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Nanopharm announces launch of dissolution testing for inhaled drugs using its UniDose collection system

OINDP analysis and development specialist Nanopharm is now offering dissolution testing services using its proprietary UniDose aerosol collection apparatus, the company said. UniDose allows analysts to conduct dissolution testing that is independent of the collected dose. The system deposits the entire dose at a low impaction velocity onto a high surface area … [Read more...] about Nanopharm announces launch of dissolution testing for inhaled drugs using its UniDose collection system

Phase 3 trials of Sunovion’s nebulized glycopyrrolate meet primary endpoints

Sunovion has announced that the GOLDEN-3 and GOLDEN-4 Phase 3 clinical trials of SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD both met their primary endpoints. SUN-101, delivered via the PARI eFlow handheld nebulizer, demonstrated statistically significant improvement in FEV1 versus placebo after 12 weeks for both the 50 … [Read more...] about Phase 3 trials of Sunovion’s nebulized glycopyrrolate meet primary endpoints

Aradigm announces private placement of $23 million to fund continued Pulmaquin development

Aradigm Corporation has announced the first closing of a private placement of $23 million in senior convertible notes that mature in 2021 and warrants to purchase 263,436 shares of common stock at $5.21 per share, "beginning on the later of 180 days after the date of issuance or the date the company issues a press release announcing data related to the ORBIT-3 and … [Read more...] about Aradigm announces private placement of $23 million to fund continued Pulmaquin development

AstraZeneca’s Bevespi Aerosphere MDI approved by the FDA

The FDA has approved AstraZeneca's Bevespi Aerosphere glycopyrrolate/formoterol fumarate MDI (formerly PT003) for the treatment of COPD, the company has announced. The product is AstraZeneca's first to use the Co-Suspension technology patented by Pearl Therapeutics in 2012. AstraZeneca acquired Pearl in 2013. Data from the Phase 3 PINNACLE trial, which was … [Read more...] about AstraZeneca’s Bevespi Aerosphere MDI approved by the FDA

FDA issues product-specific draft guidances for four more inhalation products

The US FDA has issued four new product-specific draft guidances in April 2016 for inhalation products, including three dry powder products and one MDI. The documents include recommendations on establishing bioequivalence for generic versions of Breo/Relvar Ellipta, Arnuity Ellipta, Arcapta Neohaler/Onbreez Breezhaler, and Asmanex HFA, Read the new guidances for … [Read more...] about FDA issues product-specific draft guidances for four more inhalation products

Aytu acquires US rights to Acerus’s Natesto nasal testosterone

Aytu BioScience has acquired US rights to Natesto testosterone nasal gel from Acerus (formerly Trimel) for $8 million up front, including $2 million on signing and an additional $6 million by the end of FY 2017, the companies have announced. Under the deal, which extends through at least February 2024, Aytu will pay milestones of up to $37.5 million. Aytu will also … [Read more...] about Aytu acquires US rights to Acerus’s Natesto nasal testosterone

Mystic Pharmaceuticals gets patent for nose to brain delivery systems for CNS drugs

The United States Patent and Trademark Office has issued US Patent 9,248,076 B2, titled “Dose Dispensing Containers,” to Mystic Pharmaceuticals, the company has announced. The patent covers nose-to-brain delivery systems for therapies to treat brain disorders such as Alzheimer’s disease and traumatic brain injury using Mystic's VersiDoser and VRx2 blister packaging … [Read more...] about Mystic Pharmaceuticals gets patent for nose to brain delivery systems for CNS drugs