Senzer Pharmaceuticals has announced the launch of a new Critical Care Division for development of two inhaled anti-viral drugs for the treatment of COVID-19. The company did not specify which drugs it planned to develop but did say that the formulations would be delivered via MDI rather than with its SIDD (Systemic Inhaled Delivery Device), which is used for its … [Read more...] about Senzer to develop inhaled antivirals for the treatment of COVID-19
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Glenmark launches Airz-FF triple combination inhaler for COPD in India
Glenmark Pharmaceuticals has announced the launch of its Airz-FF glycopyrronium/formoterol/fluticasone propionate triple combination inhaler for the treatment of COPD in India. The company said that "AIRZ-FF has been exclusively studied in the Indian population and introduced to address challenges faced by a significant portion of COPD patients in the … [Read more...] about Glenmark launches Airz-FF triple combination inhaler for COPD in India
Phase 3 trial of Oyster Point’s OC-01 varenicline nasal spray for dry eye meets primary endpoint
Oyster Point Pharma has announced that the Phase 3 ONSET-2 trial of the company's OC-01 varenicline nasal spray for the treatment of dry eye disease met its primary endpoint, demonstrating significant improvement in tear film production as measured by Schirmer's score for more patients using OC-01 than for patients using a control. A number of secondary endpoints were … [Read more...] about Phase 3 trial of Oyster Point’s OC-01 varenicline nasal spray for dry eye meets primary endpoint
iCAIR consortium initiates project to develop inhaled drugs for COVID-19
A consortium called Fraunhofer International Consortium for Anti-Infective Research (iCAIR) -- composed of researchers from Fraunhofer ITEM, Griffith University, Hannover Medical School, and Twincore -- has announced that it has initiated a project to develop inhaled drugs to treat COVID-19, starting with high-throughput screening for candidates by temporary … [Read more...] about iCAIR consortium initiates project to develop inhaled drugs for COVID-19
Proveris Scientific now offering cGMP compliant laboratory services for OINDPs
Spray characterization specialist Proveris Scientific has announced that it is now offering contract testing services for OINDP regulatory submissions, release testing and stability studies, as well as for development projects. The company received ISO 9001:2015 certification in 2018, and the laboratory now also meets cGMP requirements for both the FDA and the … [Read more...] about Proveris Scientific now offering cGMP compliant laboratory services for OINDPs
Pulmotect gets FDA okay for two Phase 2 trials of PUL-042 for the prevention and treatment of COVID-19
Pulmotect said that it plans to initiate two Phase 2 trials of its PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19 within a week after getting the go-ahead from the FDA. In January 2020, the company announced that preclinical studies of PUL-042, which is made up of Toll-like receptor agonists, demonstrated that it could protect … [Read more...] about Pulmotect gets FDA okay for two Phase 2 trials of PUL-042 for the prevention and treatment of COVID-19
FDA approves IND for Phase 2 study of GeneOne Life Science nasal spray for the prevention of COVID-19
The FDA has approved an IND for a Phase 2 study of GeneOne Life Science's GLS-1200 nasal spray for the prevention of COVID-19, the company said. According to GeneOne, GLS-1200 stimulates nasal production of nitric oxide, which has been shown to inhibit coronavirus activity. The study of GLS-1200 for prevention of COVID-19 is expected to enroll 225 healthcare … [Read more...] about FDA approves IND for Phase 2 study of GeneOne Life Science nasal spray for the prevention of COVID-19
Impel NeuroPharma Chairman Adrian Adams takes over CEO role as Jon Congleton steps down
Impel NeuroPharma has announced the resignation of Jon Congleton as President and CEO; Adrian Adams, who was appointed as Impel's Chairman of the Board of Directors in January 2020, will now add the CEO role. Adams has previously served as CEO of a number of pharmaceutical companies, including Aralez, Auxilium, Neurologix, Inspire Pharmaceuticals, Sepracor, and Kos. … [Read more...] about Impel NeuroPharma Chairman Adrian Adams takes over CEO role as Jon Congleton steps down
Iconovo says Amneal will take over development of ICOres-based generic Symbicort
DPI developer Iconovo has announced that Amneal will take over development of a generic version of Symbicort based on Iconovo's multi-dose ICOres device. Iconovo and Amneal initially signed a licensing and development deal in 2016. In March 2019, Iconovo had announced that Mumbai-based CBC Corporation would handle development of the DPI. According to the new … [Read more...] about Iconovo says Amneal will take over development of ICOres-based generic Symbicort
AAAAI publishes new data showing bioequivalence of ARS Pharmaceuticals’ ARS-1 epinephrine nasal spray to injected epinephrine
The American Academy of Allergy, Asthma & Immunology (AAAAI) has published results of three Phase 1 studies of ARS Pharmaceuticals' ARS-1 (Neffy) intranasal epinephrine that had been scheduled for presentation at the AAAAI annual meeting. The FDA granted Fast Track designation to the ARS-1 for the treatment of anaphylaxis in February 2019. The studies, EPI … [Read more...] about AAAAI publishes new data showing bioequivalence of ARS Pharmaceuticals’ ARS-1 epinephrine nasal spray to injected epinephrine