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FDA accepts Liquidia’s NDA resubmission for LIQ861 dry powder treprostinil

According to Liquidia, the FDA has accepted the company's resubmitted NDA for LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension and has set a PDUFA goal date of November 7, 2021. Liquidia initially submitted the 505(b)(2) NDA in January 2020; the agency accepted the submission in April 2020 and then issued a complete response letter to the … [Read more...] about FDA accepts Liquidia’s NDA resubmission for LIQ861 dry powder treprostinil

Proveris hires Maria L. Smith to head up business development for Proveris Laboratories

Aerosol testing specialist Proveris Scientific has named Maria L. Smith as Director, Application and Business Development for Proveris Laboratories. Smith has extensive experience in OINDP spray characterization, first at DPT Laboratories and then at Renaissance Lakewood. In addition to business development for the lab, she is expected to "serve as a liaison to … [Read more...] about Proveris hires Maria L. Smith to head up business development for Proveris Laboratories

Adherium appoints new CEO, submits 510(k) application for next generation Hailie sensor after rejecting takeover bid

Inhaler monitoring company Adherium has submitted a 510(k) application for a new Hailie sensor designed to work with the Symbicort MDI the company announced. The company recently rejected a takeover bid from another Australian asthma monitoring company called Respiri and then named a new CEO, its sixth chief executive since 2017, saying that it "must continue … [Read more...] about Adherium appoints new CEO, submits 510(k) application for next generation Hailie sensor after rejecting takeover bid

Noveome signs agreement for commercial use of SipNose intranasal device for delivery of ST266

Noveome Biotherapeutics has signed a commercial license agreement for the use of SipNose’s intranasal Cribriform Targeted Device (CT6) for delivery of its ST266 secretome for the treatment of ophthalmological and CNS conditions the companies said. Noveome has been working with SipNose since 2015 and used the device in a Phase 1 trial of ST266 for optic nerve disease … [Read more...] about Noveome signs agreement for commercial use of SipNose intranasal device for delivery of ST266

FDA sets goal date for review of Lannet’s ANDA for generic of Advair Diskus

According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent's generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of asthma and COPD. The submission of the ANDA was announced in April 2021 by Lannett, which acquired US rights to the generic version of … [Read more...] about FDA sets goal date for review of Lannet’s ANDA for generic of Advair Diskus

AIM Immunotech extends deal with Smoore related to development of inhaled Ampligen

AIM ImmunoTech said that it has extended a 2020 agreement with Shenzhen Smoore Technology related to development of an inhaled version of its Ampligen rintatolimod for the treatment of COVID-19. The agreement with Smoore is for the use of a Smoore-designed "personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA." According to … [Read more...] about AIM Immunotech extends deal with Smoore related to development of inhaled Ampligen

EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients

The EMA’s COVID-19 task force has said "that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19." In addition, the task force said that "it could not exclude the possibility of harm from the use of inhaled corticosteroids in patients with COVID-19 who have normal levels of oxygen." Evidence cited by the … [Read more...] about EMA says there is insufficient evidence that treatment with ICS can benefit COVID-19 patients

Inhalon Biopharma gets US Army contract for development of inhaled antibody for the treatment of COVID-19

According to North Carolina-based startup Inhalon Biopharma, the US Army Medical Research & Development Command (USAMRDC) has awarded the company a contract worth $7 million for a Phase 1/2a study of its IN-006 inhaled neutralizing monoclonal antibody for the treatment of COVID-19 in an outpatient setting. The company expects topline results to be available in … [Read more...] about Inhalon Biopharma gets US Army contract for development of inhaled antibody for the treatment of COVID-19

Inhalation Sciences gets approval for PreciseInhale trial

The Swedish Medical Product Agency (Läkemedelsverket) has approved an application from Inhalation Sciences (ISAB) for a clinical trial of its PreciseInhale aerosol generation system, the company said. ISAB expects to initiate the trial in June 2021 and to complete the study by the end of the year. Inhalation Sciences first announced its intentions to validate … [Read more...] about Inhalation Sciences gets approval for PreciseInhale trial