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MannKind's Inhaled Insulin Verdict Delayed by FDA

MannKind (MNKD) logoPharmaceutical company MannKind (MNKD) shares have traded considerably higher this morning, gaining 9% shortly after the opening bell and trading in the upper $8 region. It appears that the rally was sparked by news that the U.S. Federal Drug Administration would not be able to complete a review of the company's inhaled insulin Afrezza by December 29.

The FDA added that it will need roughly four more weeks to complete the review. Back in July, the FDA accepted a resubmission on Afrezza and classified it a class 2 response.

Continue reading MannKind's Inhaled Insulin Verdict Delayed by FDA

GlaxoSmithKline Rises on FDA's Avandia Decision

GSK logoGlaxoSmithKline (GSK - option chain) shares are rising today after the FDA Advisory Committee voted in favor of keeping GSK's diabetes drug Avandia on the market, despite concerns that the drug could increase the risk of cardiovascular disease. If you think that the stock won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on GSK.

GSK opened this morning at $37.06. So far today the stock has hit a low of $36.77 and a high of $37.16. As of 12:10, GSK is trading at $37.06 up 0.71 (2.0%). The chart for GSK looks neutral and S&P gives GSK a neutral 3 STARS (out of 5) hold ranking.

Continue reading GlaxoSmithKline Rises on FDA's Avandia Decision

Eli Lilly to restructure, bet on drug portfolio

Pharmaceutical company Eli Lilly & Co. (NYSE: LLY) is planning to cut 5,500 jobs over the next few years and reorganize into five business units. The company is looking to reduce costs and accelerate how long it takes new drugs to get to market, especially as its top performers see their patents expire. This translates to a workforce reduction of close to 14% – to 35,000. This measure doesn't include new positions in emerging markets with high potential and Japan.

The company hopes to cut as much as possible through attrition and retirements – and it would not indicate how many other positions would have to be cut.

Eli Lilly's goal is to slash its annual cost by $1 billion during this restructuring. The new business units will be: cancer, diabetes, established markets, emerging markets and Elanco, which is its animal health business. This is a change from the existing functional model, which separates U.S. and global marketing for each drug in the company's portfolio. Through the new structure, Lilly says, drug development and marketing will be tied more closely.

Continue reading Eli Lilly to restructure, bet on drug portfolio

Government diabetes study hits a speed bump

pill bottleThe National Institutes for Health has announced the partial suspension of a diabetes treatment study which was focusing on aggressive measures to reduce blood sugar levels. An article in The Wall Street Journal indicates that the aggressive strategy being used apparently resulted in a small increase in the number of patient deaths as compared to a moderate treatment approach being used on other patients who were involved in the study. The increase was merely three deaths per 1000 patients, yet researchers are unable to correlate the exact reasons for the increase in deaths and therefore the more aggressive portion of the testing has been terminated.

The study did not focus on specific treatments. Rather, researchers were attempting to determine the importance of differing treatment strategies. John Buse, president for medicine and science at the American Diabetes Association stated, "We were basically trying to see if we should have a full-court press on blood sugar or just try to do a reasonable job." The study, which is named Accord, involves providing diabetic patients with various drugs in an effort to reduce blood sugar levels and is also seeking to isolate particularly beneficial bio-markers for monitoring diabetic patient health.

Continue reading Government diabetes study hits a speed bump

Novartis (NVS) sees progress on diabetes drug

NVS logoNovartis AG (NYSE: NVS) shares are trading higher today after the company reported progress with Galvus, a drug the company is developing to treat type-2 diabetes. Shares are up slightly on this news even as another drug being developed by NVS and Momenta (NASDAQ: MNTA) was denied approval by the FDA. If you think that the company won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on NVS.

After hitting a one-year high of $61.6 last November, the stock hit a one-year low of $51.19 in August. NVS opened this morning at $53.52. So far today the stock has hit a low of $53.07 and a high of $53.61. As of 11:20, NVS is trading at $53.10, up $0.17 (0.3%). The chart for NVS looks bearish and steady, while S&P gives the stock a neutral 3 STARS (out of 5) hold rating.

Continue reading Novartis (NVS) sees progress on diabetes drug

Top 25 Stocks for the NEXT 25 years: DexCom (DXCM) update

Back on June 13, I wrote about DexCom Corp. (NASDAQ: DXCM) as one of the top 25 stocks for the NEXT 25 years. The stock was just under $7 with a market capitalization of $180 million. Today the stock is at $9.61 with a market cap of $280 million. The shares have performed well these past two and half months, but the best is certainly yet to come.

DexCom is targeting the massive diabetic market of five million Americans who suffer from this disease. These patients need to monitor their blood glucose on a daily basis and treat it with injections of insulin.The methodology used by most patients is a painful pin-prick usually on a finger. The problem -- therefore the opportunity for DexCom -- is that the daily readings can be scattered and inconsistent. The readings depend on time of day and recent dietary intake. With DexCom, however, the reading is continuous and fluid during the course of a day, thus allowing the patient to self-administer insulin at the right moments. Plus, with DexCom, there is no painful pin-prick.

Continue reading Top 25 Stocks for the NEXT 25 years: DexCom (DXCM) update

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."

Top 25 stocks for the NEXT 25 years: DexCom

The NEXT company in my on-going series of the top 25 stocks for the NEXT 25 years is DexCom, Inc (NASDAQ: DXCM). This San Diego, California-based company has the opportunity to address the millions of people that suffer from diabetes. DexCom manufactures a continuous glucose monitoring system, which is extremely user-friendly and helps improve the diabetics' quality of life.

DexCom's business model is the classic razor-razor blade. DexCom sells a wireless glucose monitoring device, for about $800 per unit. Because of the wireless component, the monitor is completely mobile with the patient and can even be hooked to a belt like a cell phone. The company also sells the "implantable" disposable sensors that the patients slip-in just under the skin. Each sensor is good for up to 72 hours. The sensors come in a five-pack and sell for about $175 a pack.

Patients no longer have to endure the painful finger prick to draw a minor amount of blood to detect their glucose level. Also, with the monitor and sensors, the readings are far more accurate and continuous so the patient can administer the necessary insulin at the precise time versus a bit of a guessing game.

Continue reading Top 25 stocks for the NEXT 25 years: DexCom

Splenda vs. Equal: Battle of the Brands

This post is part of our Battle of the Brands feature. Let us know which brand you prefer, and check out other Battle of the Brands posts.

I never paid that much attention to the pink and yellow and blue packets on the table when my wife and I go out for breakfast a couple of times a week. I'm not a consumer of artificial sweeteners, so when I learned that we wanted to add one more match-up to our Battle of the Brands feature, this one focusing on Splenda and Equal, and that it was going to be up to me pull it together, I thought: Oh boy, what am I going to have to say about that?

But I've never been one to pass up an opportunity to learn something new. I began with what I did know, which wasn't much: the makers of Splenda and Equal were in the news recently -- something about misleading advertising and sour grapes. Besides, weren't these yellow and blue packets really second banana to the ubiquitous Sweet'N Low pink packets? Shows how much I know: turns out Sweet'N Low's virtual monopoly on the artificial sweetener market ended back in the 1980s, when Equal took the lead. Since Splenda was introduced in 1999, however, it has exploded, with sales of more than $200 million in 2006, or about 60% of the U.S. artificial sweetener market. Equal's sales have dropped about $30 million in that time, while sales of sugar have dropped $85 million. No wonder sugar producers and the makers of Equal have gone after the makers of Splenda in court.

For someone who doesn't know his blue packet from his yellow packet, what really is the difference between them?

Continue reading Splenda vs. Equal: Battle of the Brands

Pepsi funds HFCS study, says it, sugar are equal: but still might switch to sugar?

When I was writing about Jones Soda Co. (NASDAQ:JSDA) and their announced switch to sugar instead of high fructose corn syrup as sweetener, I didn't read all the way to the end of the Wall Street Journal [subscription required] story. I should have, though, as it's really the big news.

PepsiCo, Inc. (NYSE:PEP) funded a study on high fructose corn syrup, which indicates that sugar and high fructose corn syrup have nearly the same effect on the body, and found no difference in the way the two substances contribute to weight gain. (The study is being written up for submission to a journal by researchers at UC Davis.) Pepsi is promoting this study heavily and said in response to Jones' move, "To say cane sugar is healthier than HFCS just isn't true. Marketing a myth for a competitive advantage is irresponsible and short-sighted."

But. But! Pepsi is working on some versions of its most popular sodas, including Sierra Mist and Pepsi itself, that contain sugar instead of high fructose corn syrup -- along with the removal of some preservatives and artificial colors. This news, reported by Beverage Digest magazine, seems at cross purposes with Pepsi's spokesman's claim.

If Pepsi is so sure high fructose corn syrup is safe -- and so interested in making sure consumers believe it -- why would it even dream of converting? Something tells me we haven't heard the end of Pepsi's evaluation of HFCS.

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Last updated: February 13, 2012: 06:40 PM

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