News
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The FDA has approved Teva’s supplemental NDA for ProAir RespiClick albuterol breath-activated DPI for the treatment or asthma in children aged 4 to 11, the company has announced. The sNDA filing was accepted by the… Read more . . .
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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules — both New Chemical Entities (NCE’s) and New Biological Entities (NBEs’), with eight molecules in… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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,… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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3M Drug Delivery Systems has announced the launch of the 3M Intelligent Control Inhaler, a connected, breath-actuated inhaler that provides instructions to the patient via a screen integrated into the device and provides feedback to… Read more . . .
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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… Read more . . .
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