Cipla said that it has received final approval for an ANDA for its generic version of Bausch's Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company's first FDA approval for a generic nasal spray; the agency has recently approved an ANDA for Cipla's generic Proventil HFA. The FDA approved the … [Read more...] about FDA approves Cipla’s generic of Migranal DHE nasal spray with CGT designation
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Bevespi Aerosphere approved in China for the treatment of COPD
The Chinese National Medical Products Administration (NMPA) has approved AstraZeneca's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. AstraZeneca's Breztri Aerosphere budesonide/glycopyrronium/formoterol fumarate MDI was approved for the treatment of COPD by the NMPA in December 2019. In June 2019, Bevespi … [Read more...] about Bevespi Aerosphere approved in China for the treatment of COPD
Covis announces initiation of Phase 3 US trial of Alvesco ciclesonide MDI for the treatment of COVID-19
Covis Pharma said that it has initiated a Phase 3 of Alvesco ciclesonide MDI for the treatment of COVID-19 in US patients aged 12 and older who have not been hospitalized, with preliminary results expected in late-August/early-September 2020. According to Covis, studies of Alvesco for COVID-19 are already underway in Australia, Japan, South Korea, Sweden, and the … [Read more...] about Covis announces initiation of Phase 3 US trial of Alvesco ciclesonide MDI for the treatment of COVID-19
Teva Canada imports supply of UK-branded salbutamol (albuterol) MDIs under interim order
Teva Canada said that it has imported a 4-week supply of Salamol salbutamol (albuterol) sulfate MDIs through Teva UK under an interim order by the Minister of Health in response to shortages of the inhalers in Canada caused by the COVID-19 pandemic. Salamol MDIs are marketed by IVAX Pharmaceuticals in the UK; Teva acquired IVAX in 2006. Health Canada recently … [Read more...] about Teva Canada imports supply of UK-branded salbutamol (albuterol) MDIs under interim order
Cipla submits ANDA for generic version of Advair Diskus
Cipla has submitted an ANDA for a generic version of GSK's Advair Diskus fluticasone propionate/salmeterol DPI in 100/50 mcg, 250/50 mcg and 500/50 dosage strengths for the treatment of asthma and COPD, the company said. In April 2020, Cipla announced results from a Phase 3 trial demonstrating therapeutic equivalence for the 100/50 mcg dose. Cipla Limited Global … [Read more...] about Cipla submits ANDA for generic version of Advair Diskus
Tushar Shah joins Liquidia Technologies as Chief Medical Officer
Liquidia Technologies has announced the appointment of former Teva Pharmaceuticals Global Head of Specialty Clinical Development Tushar Shah as the company's first Chief Medical Officer. Prior to his most recent position, Shah had served as Senior VP, Global Respiratory Research and Development at Teva. His career in pharmaceutical research has also included positions … [Read more...] about Tushar Shah joins Liquidia Technologies as Chief Medical Officer
DDL 2020 cancelled; organizers plan series of virtual “DDL Christmas Lectures”
The organizing committee for DDL 2020, which was scheduled for December 9-11 in Edinburgh, UK, has announced the cancellation of the meeting, saying, "In addition to showcasing great new science, a major part of the success of the annual DDL meeting is the networking and festive feel-good atmosphere experienced by the attendees meeting together in Edinburgh. In light … [Read more...] about DDL 2020 cancelled; organizers plan series of virtual “DDL Christmas Lectures”
VistaGen proposes Phase 2a study of PH94B nasal spray for the treatment of anxiety related to the COVID-19 pandemic
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
Digital RDD 2020 in review
Digital RDD 2020 opened on April 26 at 3 p.m. Pacific Standard Time -- exactly when the meeting would have opened had it been held in California. After being forced to cancel the California meeting due to the COVID-19 epidemic, the meeting organizers, presenters, and exhibitors scrambled to come up with a digital version of the conference on short notice. Most of … [Read more...] about Digital RDD 2020 in review
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