VistaGen Therapeutics has announced that it is proposing a Phase 2a study of its PH94B aloradine nasal spray for the treatment of patients with adjustment disorder with anxiety caused by the COVID-19 pandemic, subject to approval by the FDA. The company said that it submitted the proposal through the FDA's Coronavirus Treatment Acceleration Program (CTAP). PH94B … [Read more...] about VistaGen proposes Phase 2a study of PH94B nasal spray for the treatment of anxiety related to the COVID-19 pandemic
Regulatory
Verona moving ahead with planning for Phase 3 study of nebulized ensifentrine after receipt of FDA comments
Verona Pharma says that the FDA's comments in response to the data from a Phase 2 study of the company's RPL554 nebulized ensifentrine for the treatment of COPD support moving ahead with a Phase 3 clinical program. The Phase 3 program, called ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy), is planned for later this year. In January 2020, Verona … [Read more...] about Verona moving ahead with planning for Phase 3 study of nebulized ensifentrine after receipt of FDA comments
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
CHMP recommends approval of Enerzair Breezhaler for the treatment of asthma
At its April 2020 meeting, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Enerzair Breezhaler (QVM149) indacaterol / glycopyrronium / mometasone for the treatment of uncontrolled asthma as well as for a duplicate inhaler, Zimbus Breezhaler. Novartis partners Vectura and Sosei announced in May 2019 that … [Read more...] about CHMP recommends approval of Enerzair Breezhaler for the treatment of asthma
FDA tentatively approves Lupin’s generic arformoterol tartrate inhalation solution
According to Lupin, the FDA has tentatively approved the company's arformoterol tartrate inhalation solution, a generic version of Sunovion's Brovana, for the treatment of COPD. Sunovion's final patent covering Brovana expires in November 2021. Brovana was originally approved by the FDA for the treatment of COPD in 2006. A post-marketing study commitment required … [Read more...] about FDA tentatively approves Lupin’s generic arformoterol tartrate inhalation solution
Zambon’s inhaled liposomal cyclosporine A for bronchiolitis obliterans gets Fast Track designation
According to Zambon, the FDA has granted Fast Track designation to the company's liposomal cyclosporine A for inhalation (L‑CsA‑i), which is in Phase 3 development for the treatment of bronchiolitis obliterans syndrome (BOS). Zambon acquired L‑CsA‑i developer Breath Therapeutics, a spin off of PARI Pharma, in July 2019. L-CsA-i has already received orphan drug … [Read more...] about Zambon’s inhaled liposomal cyclosporine A for bronchiolitis obliterans gets Fast Track designation
FDA approves Aurobindo’s generic albuterol sulfate inhalation solution, cites “increased demand” for albuterol inhalers due to COVID-19
The FDA has approved an Aurobindo ANDA for generic albuterol (salbutamol) sulfate inhalation solution and, while the agency did not issue a press release, the news was included in the FDA's COVID-19 "Daily Roundup" and was promoted by agency social media accounts. Although the FDA does not currently list albuterol sulfate inhalation solution on its drug shortages … [Read more...] about FDA approves Aurobindo’s generic albuterol sulfate inhalation solution, cites “increased demand” for albuterol inhalers due to COVID-19
Beyond Air to initiate trial of its LungFit iNO system for COVID-19
According to Beyond Air, the company has received permission from the FDA to initiate a clinical study of its LungFit inhaled nitric oxide system for the treatment of COVID-19 patients. The announcement comes almost a month after the company said that it had submitted an investigational device exemption application to the FDA for that purpose. The company said that it … [Read more...] about Beyond Air to initiate trial of its LungFit iNO system for COVID-19
FDA issues EUA allowing B. Braun infusion pumps to be used with nebulizers
German medical device company B. Braun Medical announced that the FDA has issued Emergency Use Authorization (EUA) of several of the company's infusion pumps for "tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having the Coronavirus Disease 2019 (COVID-19) and to decrease the exposure of … [Read more...] about FDA issues EUA allowing B. Braun infusion pumps to be used with nebulizers