Biodel

FDA grants Biodel orphan drug designation for rare insulin disease

Friday, December 7, 2012 02:34 PM

The FDA has given special designation to glucagon, developed by specialty pharmaceutical company Biodel,for patients with congenital hyperinsulinism (CHI), or abnormally low blood sugar—a rare disorder that affects children.

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Biodel awarded NIH grant to develop ultra-rapid-acting insulin for artificial pancreas

Thursday, July 26, 2012 10:42 AM

The Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH) has awarded Biodel, a Danbury, Conn.-based specialty biopharmaceutical company, a grant for the development of concentrated ultra-rapid-acting insulin formulations for use in an artificial pancreas, also known as a closed loop pump system.

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Biodel plans insulin trials

Wednesday, March 16, 2011 01:56 PM

Biodel 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 I clinical trial of approximately 18 patients with Type I diabetes.

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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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