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Created: 03/04/2009 10:54:32 PM - Followers: 52 - Board type: Free - Posts Today: 0

Biodel, Inc., a development stage specialty pharmaceutical company, focuses on the development and commercialization of treatments for endocrine disorders, such as diabetes and osteoporosis in the United States. The company develops its product candidates by utilizing its proprietary VIAdel technology. It has two insulin product candidates in clinical trials for the treatment of diabetes, including VIAject and VIAtab. VIAject is an injectable formulation of recombinant human insulin, which is in pivotal Phase III clinical trials in patients with Type 1 and Type 2 diabetes. VIAtab is a sublingual tablet formulation of insulin, which is in Phase I clinical trial in patients with Type 1 diabetes. Biodel also has two preclinical product candidates for the treatment of osteoporosis comprising VIAmass, a sublingual formulation of parathyroid hormone 1-34; and VIAcal, a sublingual formulation of salmon calcitonin. The company was founded in 2003 and is based in Danbury, Connecticut.

3/15/2011 March 14, 2011, Biodel Inc. Announces Accelerated Development Plan for Ultra-Rapid-Acting Insulins

Biodel Inc. announced that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins. Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with Type 1 diabetes. This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog(R) each on separate occasions. This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog(R). In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year. If this Phase 1 study is successful, Biodel now anticipates initiating a Phase 2 study in patients with Type 1 diabetes in the fourth calendar quarter of 2011. The Phase 2 study is intended to follow the same overall design that would be implemented in Phase 3 studies, which would include two separate pivotal trials-- one in patients with Type 1 diabetes, and the other in patients with Type 2 diabetes. Biodel recently received initial guidance from the U.S. Food and Drug Administration (FDA) on the design of two pivotal Phase 3 clinical trials. Based on this guidance, Biodel plans to design the Phase 2 and 3 studies as randomized parallel group studies using Humalog(R) as a comparator in which active dose titration will occur in the first two months after randomization followed by three months of relatively stable dosing. In these studies, Biodel plans to evaluate efficacy using HbA1c as well as measures of postprandial glucose profiles. If the results of the Phase 2 testing are successful, the company plans to launch Phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013. 




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Is there any retail left in this company? historyperson 09/12/2021 07:10:12 PM
#2117 Really bad blood red market day for great Biggiee 07/19/2021 09:42:21 AM
#2116 PDUFA date July 20 mcjodie 07/02/2021 11:57:47 AM
#2115 Hmmm… interesting $ALBO Biggiee 06/21/2021 02:57:42 PM
#2114 Just In: $ALBO Albireo Announces Proposed Public Offering whytestocks 09/08/2020 04:15:22 PM
#2113 BREAKING NEWS: $ALBO Albireo Phase 3 Trial Meets whytestocks 09/08/2020 10:31:23 AM
#2112 good morning bud, $ALBO big mover premarket $treet $inatra 09/08/2020 08:02:12 AM
#2111 ALBO > 14M trading float > up 70%. crudeoil24 09/08/2020 07:38:49 AM
#2110 News: $ALBO Albireo Presents Data on A4250 in whytestocks 04/13/2019 08:00:36 AM
#2109 PERCEPTIVE ADVISORS LLC has filed a new 13G, wiltonio 06/05/2017 08:49:25 AM
#2108 Satter Muneer A has filed a new 13G, wiltonio 05/30/2017 12:59:19 PM
#2107 Coverage. Short time after recommendation by Blair & paulsbest 02/16/2017 08:45:07 AM
#2106 $$$ BUY RECOMM AT $ 40 $$$ paulsbest 02/16/2017 08:42:36 AM
#2105 Albireo Pharma (ALBO) Presents at 19th Annual BIO Ross92 02/14/2017 02:49:18 PM
#2104 Some solid buying today. I like that Ross92 01/03/2017 07:40:46 PM
#2103 now expects to plan the path for a cashcow3 12/22/2016 08:57:19 AM
#2102 albo trending !! cashcow3 12/22/2016 08:43:45 AM
#2101 premarket looking close... cashcow3 12/22/2016 08:38:10 AM
#2100 my prediction til eow is gap close about cashcow3 12/22/2016 06:25:46 AM
#2099 Albireo now expects to plan the path for cashcow3 12/22/2016 06:24:55 AM
#2098 cashcow3 12/22/2016 06:12:15 AM
#2097 new FORM 8-K cashcow3 12/22/2016 05:27:42 AM
#2096 Same recent movement has me cringing afternI added.. Ross92 12/21/2016 11:49:42 PM
#2095 Biod days. beeboispiggs 12/21/2016 05:21:06 PM
#2094 That would be awesome. I've been waiting on Ross92 12/18/2016 05:36:42 PM
#2093 If we could get some analyst coverage it beeboispiggs 12/18/2016 05:00:41 PM
#2092 Come on alboooooo Ross92 12/15/2016 05:16:31 PM
#2091 Looks like we found so solid support around Ross92 12/09/2016 01:46:29 AM
#2090 ALBO bullish 26.90 stocktrademan 11/23/2016 11:31:04 AM
#2089 With the 30:1 RS, BIOD is now trading Rymankoly 11/21/2016 12:08:04 PM
#2088 Albireo announced positive top line phase 3 results Inspector Clouseau 11/17/2016 01:39:24 PM
#2087 The institutions are filing their holdings and they Inspector Clouseau 11/17/2016 12:36:07 PM
#2086 The spike today? What is it from..!?! I Ross92 11/17/2016 10:40:08 AM
#2085 There is about 8 million shares outstanding which Inspector Clouseau 11/16/2016 11:09:34 AM
#2084 A 10 bagger? For real?? I like the Ross92 11/16/2016 10:51:06 AM
#2083 ALBO CHARTS PIRAT 11/16/2016 08:17:44 AM
#2082 I think it depends on how this plays Inspector Clouseau 11/16/2016 02:41:04 AM
#2081 What could the pps possibly go to though.. Ross92 11/16/2016 12:21:11 AM
#2080 ALBO up 12%+ on EMA (PRIME) acceptance djpope 11/15/2016 04:40:36 PM
#2079 We had good news today,it was about the Inspector Clouseau 11/15/2016 02:58:51 PM
#2078 Thanks I don't have a lot of money Billthegoat 11/10/2016 04:23:29 PM
#2077 I think somethings up,somebody could be driving the Inspector Clouseau 11/10/2016 04:18:22 PM
#2076 Hey inspector Give me your thougts Billthegoat 11/10/2016 04:02:38 PM
#2075 Thank you,Its also a pleasure talking to you.I'll Inspector Clouseau 11/04/2016 08:34:08 PM
#2074 Nice to talk with you. Let's keep an Billthegoat 11/04/2016 06:50:40 PM
#2073 I'm holding too,maybe it shoots up in a Inspector Clouseau 11/04/2016 06:47:44 PM
#2072 If you look it up on etrade there Inspector Clouseau 11/04/2016 06:40:57 PM
#2071 I agree. Just going to hold for a Billthegoat 11/04/2016 06:39:18 PM
#2070 I think it may be a good long Inspector Clouseau 11/04/2016 06:32:45 PM
#2069 Looks like it's going down. Not sure this Billthegoat 11/04/2016 03:59:24 PM
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