The Monash University Institute of Pharmaceutical Sciences (MIPS) has announced positive results from a Phase 1 study of inhaled oxytocin in healthy volunteers. The study was conducted by GSK, which is partnered with Monash University to develop inhaled oxytocin for the treatment of postpartum hemorrhage. According to MIPS, the PK data presented at the Royal … [Read more...] about Positive results for Phase 1 study of inhaled oxytocin
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PARI Pharma licences inhaled therapy for bronchiolitis obliterans syndrome to Breath Therapeutics
According to PARI Pharma, the company has licensed a formulation of liposomal cyclosporine A for the treatment of bronchiolitis obliterans syndrome (BOS) to Breath Therapeutics. Breath Therapeutics, a spin off of PARI, recently announced that it has raised €43.5 million in Series A Financing, which it will use for Phase 3 trials of the product, regulatory … [Read more...] about PARI Pharma licences inhaled therapy for bronchiolitis obliterans syndrome to Breath Therapeutics
Circassia acquires rights to Tudorza and Duaklir DPIs in the US
AstraZeneca has announced an agreement with Circassia Pharmaceuticals for development and commercialization of the Tudorza and Duaklir dry powder inhalers in the US. AstraZeneca will receive $50 million in Circassia ordinary shares and $100 million on approval of Duaklir in the US or June 30, 2019, whichever comes first. Circassia will have the option to acquire … [Read more...] about Circassia acquires rights to Tudorza and Duaklir DPIs in the US
Cohero Health raises an additional $1.5 million in Series A
Connected health company Cohero Health has added $1.5 million from new investors Samsung NEXT and Omron Healthcare to its Series A round, the company said. In November 2016, Cohero announced closure of the $9 million round but later decided to allow the additional investments. One of the initial investors was Heitkamp & Thumann Group, parent company of H&T … [Read more...] about Cohero Health raises an additional $1.5 million in Series A
MedInvent to market NasoNeb II nasal nebulizer in Europe
US-based MedInvent has obtained CE Marking and ISO 13485 and CMDCAS certification for its NasoNeb II nasal nebulizer, the company said. The company has also signed a distribution contract with Vedise Hospital in Rome, Italy, which will market the product in Italy, San Marino, and Vatican City. MedInvent says that it plans to market the nasal nebulizer throughout … [Read more...] about MedInvent to market NasoNeb II nasal nebulizer in Europe
MVIC announces new CEO, new member company, new services
The Medicon Valley Inhalation Consortium (MVIC) has announced that Lars Asking, who has served as VP of MVIC since May 2016, will become CEO of the consortium as of May 2017. Asking will take over the role from Ola Nerbrink who will continue as VP Business Development. Nerbrink succeeded Orest Lastow as CEO of MVIC in 2014. In addition, MVIC said that AB I Lamberg … [Read more...] about MVIC announces new CEO, new member company, new services
FDA warns Wockhardt subsidiary over fluticasone propionate nasal spray manufacturing and testing violations
A February 17, 2017 FDA warning letter to Wockhardt subsidiary Morton Grove Pharmaceuticals cites numerous cGMP violations, including several related to the manufacture of fluticasone propionate nasal spray. Wockhardt's generic fluticasone propionate nasal spray was approved by the FDA in January 2012. The letter states that "During our inspection, we observed … [Read more...] about FDA warns Wockhardt subsidiary over fluticasone propionate nasal spray manufacturing and testing violations
Milestone Pharmaceuticals appoints Joseph G. Oliveto as President and CEO
Milestone Pharmaceuticals has announced the appointment of Joseph G. Oliveto as President and CEO. Oliveto, who was most recently CEO of Galleon Pharmaceuticals and previously served as President and CEO of Chelsea Therapeutics, is replacing company founder Phillippe Douville, who is now Chief Scientific Officer. Milestone's lead candidate, etripamil is an … [Read more...] about Milestone Pharmaceuticals appoints Joseph G. Oliveto as President and CEO
Mast Therapeutics announces Phase 1/2 study of AIR001 for the treatment of P. aeruginosa infections in CF patients
According to Mast Therapeutics, the University of Pittsburgh will conduct a Phase 1/2 open-label safety and proof of concept clinical trial of AIR001 sodium nitrite inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. Mast subsidiary Aires Pharmaceuticals will get rights to the data but is providing no support other than … [Read more...] about Mast Therapeutics announces Phase 1/2 study of AIR001 for the treatment of P. aeruginosa infections in CF patients
FDA approves Noctiva desmopressin nasal spray for the treatment of nocturnal polyuria
The FDA has announced the approval of Noctiva desmopressin acetate nasal spray for the treatment of nocturnal polyuria (overproduction of urine at night). Allergan licensed SER120 desmopressin nasal spray from Serenity Pharmaceuticals in 2010. In 2007, the FDA announced that intranasal desmopressin was no longer indicated for the treatment of nocturnal enuresis … [Read more...] about FDA approves Noctiva desmopressin nasal spray for the treatment of nocturnal polyuria