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News

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

Circassia to exercise option to acquire full US rights to Tudorza aclidinium DPI

Circassia Pharmaceuticals notified AstraZeneca that it will exercise its option to acquire the full US commercial rights to the Tudorza aclidinium DPI, the company said. Circassia acquired US rights to Tudorza and to Duaklir aclidinium/formoterol DPI in March 2017 in a deal that included 50/50 profit sharing with AstraZeneca. Completion of the option exercise, … [Read more...] about Circassia to exercise option to acquire full US rights to Tudorza aclidinium DPI

Acerus announces results from Phase 1 study of intranasal cannabis oil formulation

Acerus Pharmaceuticals said that a Phase 1 trial of its intranasal formulation of tetrahydrocannabinol-rich cannabis oil in 12 healthy volunteers demonstrated that the bioavailability of TCH from the nasal formulation was 2.2 times better than previously reported bioavailability data for oral dronabinol. Average Tmax was found to be 7 hours after administration. … [Read more...] about Acerus announces results from Phase 1 study of intranasal cannabis oil formulation

Avanir to terminate license agreement for Onzetra Xsail intranasal sumatriptan

Avanir and Optinose have separately announced the termination of the license agreement that gave Avanir the North American rights to develop and commercialize Onzetra Xsail intranasal sumatriptan. The license agreement, which was initially announced in 2013, is expected to terminate on March 10, 2019. Onzetra Xsail was approved by the FDA in January 2016, and … [Read more...] about Avanir to terminate license agreement for Onzetra Xsail intranasal sumatriptan

Zambon’s inhaled colistimethate sodium gets QIDP and fast track designations

Zambon has announced that its colistimethate sodium powder for nebulized delivery as a solution by the Philips i-neb nebulizer system, has received QIDP and fast track designations from the FDA for the prevention of exacerbations in non-cystic fibrosis bronchiectasis patients with P. aeruginosa lung infections. The company said that two Phase 3 studies of … [Read more...] about Zambon’s inhaled colistimethate sodium gets QIDP and fast track designations

Copley Scientific introduces new mixing inlet and a firmware update for the TPK 2100 Critical Flow Controller

Copley Scientific has announced the launch of a 316 stainless steel mixing inlet for use in aerodynamic particle size distribution (APSD) measurement, available in versions for both ACI and NGI impactors. The company also announced the availability of a firmware update for its TPK 2100 Critical Flow Controller that provides greater logging and recording … [Read more...] about Copley Scientific introduces new mixing inlet and a firmware update for the TPK 2100 Critical Flow Controller

Auris Medical’s intranasal betahistine gets orphan drug designation, expanded development

According to Auris Medical, the FDA has granted orphan drug designation to its intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS). The company also said that it has signed a letter of intent to in-license rights to US patents covering the use of betahistine for two other indications, depression and … [Read more...] about Auris Medical’s intranasal betahistine gets orphan drug designation, expanded development

Impel Neuropharma raises over $67 million for development of intranasal products

Intranasal drug developer Impel NeuroPharma has raised $67.5 million in a Series D financing round led by KKR and Norwest Venture Partners, the company said. Existing investors Vivo Capital, 5AM Ventures and venBio Partners also participated. According to Impel, the funds will be used to accelerate development of its pipeline of drugs based on its Precision Olfactory … [Read more...] about Impel Neuropharma raises over $67 million for development of intranasal products

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