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Biodel Inc. (BIOD)

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Last Post: 9/10/2016 9:43:44 AM - Followers: 87 - Board type: Free - Posts Today: 0

 

http://finance.yahoo.com/q/ks?s=BIOD

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. 

  
  

Coverage:

http://finance.yahoo.com/q/ud?s=BIOD

Blogs:

http://seekingalpha.com/article/227766-biodel-upside-from-potential-linjeta-approval?source=yahoo

http://seekingalpha.com/article/225291-biodel-s-linjeta-should-overcome-the-usual-fda-approval-hurdles?source=yahoo

 
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BIOD News: Additional Proxy Soliciting Materials (definitive) (defa14a) 09/22/2016 06:03:59 AM
BIOD News: Current Report Filing (8-k) 09/22/2016 06:03:39 AM
BIOD News: Proxy Statement - Merger or Acquistion (definitive) (defm14a) 09/19/2016 04:45:09 PM
BIOD News: Proxy Soliciting Materials (revised) (prer14a) 09/12/2016 06:03:23 AM
BIOD News: Current Report Filing (8-k) 09/09/2016 04:09:20 PM
PostSubject
#2010   Biod entered into. Licensing and asset purchase w TOM611 09/10/16 09:43:44 AM
#2009   Woah.. some activity in the aftermarket... Ross92 09/09/16 11:47:01 PM
#2008   Not sure but I think in near future Billthegoat 09/08/16 11:26:49 AM
#2007   That's old news. Do we know where they Ross92 09/08/16 10:54:43 AM
#2006   Very good investment...... That's what I was thinking Billthegoat 09/08/16 07:55:03 AM
#2005   Merger with Albireo! : qu1111 09/08/16 07:52:58 AM
#2004   I'm not sure but I thing they are Billthegoat 09/08/16 06:46:01 AM
#2003   On a side note I do notice a Ross92 09/08/16 01:28:42 AM
#2002   Can anyone tell me or does anyone know Ross92 09/08/16 01:22:53 AM
#2001   Is this a good move? Billthegoat 08/22/16 11:11:48 AM
#2000   BIOD: STEM-clone on merger. Naked shorts in trouble...eom. remind2 08/17/16 09:17:57 AM
#1999   Has symbol change already occurred? nsomniyak 08/17/16 08:13:25 AM
#1998   Biodel Inc.(BIOD) AH Trading $.43990 +.0498 +12.77% djpope 08/16/16 08:46:16 PM
#1997   STEM deal puts BIOD InPlay. New Nasdaq ticker remind2 08/16/16 06:14:23 PM
#1996   BIOD @ .4498 getting serious action now in AHs Ricky-D 08/16/16 06:13:43 PM
#1995   That's old news and any jump in share Samgot7 08/16/16 06:00:42 PM
#1994   http://www.streetinsider.com/dr/news.php?id=11671838 MarketWiz152 08/16/16 05:12:52 PM
#1993   Got a link to that "PENDING MERGER" you NotRichYet2 08/16/16 05:02:45 PM
#1992   BIOD: Pending merger sets up a STEM-like move. remind2 08/16/16 04:36:38 PM
#1991   BIOD WOW 60,000 @ 0,4099 Ricky-D 08/04/16 12:34:50 PM
#1990   Whats going on right now? Is there something Ross92 07/28/16 10:58:46 AM
#1989   BIOD bullish 0.4165 stocktrademan 07/27/16 10:08:40 AM
#1988   yep Ricky-D 07/27/16 09:40:07 AM
#1987   If she breaks .40 and continues should be ClearlyStocks 07/27/16 09:18:23 AM
#1986   Breakout imminent Ricky-D 07/27/16 09:13:27 AM
#1985   Gapping up p/m ClearlyStocks 07/27/16 06:51:13 AM
#1984   Bid buys .40 ClearlyStocks 07/26/16 03:53:50 PM
#1983   Good action today +.03 Ricky-D 07/26/16 03:21:14 PM
#1982   BIOD WEEKLY CHARTS PIRAT 07/26/16 03:58:40 AM
#1981   BIOD CHART PIRAT 07/26/16 03:50:04 AM
#1980   .30s ClearlyStocks 07/22/16 11:44:09 AM
#1979   Might go ClearlyStocks 07/22/16 11:44:03 AM
#1978   it never ran.... IN The Mouth Of Madness 06/26/16 01:10:58 PM
#1977   * * $BIOD Video Chart 05-31-16 * * ClayTrader 05/31/16 04:45:47 PM
#1976   * * $BIOD Video Chart 05-27-16 * * ClayTrader 05/27/16 04:16:52 PM
#1975   What a joke - look the chart picture above. Northwest 12 05/27/16 10:01:24 AM
#1974   * * $BIOD Video Chart 05-26-16 * * ClayTrader 05/26/16 04:27:04 PM
#1973   I'm out. Good luck for those that wait. inxxs 05/26/16 11:47:21 AM
#1972   R/S are a major buzzkill porgyrusty 05/26/16 11:44:38 AM
#1971   The longer you wait the better it will TOM611 05/26/16 11:26:27 AM
#1970   Yeh, I waited all these months for this? inxxs 05/26/16 11:13:58 AM
#1969   That kills all chance of making any money gman55423 05/26/16 11:00:43 AM
#1968   Looks like they're just considering the option for now. SPM555 05/26/16 10:07:41 AM
#1967   Here's link. 30-1 get the price way over porgyrusty 05/26/16 09:50:43 AM
#1966   30-for-1 reverse stock split reggabnet 05/26/16 09:23:04 AM
#1965   ;) BIOD desandan 05/26/16 06:18:16 AM
#1964   push push push, lol. bernice 05/26/16 03:09:33 AM
#1963   think today 1 $ is done easily......yesterday people cashcow3 05/26/16 02:37:48 AM
#1962   this share can erupt at any time...Albireo is cashcow3 05/26/16 02:35:03 AM
#1961   Albireo has an excellent reputation and many successes cashcow3 05/26/16 02:34:16 AM
PostSubject