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
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Molins Technologies is now Mpac Langen
Molins PLC, the parent company of automated filling and packaging company Molins Technologies, has announced a name change to Mpac Group. All of the businesses in the group will now be joined into a single brand called "Mpac Langen." According to Mpac, "The name ‘Mpac’ was chosen as a name grounded in the company’s rich heritage, focused on the future as a global … [Read more...] about Molins Technologies is now Mpac Langen
FDA accepts Acorda’s new NDA for Inbrija inhaled levodopa
The FDA has accepted Acorda Therapeutics' revised NDA for Inbrija inhaled levodopa for the treatment of symptoms associated with OFF periods in Parkinson’s disease in patients taking carbidopa/levodopa, the company said. The PDUFA target date is October 5, 2018. In August 2017, the FDA issued a refuse-to-file letter in response to Acorda's initial 505(b)(2 ) NDA … [Read more...] about FDA accepts Acorda’s new NDA for Inbrija inhaled levodopa
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
GSK submits type II variation application in Europe for expanded use of Trelegy Ellipta
GlaxoSmithKline and Innoviva have announced the submission of a type II variation application seeking expanded use for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI for the treatment of COPD. Trelegy Ellipta was granted marketing authorization in Europe in November 2017. In the US, the FDA initially approved Trelegy Ellipta for … [Read more...] about GSK submits type II variation application in Europe for expanded use of Trelegy Ellipta
Amiko announces strategic investment from Sanner, gets CE mark for Respiro platform
Sanner Ventures and Amiko Digital Health have announced a deal in which Sanner will make a strategic investment in further development of Amiko’s Respiro dry powder inhaler monitoring platform. Amiko also announced that the Respiro platform has received the CE mark for use with the Spiromax, Nexthaler, and Ellipta inhalers. According to Amiko, the company has … [Read more...] about Amiko announces strategic investment from Sanner, gets CE mark for Respiro platform
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
Savara’s IND for Moldgradex study approved
According to Savara, the FDA has approved an IND the company submitted for Molgradex, an inhaled molgramostim (recombinant human GM-CSF) formulation for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), which the company filed in December 2017. The approval allows the company to enroll patients in the ongoing Phase 3 IMPALA study at sites in the … [Read more...] about Savara’s IND for Moldgradex study approved
Propeller Health gets ISO 13485:2016 certification
Inhaler monitoring company Propeller Health has received ISO 13485:2016 certification for medical device quality management systems, the company announced. Propeller cited the ISO certification as a milestone along with its recently announced agreement with Express Scripts and expanded partnership with GSK. Propeller Health Regulatory and Quality Assurance … [Read more...] about Propeller Health gets ISO 13485:2016 certification