Savara has announced that the Phase 2 INDIE study of Aironite sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) failed meet its primary endpoint and, as a result, the company is discontinuing development of the product. Mast Therapeutics acquired Aironite when it acquired Aires Pharmaceuticals in 2014; … [Read more...] about Savara discontinues development of Aironite after Phase 2 trial fails to meet primary endpoint
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Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries
Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices not delivering the full number of doses in the device,” the MHRA announced a recall of 2 lots of Ventolin Accuhaler and 1 lot of Seretide Accuhaler in the UK due to the same issue. … [Read more...] about Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries
HCmed partners with Pharos to market the Deepro vibrating mesh nebulizer in Indonesia
HCmed has announced that a partnership with pharmaceutical company Pharos Indonesia has led to approval for its Deepro vibrating mesh nebulizer from the Indonesian National Drug and Food Control Agency (BPOM), and the companies will now launch the Deepro device in Indonesia. Earlier this year, HCmed announced that it had received a strategic investment from Vivo … [Read more...] about HCmed partners with Pharos to market the Deepro vibrating mesh nebulizer in Indonesia
Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension
The US Patent and Trademark Office has issued US Patent Number 9,895,385, titled "Methods for treating pulmonary non-tuberculous mycobacterial infections" to Insmed Incorporated, the company said. According to Insmed, the patent is the 9th for ALIS and extends patent coverage for the formulation from January 2034 to May 2035. The patent covers the use of nebulized … [Read more...] about Insmed gets additional US patent for ALIS amikacin liposome inhalation suspension
GSK recalls lot of Ventolin Diskus in Canada
GSK has voluntarily recalled one lot of Ventolin Diskus 200 μg salbutamol (albuterol) DPIs in Canada due to "a manufacturing issue that may result in a small number of Ventolin Diskus devices not delivering the full number of doses in the device," the company said. The lot recalled is number 786G. According to GSK, the root cause of the manufacturing issue has … [Read more...] about GSK recalls lot of Ventolin Diskus in Canada
Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose
Opiant Pharmaceuticals has announced that, based on feedback from the FDA and positive data from a Phase I clinical study, the company plans to pursue a 505(b)(2) development path for its OPNT003 intranasal nalmefene for the treatment of opioid overdose. OPNT003 is formulated using Aegis Therapeutics' Intravail absorption enhancer, which Opiant licensed in 2017. … [Read more...] about Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose
Teva launches QVAR RediHaler in the US
Teva Pharmaceutical Industries has announced the US launch of its QVAR RediHaler beclomethasone dipropionate HFA MDI, which was approved by the FDA in August 2017 for the treatment of asthma in patients aged 4 years and older. The RediHaler is a breath actuated device and requires no shaking or priming. The company is discontinuing sales of the previous version of … [Read more...] about Teva launches QVAR RediHaler in the US
OraPharma to co-promote Sprix nasal spray in the US
Egalet Corporation has terminated a co-promotion agreement with Septodont, the company said, and is now partnered with Valeant's OraPharma division for co-promotion of Sprix ketorolac tromethamine nasal spray to US dentists and oral surgeons. Sprix has been approved by the FDA since 2010 for short-term treatment of moderate-to-severe pain. Under the terms of the … [Read more...] about OraPharma to co-promote Sprix nasal spray in the US
Huons reportedly licenses budesonide/salmeterol DPI from Laboratoires SMB
According to Korea Biomedical Review, Korean pharmaceutical company Huons has licensed Zephirus busesonide/salmeterol, a dry powder formulation delivered using the Axahaler capsule-based inhaler, from Belgian pharmaceutical company Laboratoires SMB. Korea Biomedical Review reported that Huons CEO Um Key-an commented, “Respiratory disease is a disease that greatly … [Read more...] about Huons reportedly licenses budesonide/salmeterol DPI from Laboratoires SMB
Iconovo signs development and licensing agreement with Intas Pharmaceuticals for DPI
Iconovo AB announced that it has signed an agreement with Intas Pharmaceuticals for development and licensing of a DPI for the treatment of asthma and COPD, including the dry powder formulation and a device based on Iconovo's ICOres reservoir inhaler. According to Iconovo, the deal is worth €2.8 million and includes royalties. In June 2017, Iconovo announced the … [Read more...] about Iconovo signs development and licensing agreement with Intas Pharmaceuticals for DPI