Send by TheStreet.com

Bydureon delay reduces peak potential and cash flow outlook. Price target sunk to $16 from $30. Amylin Pharmaceuticals (AMLN) downgraded at Citigroup from [...]

Send by Toronto Star

The FDA's request will delay a potential launch of Bydureon by 18 months or more, and the increasing conservatism of regulators lessens the probability of [...]

Send by Empowered News

The US Food and Drug Administration on Tuesday rejected new diabetes medication Bydureon for lack of clinical data, specifically about how the drug affects [...]

Send by Wall Street Journal

The regulator's request for more data to examine the effect of high doses of the drug, called Bydureon, on heart rhythms, likely pushes potential approval [...]

Send by Proactive Investors USA & Cana

Alkermes (NASDAQ:ALKS) also posted losses on the Bydureon news, dropping by almost 27%. Alkermes developed the technology to allow the drug to be used in a [...]

Send by Wall Street Journal

The delay is a big setback for the trio, likely pushing out potential approval of the experimental therapy Bydureon to 2012. The drug has blockbuster [...]

Send by Seeking Alpha

Now onto what most ALKS investors really want: approval of Bydureon. Bydureon is by far the most important asset (pdf) for ALKS. Bydureon can fight off Novo [...]

16 Jun 2010 Mixed Results for Bydureon-The co-developers of type II diabetes candidate Bydureon (exenatide once weekly), announced mixed results from [...]

29 Jun 2010 Recently Alkermes Inc. ], Amylin Pharmaceuticals Inc. ] and Eli Lilly & Co. ], the co-developers of type II diabetes candidate Bydureon [...]

26 Jun 2010 BYDUREON(TM) Safety and Tolerability Pooled Summary Data Presented at ADA 2010. Data from Nearly 1100 Patients in DURATION-1, -2 and -3 [...]

15 Jun 2010 Diabetes drug tops one oral drug, comparable to 2 others * Bydureon longer-lasting version of Byetta * Amylin shares down nearly 4 pct By [...]

"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option [...]

16 Jun 2010 Shares of Amylin Pharmaceuticals dipped after the developer posted disappointing data from a new trial showing that its closely watched [...]

20 Oct 2010 In a stunner, Amylin, Alkermes and Eli Lilly have been handed a major setback in their long quest to get the new, once-weekly diabetes [...]

"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option [...]

20 Oct 2010 NEW YORK (Reuters) - Amylin Pharmaceuticals' shares lost half their value in premarket trading on Wednesday, after US regulators declined to [...]

"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option [...]

Send by Maureen Martino

Amylin, Eli Lilly and Alkermes have received an FDA complete response letter for Bydureon, but the companies note in an announcement that there are no requests for new pre-clinical or clinical Read more [...]

Send by R J Steffens

An EASD 2010 abstract funded by Amylin and Eli Lilly for Byetta and Bydureon, titled "Antibodies to Byetta did not Cross-React with Human GLP-1 or Glucagon or Alter the Efficacy or Safety of Exenatide", is interesting. [...]

Send by MarketWatch

Later this week, US regulators are expected to decide whether to approve Amylin Pharmaceuticals's (NASDAQ:AMLN) Bydureon, a long-acting formulation of the [...]

Send by David Phillips

Novo has to move quickly to build its market position, as the FDA is expected to issue an opinion on a more convenient dose of Byetta, a once-weekly injection called Bydureon, by October 22. Pending an approvable letter, analysts are [...]

Recently Alkermes Inc. (NASDAQ:ALKS), Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) and Eli Lilly & Co. (NYSE:LLY), the co-developers of type II diabetes candidate Bydureon [...]

(Nasdaq: ALKS) today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, [...]

It has emerged that the new injectable diabetes drug, taspoglutide, which is being developed by two pharmaceutical companies, Roche and Ipsen, has had its late stage clinical trials suspended due to fears over possible side effects. The drug was causing a high proportion of gastrointestinal reaction [...]

Send by Jack Shu

Amylin Pharmaceuticals (NASDAQ: AMLN) has received positive results regarding Bydureon, its type 2 diabetes treatment. The drug was found to lower fasting glucose levels, help digest food, and signal to an individual that they have [...]