According to US-based ARS Pharmaceuticals, the company has raised $20 million in Series C financing for clinical development of its ARS-1 epinephrine nasal spray for the treatment of anaphylaxis. The financing round was led by Deerfield Management. ARS said that it has submitted an IND for the intranasal epinephrine, which incorporates Aegis Therapeutics' Intravail … [Read more...] about ARS Pharmaceuticals raises $20 million for clinical development of epinephrine nasal spray
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AOBiome Therapeutics names Judith Ng Cashin as Chief Medical Officer
AOBiome Therapeutics, which is developing several intranasal ammonia oxidizing bacteria (AOB) candidates, said that Judith Ng-Cashin was appointed Chief Medical Officer as of October 1, 2018. Ng-Cashin was most recently Chief Scientific Officer at Syneos Health. She has also held a variety of executive positions at IQVIA (formerly Quintiles) and GSK. In April … [Read more...] about AOBiome Therapeutics names Judith Ng Cashin as Chief Medical Officer
Muscosal delivery technology startup MyX Therapeutics launches with $450,000 seed investment
Canadian life science fund AmorChem has announced the launch of MyX Therapeutics, which will focus on development of drugs formulated with MyX-001 mucoadhesive nanoparticle delivery platform, with a $450,000 seed investment. MyX-001 is based on technology developed by Frank Gu, Lyndon Jones, and Sandy Liu of the University of Waterloo. Gregory L. White will serve … [Read more...] about Muscosal delivery technology startup MyX Therapeutics launches with $450,000 seed investment
Verona initiates Phase 2 trial of RPL554 DPI for COPD
Verona Pharma said that it has initiated a Phase 2 clinical trial of its RPL554 PDE3/PDE4 inhibitor DPI. The study is expected to enroll 36 patients with moderate to severe COPD and will evaluate PK, efficacy, and safety. Verona is developing RPL554 as nebulized, DPI, and MDI formulations for various indications, including COPD, asthma, and cystic fibrosis. … [Read more...] about Verona initiates Phase 2 trial of RPL554 DPI for COPD
Insys says it plans NDA submissions for two nasal sprays in 2019
Insys Therapeutics says that it plans NDA submissions for both its naloxone and epinephrine nasal sprays in 2019. The company also noted the potential of regulatory submission for its inhaled dronabinol in the next few years. According to Insys, a PK study of the naloxone nasal spray "showed a distinctive profile for the . . . nasal spray product candidate in … [Read more...] about Insys says it plans NDA submissions for two nasal sprays in 2019
Pharmaxis relaunches Aridol in the US
Pharmaxis said that its distribution partner Methapharm Inc. has begun selling Pharmaxis' Aridol mannitol bronchial challenge test kit again in the United States. According to the company, its Sydney, Australia manufacturing facility received FDA approval to manufacture Aridol for the US market in August 2018. Aridol is also approved in Australia, South Korea, and … [Read more...] about Pharmaxis relaunches Aridol in the US
Nanoform announces construction of new GMP manufacturing facility
Finnish nanotechnology company Nanoform has announced construction of a new 600m2 GMP manufacturing facility at Viikki Life Science Park in Helsinki. The plant, which is expected to be operational sometime in 2019, will result in a six-fold increase the company's capacity for nanonization of API for clinical trial use and will add the capability to handle potent APIs. … [Read more...] about Nanoform announces construction of new GMP manufacturing facility
Levo Therapeutics initiates Phase 3 study of intranasal carbetocin for Prader-Willi Syndrome
According to Levo Therapeutics, the Phase 3 CARE-PWS (CARbetocin Efficacy and Safety Study in PWS) trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) has begun to enroll patients. Levo acquired the rights to the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and announced in June 2018 that it planned to restart the … [Read more...] about Levo Therapeutics initiates Phase 3 study of intranasal carbetocin for Prader-Willi Syndrome
Biocorp and Lindal partner to commercialize Inspair inhaler sensor in several regions
French device company Biocorp announced that it has signed an agreement with Lindal Group subsidiary VARI under which VARI will incorporate Biocorp's Inspair inhaler sensor into its devices in a deal that includes exclusivity for countries in South America, Southeast Asia, Eastern Europe, and the Middle East. Biocorp announced the launch of the Inspair sensor in … [Read more...] about Biocorp and Lindal partner to commercialize Inspair inhaler sensor in several regions
Iconovo gets order from TOA Pharmaceuticals for devices to be used in feasibility study
According to Iconovo, Japanese pharmaceutical company TOA Pharmaceuticals has placed a "significant" order for DPIs to be used in a feasibility study. Iconovo will produce two customized versions of the inhaler and will conduct the feasibility study with four different commercially available dry powder products to determine how those products perform in the Iconovo … [Read more...] about Iconovo gets order from TOA Pharmaceuticals for devices to be used in feasibility study