{"id":33058,"date":"2013-06-06T09:18:51","date_gmt":"2013-06-06T13:18:51","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=33058"},"modified":"2015-12-30T03:26:17","modified_gmt":"2015-12-30T08:26:17","slug":"biodel-to-produce-glucagon-rescue-product","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=33058","title":{"rendered":"Biodel to Produce Glucagon Rescue Product"},"content":{"rendered":"
\"\"<\/a>Biodel has\u00a0announced plans to submit a New Drug Application (NDA) to the\u00a0FDA\u00a0in 2015 for a novel glucagon rescue device to treat severe hypoglycemia.<\/div>\n
\n

Having previously signed a long-term commercial supply agreement for bulk glucagon,\u00a0Biodel\u00a0expects to select a final formulation of its novel glucagon therapy and appoint a contract manufacturing partner during the current calendar quarter. The submission of an Investigational New Drug application to the\u00a0FDA\u00a0is expected during the next 12 months. Initiation of a pivotal clinical study is expected to occur during the second half of 2014, putting the Company in a position to file an NDA to the\u00a0FDA\u00a0under the 505(b)(2) regulatory pathway in 2015.<\/p>\n

\"Biodel<\/a><\/p>\n

In preparation for the anticipated regulatory filing and commercial launch of its glucagon rescue product,\u00a0Biodel\u00a0has signed a 15-year supply agreement with\u00a0Unilife Corporation\u00a0for a customized proprietary device from its EZMix\u2122 platform of dual-chamber devices with worldwide exclusivity for use with glucagon. The device has been customized for convenient portability and ease of use to enable rapid treatment during emergency situations with little to no training. The device automatically reconstitutes lyophilized glucagon when prepared for injection and features automatic, user-controlled retraction of the needle upon full dose delivery, virtually eliminating dosing errors and the risk of needle stick injuries.\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Biodel has announced plans to submit a New Drug Application (NDA) to the FDA in 2015 for a novel glucagon rescue device to treat severe hypoglycemia.
\nHaving previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy…<\/p>\n","protected":false},"author":131,"featured_media":33059,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1443,1445],"tags":[488,925,899],"yoast_head":"\nBiodel to Produce Glucagon Rescue Product<\/title>\n<meta name=\"description\" content=\"The new glucagon rescue product features automatic, user-controlled retraction of the needle upon delivery, 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