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A few more deaths brought to you by Eli Lilly and Amylin

Every time the FDA turns around, a few more people have died from the diabetes drug Byetta, a product developed and marketed by Eli Lilly (NYSE: LLY) and Amylin Pharmaceuticals (NASDAQ: AMLN). It has to make one wonder how the regulators spend their spare time.

According to The Wall Street Journal, the two companies "disclosed the deaths of four patients taking the diabetes drug Byetta that had been previously reported to regulators but not yet made public." The drug has already killed two people previously, at least.

Lilly and Amylin said they were a bit slow coming forward with the news because they wanted to "provide context" and "avoid confusion" in the future. That is double talk for the two companies not wanting to say anything at all. Dead is dead and there is no way of getting around that.

Why the FDA has allowed the drug to stay on the market is anyone's guess.

Douglas A. McIntyre is an editor at 247wallst.com.

Another FDA failure as Lilly drug causes more deaths

When should the FDA pull a drug off the market? When one person dies from side-effects? How about two or three?

Eli Lilly (NYSE: LLY) and Amylin Pharmaceuticals (NASDAQ: AMLN) produce a highly successful diabetes drug called Byetta. According to The Wall Street Journal, "The Food and Drug Administration on Monday said it has received six new reports of patients developing a dangerous form of pancreatitis while taking Byetta."

Two of the patients died.

The drug makers said that the poor results were very rare. The people who got sick probably view it a little differently.

There have been questions for some time about whether the FDA does an effective job of regulating drug companies. The problems with Byetta say that the answer is "no." A drug, which causes even one death, yet stays on the market speaks volumes about how the consumer's interests are cast aside.

Douglas A. McIntyre is an editor at 247wallst.com.

Biotech expert: A love affair with Amylin (AMLN)

"Right now I'm having a love affair with Amylin Pharmaceuticals Inc. (NASDAQ: AMLN); frankly, you should be in love with it, too." says Michael Shulman, editor of the industry-leading ChangeWave Biotech Investor.

The advisor notes, "Not only is it up a whopping 169%+ since I put it on the Buy List, it's also a hidden-value play -- more so than at any time in the past year. Simply put, Amylin is a great pick for patient investors."

Shulman continues, "Amylin no longer appears sexy or hot to some investors. It has a market cap north of $5 billion and its two newest drugs have been on the market for a couple of years, so the story on the stock appears to be over in terms of upside potential, right?

"Wrong," he exclaims. "Amylin is going to benefit in the coming months from a string of good news, beginning with the strong earnings it announced two weeks ago. The diabetes marketplace is exploding and Amylin is 'the' leading diabetes company."

Continue reading Biotech expert: A love affair with Amylin (AMLN)

Novo Nordisk drug data a 'positive surprise'

A press release [PDF] out this morning confirmed positive Phase III results of Novo Nordisk's (NYSE: NVO) potential blockbuster drug, Liraglutide, which is an analogue of the naturally-occurring hormone GLP-1 in development by Novo for the treatment of type 2 diabetes. The clinical results of the first of five late-stage studies showed that Liraglutide provided significantly better glucose control and led to significantly more weight loss than patients who used Sanofi-Aventis SA's (NYSE: SNY) Lantus.

Novo CEO Lars Rebien Sorensen said the company is looking to apply for regulatory approval of the drug in the U.S. and Europe in the middle of next year, and hopes to receive approval by mid-2009.

This data is excellent news for Novo, who has been trying to gain market share against competitors for some time in the attractive U.S. diabetes market. Unfortunately, the data is also a negative for rivals Amylin Pharmaceuticals Inc (NASDAQ: AMLN), Eli Lilly and Company (NYSE: LLY) and Pfizer Inc (NYSE: PFE), who all have diabetes drugs on the market - Byetta and the inhalable insulin Exubera, respectively.

Shares of Novo were up nearly 4.5% this morning on the Liraglutide data, which some analysts called "a positive surprise."

Market highlights for next week

Here is a look ahead to next week's three day trading week:

Monday January 1
  • Markets closed for New Year's Day holiday
  • PDUFA date for Amylin Pharmaceutical's (NASDAQ: AMLN) Byetta
Tuesday January 2
  • Markets closed in observance of President Ford's death
Wednesday January 3
  • Earnings conference calls for AngioDynamics (NASDAQ: ANGO), Landec Corporation (NASDAQ: LNDC) and the Topps Company (NASDAQ: TOPP)
  • Sales conference call for American Eagle Outfitters (NASDAQ: AEOS)
Thursday January 4
  • Earnings conference calls for Arrow International (NASDAQ: ARRO), Monsanto Company (NYSE: MON) and Sonic Corporation (NASDAQ: SONC)
  • Sales conference calls for Abercrombie & Fitch (NYSE: ANF), AnnTaylor Stores (NYSE: ANN) and bebe stores (NASDAQ: BEBE)
Friday January 5
  • Shareholder meeting for Serono S.A. (NYSE: SRA)

Symbol Lookup
IndexesChangePrice
DJIA+44.2910,291.26
NASDAQ+15.822,166.90
S&P 500+5.501,098.51

Last updated: November 11, 2009: 05:27 PM

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