Navigation Links
FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta™
Date:11/1/2010

addition, the FDA identified resolution of manufacturing issues related to recent site inspections at Hyaluron, Inc. and Wockhardt, Ltd. as a requisite for approval.

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward.  We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes."

Biodel's senior management will host a conference call today to discuss the CRL.8:15 am EDT:

Conference call participants should dial: +1 (877) 303 - 8028 (United States) or +1 (760) 536 - 5167 (International) 8:30 pm EDT:

Conference call begins About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes. Biodel's product candidates are developed using VIAdel™ technology, which reformulates existing FDA-approved peptide drugs.  Linjeta™ is Biodel's most advanced product candidate, which has been reviewed by the FDA and issued a complete response letter.  Earlier-stage product candidates include VIAtab™, a sublingual tablet formulation of insulin, a line of basal insulins, and a stabilized formulation of glucagon. For further information regarding Biodel, please visit the company's website at www.biodel.com.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements include statements about future activities related to the complete response letter regarding the company's new drug application for Linjeta™; the company's response to the complete resp
'/>"/>

SOURCE Biodel Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
2. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
3. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
6. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Tianyin Pharmaceutical Co., Inc. (NYSE MKT: ... biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics ... the Company achieved the Public Notice (Gong Shi) ... of TPI,s Qionglai Facility (QLF) from the China ... period is a significant procedure of GMP certification ...
(Date:12/24/2014)... , Dec. 23, 2014  Endo Pharmaceuticals Inc., ... ENDP ) (TSX: ENL), and BioDelivery Sciences International, Inc. ... have submitted a New Drug Application (NDA) for Buprenorphine ... Administration (FDA).  Buprenorphine HCl Buccal Film is under development ... daily, around-the-clock, long-term opioid treatment and for which alternative ...
(Date:12/22/2014)... , Dec. 22, 2014  CytoSorbents Corporation ... its CytoSorb® blood purification technology to help fight ... in 28 countries worldwide, today announced the appointment ... MD, FACS, as its Senior Vice President of ... Dr. Di Russo is an ...
Breaking Medicine Technology:TPI QLF Achieved Public Notice Status of GMP Certification 2TPI QLF Achieved Public Notice Status of GMP Certification 3Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 2Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 3Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 4Endo Pharmaceuticals and BioDelivery Sciences Announce NDA Submission for Buprenorphine HCl Buccal Film for the Management of Moderate to Severe Chronic Pain 5CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 2CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 3CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 4CytoSorbents Appoints Dr. Gregory B. Di Russo as Senior Vice President of Clinical Development 5
... 1st to the 3rd of March 2011, vaccine leaders ... World Summit in New Delhi. The event will be ... Vaccine Manufacturers Network). Participants will be discussing ... pandemic surveillance programs, low cost and fast vaccine manufacturing ...
... 2010 A new analysis of the effects of ... treatment options for tens of millions of people with ... certain food or nutritional supplements but not manufactured by ... a role in optimal brain functioning and have antidepressant ...
Cached Medicine Technology:World Vaccine Leaders to Meet in New Delhi India to Tackle Global Public Health Challenges 2Omega-3 Supplements Show Promise in Alleviating Depression 2
(Date:12/26/2014)... Plugin and template developers from Pixel ... for Final Cut Pro X. , “TransPack Volume 5 gives ... pull off an industry professional look” Said Christina Austin, CEO ... TransPack Volume 5, a new level of professionalism will become ... over 50 Final Cut Pro X transitions featuring organic animations. ...
(Date:12/26/2014)... (PRWEB) December 26, 2014 India Network ... insurance in the USA, announced today a new version ... members in choosing the right plan for their visiting ... complexity out of the selection process when choosing an ... age group with only a few clicks. Many elderly ...
(Date:12/26/2014)... DW-InductionHeating.com (DaWei Induction Heating Co.) is a comprehensive ... and marketing of a series of induction heating equipment. ... series of induction brazing equipments . , According ... brazing refers to the joining of two or ... The manager says that there are fundamental differences in ...
(Date:12/25/2014)... The microscopy market is estimated ... reach $5,756.0 million by 2019. Optical microscopy is ... electron microscopes product segment is expected to show ... Rising focus on nanotechnology, technological advancements, and increasing ... market. , Get Full Copy of Report @ ...
(Date:12/25/2014)... The click strand woven bamboo ... durability. Today, the business announces a click strand ... Jan. 30, 2015. , Click strand woven bamboo ... is a well-known brand in the bamboo industry. ... a reliable bamboo flooring supplier. , “We are ...
Breaking Medicine News(10 mins):Health News:Today a new plugin was announced from Pixel Film Studios, TransPack Volume 5 for Final Cut Pro X 2Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 2Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 3Health News:Induction Brazing Equipment Series From DaWei Induction Heating Co., A Reliable Supplier Of Induction Heating Equipment 2Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 2Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 3Health News:Microscopy Market Hit to $5,756.0 Million by 2019 - New Research Report by MarketsandMarkets 4Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2
... between Uttar Pradesh Government Railway Police and Junior doctors ... Meerut by Meerut Nauchandi Express lead to injuring medicos ... the police personnel occupying the reserved seats of the ... seven state medical colleges for three days ordering enquiry ...
... appearing in the January 18 issue of The Journal of ... when adult neurons try to undergo division. This finding in ... development of the disease. ,"If you could ... from dying prematurely. This could be a fresh approach to ...
... are of the opinion that interstellar dust coming into our ... significance. The results have exceeded all expectations, according to Donald ... principal investigator, or lead scientist, for Stardust. ‘It's a huge ... ones, there are small ones’, he said. ...
... medicines will no longer be available to Canadians from supermarkets ... are aimed at preventing addicts from making crystal meth. //The ... be affected by the ban which will come into force ... sell about 15 medicines which are of the single ingredient ...
... masala and tobacco products near hospitals and educational institutions by the ... from beyond 500 meters from such institutions, according to the new ... that this is strictly adhered to. ,The youth ... product due its low price and easy availability. Children are also ...
... call to bedside phones cost higher than the call made ... charges levied on the bedside phones. // ... complaining of the bedside phone charges. ,The company ... the peak time costed around 49p per minute and at ...
Cached Medicine News:Health News:Dividing Nerve Cells Could Trigger Alzheimer's Disease 2Health News:Ofcom To Assess The Bedside Call Charges 2
... 1-step, hand-held, point-of-care device for the qualitative detection ... The TOX/See device can detect up to ... 3 to 8 minutes and requires only a ... individually packaged to maximize convenience and ease of ...
... Light System offers the newest, brightest, ... ever created. Available exclusively from ... get extremely bright, powerful, long-lasting illumination ... your practice demands. With a class ...
... Manual Rack is a manual Modified ... erythrocyte sedimentation rate (ESR) of whole ... Streck ESR-Vacuum Tubes. The rack will ... The ESR-10 Manual Rack exhibits >96% ...
Streck Cytometry Sheath fluid is a ready-to-use, balanced isotonic solution for use on flow cytometers. It is packaged in a 20 liter Cubitainer, and offers a two-year shelf life....
Medicine Products: