Hovione, which offers a wide range of inhalation drug development and manufacturing services, has announced that it will add 30,600 sq ft and a new commercial spray dryer to its East Windsor, NJ facility. The expansion will more than double the plant's size and capacity, and the company said that it expects to hire approximately 60 new employees to support the … [Read more...] about Hovione to more than double size, capacity of New Jersey facility
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BI announces new data from Stiolto/Spiolto Respimat studies
Boehringer Ingelheim has announced new data from the ENERGITO and OTEMTO studies of the Stiolto tiotropium/olodaterol Respimat inhaler for the treatment of COPD. The FDA approved Stiolto Respimat in May 2015; in Europe, where the product is known as Spiolto Respimat, BI announced approval by several countries in July 2015. BI previously announced data from OTEMTO … [Read more...] about BI announces new data from Stiolto/Spiolto Respimat studies
Teva acquires Gecko Health Innovations
Teva Pharmaceutical has acquired privately held Gecko Health Innovations and its CareTRx asthma and COPD management system. CareTRx works with a monitoring device called GeckoCap that attaches to an MDI plus a mobile phone app. The acquisition comes two months after AstraZeneca announced a partnership with inhaler monitoring company Adherium. Gecko Founder and CEO … [Read more...] about Teva acquires Gecko Health Innovations
Additional positive Phase 3 results for OptiNose intranasal fluticasone
OptiNose has announced positive results from the NAVIGATE I Phase 3 trial of its OPN-375 intranasal fluticasone for the treatment of nasal polyposis demonstrating statistically significant reduction of symptoms and total polyp grade. In June 2015, the company announced positive results from the NAVIGATE II trial. Based on the results from both studies, OptiNose said, … [Read more...] about Additional positive Phase 3 results for OptiNose intranasal fluticasone
Alexza considers “strategic options to enhance stockholder value”
Inhaled drug developer Alexza Pharmaceuticals has hired a financial advisor "to assist in exploring strategic options to enhance stockholder value," the company said. Options being explored include selling corporate assets, a strategic business combination, or a partnership. Earlier this year, Alexza announced that it would suspend manufacturing of Adasuve inhaled … [Read more...] about Alexza considers “strategic options to enhance stockholder value”
Insys to develop inhaled cannabinoids using Voke inhaler technology, hires OINDP specialists
Insys Therapeutics has announced that it will partner with Senzer Ltd, a subsidiary of Kind Consumer, to develop inhaled dronabinol (THC) and cannabidiol (CBD) products. Insys has licensed Senzer's delivery technology, the same technology in the Voke nicotine inhaler, which was approved in the UK in September 2014. Senzer CEO and Kind Consumer founder Alex Hearn … [Read more...] about Insys to develop inhaled cannabinoids using Voke inhaler technology, hires OINDP specialists
FDA grants priority review to Adapt Pharma’s NDA for Narcan naloxone nasal spray
Adapt Pharma announced that the FDA has accepted its filing and granted priority review to its New Drug Application for Narcan naloxone hydrochloride nasal spray for the treatment of opioid overdose. Adapt submitted the NDA in July 2015. Lightlake Therapeutics licensed the nasal spray to Adapt in December 2014, and the FDA granted Fast Track designation for the … [Read more...] about FDA grants priority review to Adapt Pharma’s NDA for Narcan naloxone nasal spray
GSK and Theravance announce planned submission of Japanese sNDA for Relvar Ellipta
GlaxoSmithKline and Theravance have announced plans to file a supplemental Japanese New Drug Application for the Relvar/Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD in the first quarter of 2016. The Japanese MHLW approved Relvar Ellipta for the treatment of asthma in patients 15 years old and older in September 2013. The companies also … [Read more...] about GSK and Theravance announce planned submission of Japanese sNDA for Relvar Ellipta
Nemera announces availability of Advancia nasal spray pumps
Nemera has announced that after investing over 10 million euros, it now has the capacity to manufacture up to 45 million units of the Advancia user-independent nasal spray pump per year. The company, which was previously known as Rexam Healthcare Devices, says that one European country has approved the Advancia drug product packaging. Advancia is compatible with … [Read more...] about Nemera announces availability of Advancia nasal spray pumps
RMIT University to display surface acoustic wave nebulizer
RMIT University, located in Melbourn, Australia, has announced that it will display the Respite surface acoustic wave nebulizer at TechInnovation 2015. According to RMIT, the device can deliver drug at rates of 3 ml/min, with no meshes or nozzles that could clog. The Respite nebulizer has the ability to deliver DNA, proteins, and peptides, and RMIT researchers … [Read more...] about RMIT University to display surface acoustic wave nebulizer