Recently, Alkermes Inc. (ALKS) announced that its pipeline candidate, ALKS33, for addiction and nervous system disorders, gave positive results in two early stage clinical trials. Results from the two studies, ALK33-003 and ALK33-004, demonstrated that the candidate blocked the effects of an opioid with an action duration that supported once daily dosing.  The studies were initiated in May this year. ALK33-003, a randomized, double-blind, placebo-controlled, multi-dose study, evaluated the pharmacokinetics, safety and tolerability of multiple doses of ALKS33 in 30 healthy volunteers. ALK33-004, a randomized, single-blind, placebo-controlled, single-dose study, was designed to examine the ability of ALKS33 to block the effects of an opioid following a single oral dose of ALKS33 in 24 healthy, non-dependent, opioidexperienced subjects.  ALKS33, an oral opioid modulator, was generally well-tolerated in both the studies. The company intends to move the candidate into mid-stage studies by the end of this calendar year. ...

Last week, Merck (MRK) received a favorable opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin). The committee recommended the drugs to be used as add-ons to insulin for the treatment of type 2 diabetes.

In the US, a supplemental New Drug Application (sNDA) for the use of Januvia and Janumet in combination with insulin has been accepted by the FDA and is currently under review.

While the favorable opinion from the committee is good news, we remain concerned about the risk of inflamed pancreas for patients treated with Januvia or Janumet. Although the company officials refuse to accept the link, the FDA has stated that 88 cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis, had been reported since the drug's approval in October 2006 through February 2009. Among

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Dr Stock Pick HOT News & Alerts!

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FREE Daily Stock Alerts From DrStockPick.com

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Friday September 25, 2009

DrStockPick.com Stock Report!

CVAT, JNJ, CSRH, MRK, PWRM, MU

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CSRH, Consorteum Holdings Inc, CSRH.OB

CSRH is a company in the financial services, payment and transaction processing industries.

CSRH provides electronic transaction processing and management services to financial institutions, healthcare, government, public and private sector companies. CSRH’s services provide customized, innovative technology solutions that create, augment and enhance customers’ existing financial, payment and transactional processing systems.

CSRH has established an agreement with a third party partner within the payment processing industry to offer Merchant Discount Rates. Consorteum will leverage this new partnership to offer competitive Merchant Discount Rates and Point of

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On July 20, 2009, Amylin Pharmaceuticals Inc., (AMLN), Eli Lilly and Company (LLY) and Alkermes Inc. (ALKS) announced that their co-developed drug for type II diabetes, Exenatide once weekly was more effective in reducing average blood sugar over three months compared to Sanofi-Aventis' (SNY) Lantus (insulin glargine) on the basis of a 26-week open-label, clinical study in 467 patients with type II diabetes. Exenatide once weekly treatment also resulted in a mean weight loss of 5.8 pounds at 26 weeks, compared to a mean weight gain of 3.1 pounds for the Sanofi drug. This is again a desirable result as obesity is one of the primary causes of type II diabetes. Further, there were fewer cases of confirmed hypoglycemia (over-reduction in blood sugar) in patients treated with Exenatide once weekly compared to Lantus.  More than 23 million people in the U.S. are affected by diabetes, ...

Positive Results on LAR from DURATION-3 Study Yesterday, Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) announced positive results on exenatide once weekly long acting release (LAR) formulation from a phase III head-to-head study which compared LAR with Sanofi-Aventis’ (SNY) Lantus (insulin glargine). The 26 week study was conducted in type II diabetes patients (n=467) who were unable to achieve adequate glucose control on metformin therapy alone or in combination with a sulfonylurea. Results showed that LAR was more effective in reducing blood sugar levels compared to Lantus (6.8% vs. 7%). Moreover, patients on LAR therapy achieved a mean weight loss of 5.8 pounds compared with a mean weight gain of 3.1 pounds in patients treated with Lantus. This is important as data indicate that weight loss helps patients in their efforts to achieve and sustain glycemic ...

NDA acceptance not enough for Alkermes On July 7, 2009, Alkermes, Inc. (ALKS), Eli Lilly (LLY) and Amylin Pharmaceuticals, Inc. (ALNY) announced the acceptance of the New Drug Application (NDA) for once-a-week diabetes drug Exenatide by the U.S. Food and Drug Administration (FDA). Exenatide once weekly is being co-developed by the three companies for type II diabetes. The application was filed by Alkermes in May 2009. Exenatide is an active ingredient of Byetta injection. It is presently available in the U.S. and in many countries across the globe as a treatment for type II diabetes patients who fail to achieve good glycemic control with commonly available oral therapies. Byetta is injected twice a day as against the once a week administration of the proposed drug. If approved, Exenatide once weekly would be the first and only once-a-week therapy for the treatment of ...

For Immediate Release

Chicago, IL - June 9, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Amylin Pharmaceuticals (AMLN), Merck (MRK), Glaxo (GSK), Bristol (BMY) and Eli Lilly (LLY).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Monday's Analyst Blog:

Amylin Update Post ADA Meeting

This past weekend, Amylin Pharmaceuticals (AMLN) presented several abstracts and oral presentations at the American Diabetes Association (ADA) meeting in New Orleans. At the meeting, Amylin presented long-term follow-up data from the 74-week open label portion of the DURATION-1 program that demonstrated

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Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

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Highlights include Novo Nordisk (NVO), Alkermes, Inc. (ALKS), Eli Lilly & Co. (LLY) and Amylin Pharmaceuticals, Inc. (AMLN).  Early this morning, Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly (LLY) and Alkermes (ALKS) announced that a New Drug Application (NDA) for Exenatide once weekly for type II diabetes has been submitted to the US FDA. Exenatide once weekly is an investigational sustained release medication for type II diabetes that is injected subcutaneously and administered only once a week. Exenatide is the active ingredient in Byetta injection, which is currently available on the market for people with type II diabetes who are unable to achieve good glycemic control with common oral therapies. Exenatide once weekly is co-developed by Amylin, Eli Lilly and Alkermes.Following the news, shares of the three companies all shot up, with Alkermes shares up the most at ...

Last year, the Biotech industry as a whole achieved much better performance than the market. Both the NASDAQ Biotech Index and AMEX Biotech Index outperformed all three major market indices (Dow Jones Industrial Average, NASDAQ Composite and S&P 500) in a large margin. The major indices declined as much as 40%. While NASDAQ Biotech Index declined only 12.6%, and AMEX Biotech Index was down 17.7%.

However, when the recession enters into its third year, the Biotech industry is not doing better than the market, which has been evident by the indices' performances. As of April 9, 2009, AMEX Biotech Index declined 3%, and the broader NASDAQ Biotech Index was down 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies). Although the Dow and S&P 500 also declined a similar percentage, technology-laden NASDAQ actually has a gain of 4.8%, which is more comparable to the

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