December 2016
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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Senzer Pharmaceuticals said that it plans to launch its cannabinoid inhaler in the UK and elsewhere in Europe by the end of 2019 now that the device has received Class IIa Medical Device approval for the… Read more . . .
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