegy Ellipta in Japan
GSK and Innoviva have announced that an NDA for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW). Trelegy Ellipta was approved in the US and in Europe for the treatment of COPD in 2017 and was approved in Canada earlier this year. The FDA … [Read more...] about GSK submits marketing application for Trelegy Ellipta in Japan
Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Vast Therapeutics, which recently changed its name from Novoclem Therapeutics, has announced that its BIOC51 dry powder nitric oxide (NO)-release formulation reduced the bacterial load of nontuberculous mycobacteria (NTM) in the lungs of mice by 99% in a study conducted with Colorado State University. According to the company, BIOC51 has eradicated every bacterial … [Read more...] about Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study
Windtree Therapeutics has received the remaining $700,000 from a Small Business Innovation Research Grant (SBIR) from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) that was initially awarded in 2016 for Phase 2 development of Aerosurf. The company previously received a total of $1.9 million from that award, an … [Read more...] about Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study
Sava Healthcare gets Russian GMP approval for Indian DPI capsule manufacturing line
Indian pharma company Sava Healthcare has announced that its DPI capsule manufacturing line has received approval from the Russian Ministry of Health (MOH). Sava said that it manufactures tiotropium, formoterol, salmeterol/fluticasone, and budesonide/formoterol DPIs for the Russian and CIS markets. According to Sava, its Surendranagar facility, which also … [Read more...] about Sava Healthcare gets Russian GMP approval for Indian DPI capsule manufacturing line