Funds managed by Oaktree Capital Management will provide $100 million in funding to Impel NeuroPharma, with $50 million of that amount in cash up front as part of a royalty agreement on net sales of Trudhesa dihydroergotamine (DHE) nasal spray and the other $50 million in the form of a credit facility. The FDA approved Trudhesa for the treatment of migraine in … [Read more...] about Impel Neuropharma secures $100 million for continued commercialization of Trudhesa nasal spray
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Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company's application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired the Chinese rights to OC-01 and OC-02 simpinicline nasal spray for the treatment of dry eye disease from Oyster Point Pharma in August 2021. In the … [Read more...] about Ji Xing gets go-ahead for Phase 3 trial of OC-01 varenicline nasal spray for dry eye disease in China
Consortium partners with RocketVax on intranasal COVID-19 vaccine development
A Swiss-German consortium led by Volker Thiel of the Institute of Virology and Immunology and the University of Bern has partnered with Swiss startup RocketVax to develop two live attenuated intranasal vaccine candidates against SARS-CoV-2 for planned Phase 1 trials. The consortium, which also includes researchers from the University of Geneva, the Freie Universität … [Read more...] about Consortium partners with RocketVax on intranasal COVID-19 vaccine development
Positive Phase 1b results for Pulmatrix’s PUR1800 inhaled narrow spectrum kinase inhibitor
Pulmatrix has announced that topline data from a Phase 1b study of its PUR1800 dry powder narrow spectrum kinase inhibitor in COPD patients showed that inhaled PUR1800 produced "low and consistent systemic exposure" with "no observed safety signals" In January 2020, when Pulmatrix announced a license agreement with the Lung Cancer Initiative at Johnson & Johnson … [Read more...] about Positive Phase 1b results for Pulmatrix’s PUR1800 inhaled narrow spectrum kinase inhibitor
FDA approves Rx-to-OTC switch for Perrigo’s Nasonex 24HR Allergy nasal spray
According to Perrigo, the FDA has approved its NDA for Nasonex 24HR Allergy mometasone furoate nasal spray for the treatment of allergy symptoms, the first branded Rx-to-OTC switch for Perrigo, and the company expects to launch Nasonex 24HR Allergy sometime in 2022. In 2018, the company announced that it had acquired US rights to an OTC version of Nasonex from Merck. … [Read more...] about FDA approves Rx-to-OTC switch for Perrigo’s Nasonex 24HR Allergy nasal spray
OINDP experts will once again meet in person at RDD 2022
RDD 2022 (May 1-5 in Orlando, Florida) will be the first major OINDP meeting to take place primarily in person since the beginning of the COVID-19 pandemic. According to Richard Dalby of RDD Online, organizers of the Respiratory Drug Delivery conferences, attendees at RDD 2022 in Orlando will find all of the features of RDD meetings they are accustomed to, including … [Read more...] about OINDP experts will once again meet in person at RDD 2022
TFF partners with US army on intranasal dry powder vaccine against SARS-CoV-2
TFF Pharmaceuticals said that the company has entered into an additional Cooperative Research and Development Agreement (CRADA) with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Geneva Foundation for formulation of an intranasal dry powder recombinant vesicular stomatitis virus (rVSV) against SARS-CoV-2 using … [Read more...] about TFF partners with US army on intranasal dry powder vaccine against SARS-CoV-2
FDA approves Mylan (Viatris) generic of Symbicort MDI (updated)
The FDA has approved a generic version of AstraZeneca's Symbicort budesonide / formoterol fumarate MDI from Mylan (now Viatris), the agency announced. The FDA tentatively approved the Mylan ANDA in March 2021 just after a court had ruled in favor of AstraZeneca in its suit against Mylan and Kindeva Drug Delivery (formerly 3M Drug Delivery). In December 2021, an … [Read more...] about FDA approves Mylan (Viatris) generic of Symbicort MDI (updated)
Sandoz acquires inhaler developer Coalesce Product Development
Declaring that it is "determined to grow its portfolio in the complex generics space," Novartis generics division Sandoz announced its acquisition of device device developer Coalesce Product Development. Coalesce's inhaler technology include MDI, breath-actuated MDI, and DPI platforms. Sandoz said that it "sees respiratory as a key pillar of its ambitious long-term … [Read more...] about Sandoz acquires inhaler developer Coalesce Product Development
University of Liverpool partners with Aerogen on development of inhaled antimicrobials
Researchers from the University of Liverpool have partnered with nebulizer maker Aerogen on a project called "Treatment of Respiratory Infections with inhaled AntimicrobiaLs" (TRIAL), which will develop inhaled therapies for the treatment of bacterial and viral pulmonary infections in hospitalized patients. Funding for the £1.3million project comes from the … [Read more...] about University of Liverpool partners with Aerogen on development of inhaled antimicrobials