The batch of new product specific guidances published by the FDA in November 2020 include guidances for generic OINDPs referencing Valtoco diazepam nasal spray, Primatene Mist epinephrine MDI, and Spiriva Respimat tiotropium bromide SMI. The agency approved Valtoco for the treatment of seizure clusters in January 2020. After a lengthy effort to reformulate … [Read more...] about FDA issues new product specific guidances for diazepam nasal spray, epinephrine MDI, and tiotropium bromide SMI
News
US Court of Appeals upholds judgment against GSK for infringing on Vectura patents
According to inhalation CDMO Vectura, the United States Court of Appeals for the Federal Circuit has upheld a ruling by the District Court of Delaware against GlaxoSmithKline for infringing on a Vectura patent and has denied GSK a new trial. If GSK wants to ask to have the case heard again, it has 30 days to file a petition. In May 2019, a jury found that GSK … [Read more...] about US Court of Appeals upholds judgment against GSK for infringing on Vectura patents
Zeteo Biomedical to provide nasal delivery technology for Iowa State University vaccine against SARS-CoV-2
Zeteo Biomedical said that the company will supply its ZEOx2 nasal delivery system and unit dose packaging for use with a shelf-stable SARS-CoV-2 vaccine in development at the Nanovaccine Institute at Iowa State University. Zeteo is already working with Iowa State on an intranasal universal flu vaccine. The ZEOx2 platform can be used for intranasal delivery of dry … [Read more...] about Zeteo Biomedical to provide nasal delivery technology for Iowa State University vaccine against SARS-CoV-2
Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT
Milestone Pharmaceuticals has announced the initiation of the RAPID Phase 3 trial of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). A previous Phase 3 trial, NODE-301, failed to meet its primary endpoint. In July 2020, Milestone announced that it had reached an agreement with the FDA on the design of the RAPID study … [Read more...] about Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT
DDL 2020 to offer virtual meeting for free
The Drug Delivery to the Lungs (DDL) meeting was due to return to the Edinburgh International Conference Centre December 9-11 this year following the celebration of its 30th anniversary and it's 15th year bringing hundreds of OINDP experts to Edinburgh, UK in 2019; but due to the COVID-19 epidemic, it will be at least 2021 before the meeting returns to Scotland. A … [Read more...] about DDL 2020 to offer virtual meeting for free
Revelation Biosciences initiates Phase 1 trial of REVTx-99 intranasal PHAD
Revelation Biosciences, which announced in October 2020 that the TGA had approved plans for a Phase 1 study of its REVTx‑99 intranasal phosphorylated hexaacylated disaccharide (PHAD), said that it has now initiated the trial. According to the company, 8 healthy volunteers have already received either REVTx-99 or placebo in the single ascending dose study, which is … [Read more...] about Revelation Biosciences initiates Phase 1 trial of REVTx-99 intranasal PHAD
Kindeva Drug Delivery begins construction of new headquarters
CDMO Kindeva Drug Delivery announced that it has broken ground on a new 137,500 sq ft headquarters building in Woodbury, MN, USA; the company anticipates that the building will be opened in the latter half of 2021. Kindeva, formerly 3M Drug Delivery Systems, offers a wide range of services to support OINDP development and manufacturing, ranging from formulation to … [Read more...] about Kindeva Drug Delivery begins construction of new headquarters
BlueWillow and Medigen partner on development of intranasal vaccine to prevent COVID-19
Medigen Vaccine Biologics and BlueWillow Biologics have partnered for development of S-2P-NE-01, an intranasal vaccine against the SARS-CoV-2 virus, the companies said. According to the announcement, the vaccine will include BlueWillow's NanoVax nasal vaccine adjuvant and Medigen's S-2P spike protein; preclinical studies in mice have shown that the combination … [Read more...] about BlueWillow and Medigen partner on development of intranasal vaccine to prevent COVID-19
TFF and Felix Biotechnology sign letter of intent for proposed development of inhaled bacteriophage for the treatment of lung infections
TFF Pharmaceuticals and Felix Biotechnology have signed a non-binding letter of intent for a proposed agreement regarding development of an inhaled dry powder bacteriophage for the treatment of lung infections. Felix would need to successfully complete a Series A financing before entering into a definitive agreement, which would provide for Felix to make an upfront … [Read more...] about TFF and Felix Biotechnology sign letter of intent for proposed development of inhaled bacteriophage for the treatment of lung infections
Altimmune signs deal with Lonza for AdCOVID manufacturing
Altimmune has signed a manufacturing agreement with Lonza for its AdCOVID intranasal vaccine candidate for the prevention of COVID-19, the companies said. In March 2020, Altimmune announced that it had partnered with the University of Alabama Birmingham for development of AdCOVID; the company subsequently announced an agreement with DynPort Vaccine Company for funding … [Read more...] about Altimmune signs deal with Lonza for AdCOVID manufacturing