Lupin has launched its generic version of Tobi inhalation solution in the US, the company said. The FDA granted final approval of Lupin's ANDA for its tobramycin inhalation inhalation solution in March 2017. The 300 mg/5 ml inhalation solution is indicated for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. Read the Lupin press … [Read more...] about Lupin launches generic tobramycin inhalation solution in US
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Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint
MannKind Corporation has announced that a previously announced Phase 1 study of its Treprostinil Technosphere (TreT) DPI in healthy volunteers has met its primary endpoint of safety and tolerability, and the company is now preparing for a study in patients with pulmonary arterial hypertension (PAH). According to the company, data from the study, which … [Read more...] about Phase 1 study MannKind’s Treprostinil Technosphere for PAH achieves primary endpoint
Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Spyryx Biosciences has announced that data from the first cohort of the Phase 2 HOPE-1 (Hydration for Optimal Pulmonary Effectiveness) study, which was initiated in October 2017, demonstrate improvement in lung function for cystic fibrosis patients independent of type of CF mutation after treatment with SPX-101, an inhaled SPLUNC1-derived peptide. The 46 patients … [Read more...] about Spyryx announces encouraging data from ongoing Phase 2 study of SPX-101 for CF
Evoke submits NDA for Gimoti metoclopramide nasal spray for diabetic gastroparesis
Evoke Pharma has submitted a 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, the company said. Earlier this year, Evoke announced that it had amended its deal with Mallinckrodt to defer milestone payments due on acceptance of review of the Gimoti NDA on final approval, with a single … [Read more...] about Evoke submits NDA for Gimoti metoclopramide nasal spray for diabetic gastroparesis
Pivot Pharmaceuticals signs option agreement for Trivair device for delivery of dry powder cannabinoid formulations
Pivot Pharmaceuticals has announced that the company signed an option agreement with IP Med Inc. for an exclusive worldwide license for use of TriVair nasal and pulmonary breath-propelled devices for delivery of dry powder cannabinoid formulations. Pivot will have 6 months to evaluate the use of the device for delivery of its Ready-To-Infuse-Cannabis ("RTIC") to … [Read more...] about Pivot Pharmaceuticals signs option agreement for Trivair device for delivery of dry powder cannabinoid formulations
Impel NeuroPharma initiates Phase 2a study of INP103 intranasal levodopa for Parkinson’s disease
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
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