Texas-based Pulmotect, which is developing an inhaled immune stimulant for the treatment of respiratory diseases, has announced the appointment of Colin Broom as CEO. Broom was most recently CEO of Nabriva Therapeutics and previously served as Chief Scientific Officer at ViroPharma and in various roles at Amgen, Aventis, and GSK. Pulmotect is a spin out of … [Read more...] about Pulmotect names Colin Broom as CEO
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AstraZeneca gets CRL for PT010
According to AstraZeneca, the FDA has issued a complete response letter to the company's NDA for PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of COPD. AstraZeneca recently announced positive results from the Phase 3 ETHOS trial of PT010 and said that the MDI had been approved in Japan as Breztri Aerosphere. Results from the ETHOS trial … [Read more...] about AstraZeneca gets CRL for PT010
Lannett makes deal for distribution of generic Advair in US
Lannett said that it has signed a US distribution agreement for rights to Respirent Pharmaceuticals' generic Advair Diskus. The agreement would begin after FDA approval and would continue for 10 years after distribution begins. Lannett said that it would pay an unspecified upfront payment and future milestones and that it would receive a portion of net profits during … [Read more...] about Lannett makes deal for distribution of generic Advair in US
Novartis reports positive results from Phase 3 study of QMF149 for asthma
Novartis has announced that its Phase 3 PALLADIUM trial of QMF149 indacaterol acetate/mometasone furoate (IND/MF) delivered via the Breezhaler DPI in patients with uncontrolled asthma met its primary endpoint, demonstrating superior improvement in lung function after 26 weeks compared to mometasone furoate alone. The company said that its MAA for QMF149 has been … [Read more...] about Novartis reports positive results from Phase 3 study of QMF149 for asthma
Nanoform announces evaluation of its technology by AstraZeneca
Particle engineering company Nanoform has announced that AstraZeneca is performing an evaluation of Nanoform's Controlled Expansion of Supercritical Solutions (CESS) technology "across a range of AstraZeneca’s proprietary pharmaceutical products." According to the Nanoform, its technology can produce particles as small as 10nm. Over the past few years, the … [Read more...] about Nanoform announces evaluation of its technology by AstraZeneca
Noveome initiates Phase 1 safety trial of intranasal biologic for delivery to the optic nerve
Noveome Biotherapeutics said that it has initiated a Phase 1 safety trial of its ST266 secretome delivered intranasally in patients with intraocular hypertension. The study will use a device from SipNose designed to deliver drugs across the blood-brain barrier to deliver ST266. Noveome is developing ST266 in several dosage forms, with intranasal ST266 also in … [Read more...] about Noveome initiates Phase 1 safety trial of intranasal biologic for delivery to the optic nerve
Currax Pharmaceuticals acquires North American rights to Onzetra Xsail
Currax Pharmaceuticals has acquired US, Canadian, and Mexican rights to Onzetra Xsail intranasal dry powder sumatriptan from OptiNose, which announced that the license agreement includes a $4.8 million upfront payment, plus a 10% royalty on net sales over $3 million in 2020 and a $1 million milestone payment "subject to the achievement of a specified regulatory … [Read more...] about Currax Pharmaceuticals acquires North American rights to Onzetra Xsail
Dance Biopharm changes its name to Aerami Therapeutics, moves headquarters, adds to pipeline
Dance Biopharm has announced a name change, saying that the company will now be known as Aerami Therapeutics. The company, which is developing the Dance 501 insulin SMI, said that it is also moving its headquarters from San Francisco, CA to Durham, NC, USA and is expanding its pipeline. The company recently presented results from the Phase 2 SAMBA 04 study of … [Read more...] about Dance Biopharm changes its name to Aerami Therapeutics, moves headquarters, adds to pipeline
Lachesis Biosciences gets grant for commercialization of nasal spray for dementia
The Australian government has awarded Victoria-based Lachesis Biosciences AUS$438,000 for commercialization of the company's rivastigmine nasal spray for the treatment of dementia in patients with Alzheimer's Disease. The Accelerating Commercialisation grant is designed to"help businesses turn good ideas into marketable products through activities such as trials, … [Read more...] about Lachesis Biosciences gets grant for commercialization of nasal spray for dementia
H&T Presspart officially opens new injection molding facility
Device maker H&T Presspart has officially opened a new injection molding facility known as "Fenix" in Tarragona, Spain, the company said. The plant manufactures MDI actuators and other delivery device components. H&T Presspart Tarragona Managing Directors Thomas Portune and Dana Shears attended the ribbon cutting ceremony along with the president of the … [Read more...] about H&T Presspart officially opens new injection molding facility