Evoke Pharma said that it has signed a deal with Novos Growth Partners (NGP) for commercialization of its Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women. Evoke's NDA for Gimoti was submitted in June 2018, and the FDA set a PDUFA date of April 1, 2019 for completion of its review. According to Evoke, … [Read more...] about Evoke Pharma partners with Novus Growth Partners for commercialization of Gimoti nasal spray
Business
Senzer’s SiDD inhaler wins Good Design Award
Senzer has announced that its breath-activated Systemic inhaled Delivery Device (SiDD) inhaler has won a 2018 Good Design award in the medical category. The Good Design Awards are presented by The Chicago Athenaeum: Museum of Architecture and Design "for the most innovative and cutting-edge industrial, product, and graphiτc designs produced around the world." In … [Read more...] about Senzer’s SiDD inhaler wins Good Design Award
Stem Cell Medicine licenses intranasal MSC-exo technology for the treatment of autism
Biotech company Stem Cell Medicine (SCM) has announced that it licensed intranasal MSC-exo technology for the treatment of autism spectrum disorder (ASD) from Ramot, the Tel Aviv University Business Engagement Center. Preclinical studies have shown that intranasally delivered MSC-exo demonstrated significant improvement in autistic behaviors in a mouse … [Read more...] about Stem Cell Medicine licenses intranasal MSC-exo technology for the treatment of autism
Syqe Medical raises $50 million for inhaler development
According to a report in Israeli financial newspaper Globes, Tel Aviv-based Syqe Medical has raised $50 million in a financing round led by Shavit Capital for continued development of its medicinal plants inhaler. Shavit Capital has posted the news report on its website. The Syqe inhaler delivers metered doses using heat and a controlled flow of air through … [Read more...] about Syqe Medical raises $50 million for inhaler development
ARS Pharmaceuticals raises $20 million for clinical development of epinephrine nasal spray
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
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
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
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
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
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