Canadian cannabinoid developer Tetra Bio-Pharma says that it has filed a patent application covering technology related to its PPP001 cannabis drug pellet. According to the company, the patent application covers fabrication methods and composition of matter. Tetra's announcement says, "research demonstrated that the class II medical device or pipe used to combust … [Read more...] about Tetra Bio-Pharma files patent application for inhaled cannabis drug
News
FDA approves Mylan’s generic version of Advair Diskus
The FDA announced that it has approved Mylan's generic version of Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma in patients four years old and older and for the treatment of COPD. Three strengths were approved: FP 100 μg/salmeterol 50 μg, FP 250 μg/salmeterol 50 μg and FP 500 μg/salmeterol 50 μg. In 2013, the FDA issued a draft … [Read more...] about FDA approves Mylan’s generic version of Advair Diskus
Aradigm announces submission of responses to EMA Day 120 questions
Aradigm Corporation, which submitted an MAA for its dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients in March 2018, has announced that it submitted responses to EMA Day 120 questions on January 23, 2019. The company said that it anticipates receiving a Day 180 list of … [Read more...] about Aradigm announces submission of responses to EMA Day 120 questions
Novus Therapeutics announces Phase 2a study of OP0201 intranasal MDI for otitis media
Novus Therapeutics has provided an update on ongoing Phase 1 clinical trials of its OP0201 nasal MDI for the treatment of otitis media and has announced plans for a Phase 2a study in infants and children. The new randomized, double-blind, placebo-controlled Phase 2a trial (C-006), which replaces a planned Phase 1 study in children with otitis media with effusion, … [Read more...] about Novus Therapeutics announces Phase 2a study of OP0201 intranasal MDI for otitis media
Nemera promotes Dimitri Grasswill to VP of Innovation
Device company Nemera has announced the promotion of the leader of its Innovation Center, Dimitri Grasswill, to VP of Innovation. Grasswill has directed the Innovation Center, located in La Verpillière, France, since 2013. In a tweet announcing his promotion, Grasswill is quoted as saying "I am proud of leading a passionate and creative team of drug delivery … [Read more...] about Nemera promotes Dimitri Grasswill to VP of Innovation
FDA approves Promius’s Tosymra sumatriptan nasal spray
The FDA has approved Promius Pharma's Tosymra sumatriptan nasal spray (formerly known as DFN-02) for the treatment of migraine, Promius parent company Dr. Reddy's has announced. The company submitted an NDA for the nasal spray in April 2018. Dr. Reddy's Laboratories Co-Chairman and CEO G.V. Prasad commented, “We are excited about the approval of Tosymra. This … [Read more...] about FDA approves Promius’s Tosymra sumatriptan nasal spray
Hovione announces that it has issued $50 million bond
CDMO Hovione has announced that it issued a $50 million bond, arranged and subscribed by Banco BPI, that is set to mature in 2033 in order to finance an expansion of its production capacity. The company has previously discussed recently completed and planned expansions of its manufacturing facilities in Portugal, Ireland, and the US, including the addition … [Read more...] about Hovione announces that it has issued $50 million bond
Circassia acquires US and Chinese rights to AIT’s AirNOvent inhaled nitric oxide
Circassia Pharmaceuticals will pay AIT Therapeutics $7.35 million up front plus potential milestone payments and royalties for the exclusive rights to commercialize AIT's AirNOvent ventilator compatible nitric oxide in the US and China, the company said. The company will issue ordinary shares to AIT to cover the upfront payment and anticipates doing the same for … [Read more...] about Circassia acquires US and Chinese rights to AIT’s AirNOvent inhaled nitric oxide
Ziccum submits patent application for dry powder adenovirus vaccine
Ziccum, a spin out from Inhalation Sciences, has announced that it submitted a patent application for a temperature-stable dry powder formulation of adenovirus. According to the company, the formulation, which would be suitable for delivery by inhalation, can be held at over 40 °C for more than a week with no degradation. In July 2018, Ziccum announced that it had … [Read more...] about Ziccum submits patent application for dry powder adenovirus vaccine
FDA publishes model DFL to encourage development of OTC naloxone nasal spray
FDA Commissioner Scott Gottlieb has issued a statement detailing steps that the agency is taking to encourage development of an over the counter naloxone nasal spray, including the publication of a model drug facts label (DFL). Gottlieb said, "I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with … [Read more...] about FDA publishes model DFL to encourage development of OTC naloxone nasal spray