Actavis has announced that it is relaunching 0.25 and 0.5 mg vials of budesonide inhalation suspension, a generic version of AstraZeneca's Pulmicort Respules, after the United States Court of Appeals for the Federal Circuit lifted an injunction preventing Actavis from marketing the product. The court upheld a lower court's determination that US Patent No. 7,524,834, … [Read more...] about Appeals court confirms Pulmicort Respules patent invalid, Actavis re-launches its generic version
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Egalet to begin promoting Sprix nasal spray
Pennsylvania-based Egalet Corporation has announced that it will begin promoting Sprix ketorolac tromethamine nasal spray in the second quarter of 2015. Sprix is a non-steroidal anti-inflammatory drug (NSAID) for the short-term treatment of moderate to moderately severe pain, which was acquired by Egalet from Daiichi Sankyo subsidiary Luitpold Pharmaceuticals earlier … [Read more...] about Egalet to begin promoting Sprix nasal spray
Timer Designs introduces new Compliance Cradle for Breo Ellipta
Timer Designs, a Dutch company specializing in compliance devices, has introduced a new version of its Compliance Cradle for Breo Ellipta, which GSK will supply with the inhaler, the company said. The cradle uses an optical system to monitor the presence of the inhaler and provides an audio alarm if the patient fails to remove the inhaler at the scheduled dosing … [Read more...] about Timer Designs introduces new Compliance Cradle for Breo Ellipta
Capsugel announces manufacture of clinical trial supplies of DPI formulation
Capsugel has announced that Bend Research, which Capsugel acquired in September 2013, has manufactured Phase 2 clinical trial supplies of a DPI formulation, its first inhalation product manufactured at that scale. The biopharmaceutical formulation was produced at the company's clinical trial manufacturing facility in Bend, Oregon. In late 2013, Bend Research announced … [Read more...] about Capsugel announces manufacture of clinical trial supplies of DPI formulation
AIT’s nitric oxide product for CF gets European orphan designation
Advanced Inhalation Therapies (AIT) has announced that its AIT-CF high dose inhaled formulation of nitric oxide (NO) for the treatment of cystic fibrosis has been granted orphan medical product designation by the European Commission. In February 2015, the company announced that the product had received orphan drug designation from the FDA in late 2014. AIT Chief … [Read more...] about AIT’s nitric oxide product for CF gets European orphan designation
FDA approves Breo Ellipta for the treatment of asthma in adults
The FDA has approved GSK's supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was approved by the FDA for the treatment of COPD in May 2013. In March 2015, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug … [Read more...] about FDA approves Breo Ellipta for the treatment of asthma in adults
Alexza Pharmaceuticals announces promotions
Inhaled drug developer Alexza Pharmaceuticals has announced the promotions of Edwin S. Kamemoto to Executive VP, R&D and Quality and Lori H. Takahashi to VP, Pharmaceutical R&D and Quality. Both positions are newly created. Kamemoto joined Alexza in 2006 and was most recently Senior VP, Regulatory Affairs. Takahashi joined Alexza in 2005 and most recently served as … [Read more...] about Alexza Pharmaceuticals announces promotions
InCarda raises more than $5 million for development of inhaled cardiac drugs
California-based InCarda Therapeutics (formerly Pleiades Cardio-Therapeutics) has announced that it raised over $5 million with the possibility of an additional $1.5 million in a private financing round led by Morningside Venture. According to the company, it will use the proceeds for development of an inhaled therapy for paroxysmal atrial fibrillation. InCarda … [Read more...] about InCarda raises more than $5 million for development of inhaled cardiac drugs
Inhalation Sciences announces new name of PreciseInhale 3D module
Inhalation Sciences AB (ISAB) has announced that the 3D module of its PreciseInhale dry powder aerosol testing system is now called "XposeALI." Using air liquid interface (ALI) technology, ISAB creates 3D models with primary epithelial cells that allow for completion of a PK study using 50 – 100 mg of the test material, the company said. ISAB CEO Fredrik Sjövall … [Read more...] about Inhalation Sciences announces new name of PreciseInhale 3D module
New ASTM standard for Freeman Technology powder rheometer
ASTM International's Subcommittee on Characterization and Handling of Powders and Bulk Solids has published a new standard titled "Standard Test Method for Shear Testing of Powders using the Freeman Technology FT4 Powder Rheometer Shear Cell." The Freeman Technology FT4 instrument is used for characterization of powders, including the optimization of dry powder … [Read more...] about New ASTM standard for Freeman Technology powder rheometer