Results from the CLAIM study published online in Lancet Respiratory Medicine on February 21, 2018 show that COPD patients using Novartis's Ultibro Breezhalerindacaterol/glycopyrronium DPI had significantly decreased lung hyperinflation and improved cardiac function after 14 days compared to placebo. Ultibro Breezhaler has been approved for the treatment of COPD in … [Read more...] about Study shows improved cardiac function for COPD patients using Ultibro Breezhaler
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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
FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation
AstraZeneca has announced that the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of FluMist Quadrivalent intranasal live Influenza vaccine for the 2018-19 flu season based on positive results of a new study in children aged 2-4 years old. FluMist Quadrivalent was approved by the … [Read more...] about FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation
Lonza announces addition of DPI capsule filling capabilities
Lonza has announced the installation of a new Harro Hӧfliger Modu-C MS encapsulation unit at its product development and manufacturing facility in Tampa, FL. The company said that installation and validation of the unit are expected to be complete by the end of the month. Lonza also said that it expects to open a new dispensing area and processing suites for highly … [Read more...] about Lonza announces addition of DPI capsule filling capabilities
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
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