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”
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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
FDA approves Spiriva Respimat for the treatment of asthma
Boehringer Ingelheim's Spiriva Respimat tiotropium soft mist inhaler has now been approved by the FDA for the treatment of asthma in patients 12 years old and older. Spiriva Respimat was approved for the treatment of COPD in the US in September 2014, and it is currently approved for the treatment of asthma in over 50 countries. Boehringer Ingelheim Head of … [Read more...] about FDA approves Spiriva Respimat for the treatment of asthma
Mylan and Theravance Biopharma initiate Phase 3 trials of revefenacin for COPD
Theravance Biopharma and Mylan announced that they have initiated Phase 3 studies for TD-4208 revefenacin inhalation solution for the treatment of COPD. The Phase 3 program includes 2 12-week efficacy studies plus a 12-month safety study and is expected to enroll 2,300 patients. The two companies announced in February 2015 that they would partner on development of the … [Read more...] about Mylan and Theravance Biopharma initiate Phase 3 trials of revefenacin for COPD
AZTherapies begins Phase 3 study of inhaled Alzheimers therapy
AZTherapies announced that it has initiated a Phase 3 study of its ALZT-OP1 DPI for the treatment of early stage Alzheimer's disease. ALZT-OP1 is a dry powder formulation of cromolyn and ibuprofen that is delivered by a proprietary inhaler called Azhaler-D; AZTherapies licensed the technology from Massachusetts General Hospital. The company said that it plans to be … [Read more...] about AZTherapies begins Phase 3 study of inhaled Alzheimers therapy
FDA accepts Teva’s sNDA for ProAir Respiclick for pediatric use
Teva has announced the FDA's acceptance of a supplemental new drug application (sNDA) for the ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 4 to 11. The FDA approved ProAir RespiClick for the treatment of asthma in patients 12 and older in March 2015. Teva Senior VP, Teva Global Respiratory R&D, Tushar Shah commented, “The acceptance … [Read more...] about FDA accepts Teva’s sNDA for ProAir Respiclick for pediatric use