August 2012
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Apple has announced that its new ResearchKit open source software framework intended to help medical researchers collect patient data will be available next month, and the company has introduced a suite of apps used to… Read more . . .
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The FDA has tentatively approved Teva’s ProAir RespiClick albuterol dry powder inhaler as of March 5, 2015. Teva filed an NDA for an albuterol “MDPI” (multi-dose dry powder inhaler) for the treatment of asthma in… Read more . . .
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The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers. In the US, Boehringer Ingelheim markets its ipatropium MDI for the treatment of COPD under the brand… Read more . . .
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Data to be presented at the upcoming annual meeting of The Endocrine Society show that healthy men treated with intranasal oxytocin consumed fewer calories and had reduced insulin sensitivity after use of the nasal spray.… Read more . . .
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Zhejiang Juhua has announced that the US FDA accepted a drug master file (DMF) for pharmaceutical-grade HFA 134a submitted by its fluorochemicals subsidiary on December 26, 2014 and that the company also received accreditation for… Read more . . .
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The UK’s Prescription Medicines Code of Practice Authority (PMCPA) has reprimanded Chiesi for a misleading and unsubstantiated claim regarding the company’s Fostair beclometasone/formoterol inhaler. The authority has published advertisements in the BMJ, The Pharmaceutical Journal,… Read more . . .
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Adamis Pharmaceuticals has announced that data from a Phase 1 PK study its APC-5000 fluticasone/salmeterol DPI, a generic carrier-free version of Advair Diskus, show less systemic exposure to both components compared to Advair. The open-label… Read more . . .
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In its announcement of fourth quarter and full year financial results for 2014, Insmed has confirmed that it filed an MAA for Arikayce liposomal amikacin inhalation solution. The company said that the EMA’s Pediatric Committee… Read more . . .
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Australia’s Therapeutic Goods Administration (TGA) has issued a warning about devices marketed by a company called Discreet Vape that look nearly identical to metered dose inhalers used for rescue medications for asthma. The PUFFiT and… Read more . . .
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Several months after Retrophin announced that it would divest several of its pipeline products, including Syntocinon intranasal oxytocin and intranasal ketamine, to Turing Pharmaceuticals, the latter company has officially announced its launch. Turing Pharmaceuticals is… Read more . . .
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