New Targets, Dual Agonists Increase Possibilities for Treating Diabetes

Action of GLP-1 and DPP-4 inhibitors.Image via Wikipedia Fritz French, Chief Executive Officer, Marcadia Biotech, Carmel, Ind.
Drug Discovery & Development - August 16, 2010

Diabetes is a common chronic disease affecting an estimated 285 million adults worldwide. This number will continue to grow as the population ages and becomes more obese—both risk factors for type 2 diabetes. The diabetes treatment market generated over $25 billion in 2009 and the number of patients is continuously rising.


New Anti-Clotting Drugs May Have Edge Over Top-Selling Plavix

A box of PlavixImage via Wikipedia Health Care, Bristol-Myers Squibb, Sanofi Aventis, Eli Lilly, Astrazeneca

Several recent studies of drugs used to treat and prevent strokes appear to favor AstraZeneca's (AZN) Brilinta and Eli-Lilly's (LLY) Effient over Plavix. Plavix, co-marketed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY), is the second best-selling drug in the world.

Genzyme Rejects Sanofi Takeover Bid

Sanofi-AventisImage via Wikipedia Latest on Genzyme's Merger with Sanofi-Aventis
By Val Brickates Kennedy and Polya Lesova, MarketWatch

BOSTON (MarketWatch) -- Following weeks of speculation, beleaguered biotech leader Genzyme Corp. on Monday formally rejected a $18.5 billion takeover offer from French pharmaceutical firm Sanofi-Aventis, asserting that the bid substantially undervalues the company.

U.S. stock indexes falter as Wall Street Frets About Economy

Image representing Intel as depicted in CrunchBaseImage via CrunchBase Here is today's story from Marketwatch which pretty much sums up the economy as a whole right now. Most BioPharma Stocks are down for today. When they do well they tend to do really well but just not today. Monday showed investor's fear as job data comes out Friday. No Jobs = No Recovery

Market Snapshot for Monday August 30th, 2010.


Friday's Top Performing Healthcare Stocks

NASDAQ in Times Square, New York City, USA.Image via Wikipedia Here are today's top performing Biotech, Pharmaceutical and Medical Stocks. The stock market did well today but these stocks took off today. Most have been beaten up pretty bad with the economic downturn this past year and lack of credit lending for biotech businesses by the big banks.

Top Performing Medical Stocks


Radient Pharmaceuticals Emerging Cancer Screening Technology

AMEXImage via Wikipedia Radient Pharmaceuticals (AMEX: RPC) is having one impressive day. Today it announced target market details for the commercialization of its Onko-Sure in vitro diagnostic cancer test.

It received approval FDA approval 24 months ago and has been validating test kits for oncologists, gastroenterologists, and lab directors for use. The company is now in position for marketing and commercializing Onko-Sure technology.

Alexza Pharmaceuticals Oct 11th FDA Decision for Staccato Technology

NicotineImage via Wikipedia Time to start buying more shares of Alexza Pharmaceuticals (ALXA). Another promising run-up play for October is Alexza Pharmaceuticals and its lead candidate AZ-004, which is an inhalation product candidate for the rapid treatment of agitation in patients with schizophrenia or bi-polar disorder. It has a PDUFA(FDA Decision) date of October 11th, 2010.


Red Hot Somaxon gets even hotter with Proctor & Gamble deal

Logo for Procter & Gamble. Source of the logo.Image via Wikipedia Red Hot Somaxon Pharmaceuticals is up heavily in trading today. The stock has done extremely well this year and will probably do even better after this deal was made today. Somaxon Pharmaceuticals (SOMX) is trading at 4.34 up 0.97 a 28.78% gain. Earlier today it reached a high of 5.43 before a strong selloff. The stock has been in a heavy downslide trend following it's March FDA approval. Look for things to get a little better after today with increased sales for insomnia medication Silenor

Chasing Influenza: History of the Flu

"Walter Reed Hospital Flu Ward". Pho...Image via Wikipedia Here is a really informative article on the History of the Flu by Quintiles White Papers. PDF format is the link below. It's Flu season again. Companies are ramping up their stockpiles of Flu Vaccines and you can get the flu shot at Walgreens and CVS these days.

I personally don't believe all the hype and practice safe "People handling" when I go out and use hand sanitizers every chance I get. One day a real Pandemic will emerge like the 1918 Flu and there is not much we can do about it. Novartis, Glaxo SmithKline, Baxter, and MedImmune are your top Flu stocks.

Chasing Influenza

Two dangerous Myths About the Economic Stimulus Package

PHILADELPHIA - MAY 8:  Economic stimulus check...Image by Getty Images via @daylife Here's a good read about the stimulus.

By Rex Nutting, MarketWatch

Commentary: We'd be in a much deeper hole without government's help

WASHINGTON (MarketWatch) -- We are in danger of making a dangerous U-turn on economic policy because our judgment is clouded by common misconceptions about the government's stimulus programs.

In some cases, Republican leaders have deliberately distorted some of these programs to spread doubts about the Democrats' policies. In other cases, urban myths have sprouted up without anyone deliberately fertilizing them.

Here are two of the worst misconceptions.

Myth 1: TARP and the stimulus are the same thing


Jazz Pharma rejected for Fibramyalgia Drug by FDA vote 20-2

4-hydroxybutanoic-acidImage via Wikipedia Okay I'm not going to write an article about woulda coulda shoulda. But Jazz was shot down today heavily by the FDA by a vote of 20-No 2 Yes. Mostly due to concerns over abuse of the JZP-6 sodium oxybate drug which is highly similar to GHB. GHB was banned altogether by the FDA in 1990 and is viewed to have no medical benefits in the US.


Thursday's Top Performing Biotech and Pharmaceutical Stocks

Dismal day again on Wall Street as Unemployment Data showed 500,000 new jobless claims and increased fears of a double dip recession are mounting. Also, a fear in tax hikes with the end of Bush Tax cuts ending in 135 days. The economy is very nervous and jittery. Luckily BioPharma plays can go up regardless of all of this negative news. Unfortunately, not as much as they used to because of nervous investors who sell, sell, sell before FDA decisions. I understand though. I wouldn't want to lose a lot of money because of a negative recommendation either. Sometimes you have to go with your gut on some things and let it ride.

Big news with Intel buying McAfee for a premium as McAfee's stock rose 57%. But the BioPharma market painted a different picture with most stocks down for the day between 1-2% overall. Tomorrow is a big day for Jazz Pharma with FDA recommendation panel for their Fibramyalgia medication. I expect approval and a strong day for Jazz. If not then it will go down heavily. But I just don't see that happening as the medication is already approved for Necrolepsy. There is a huge safety concern for the medication as outlined in yesterday's Wall St. Journal article FDA Raises Concerns About Fibromyalgia Drug. This being said I am letting it ride tomorrow and if it goes up it goes up, if it goes down it goes down. We will see.

Investment plays I currently like are BioElectronics BIEL, Amarin AMRN, and Exact Sciences EXAS. Jiangbo Pharmaceuticals JGBO has been gaining strength lately with a Strong Buy rating, Endo Pharmaceuticals ENDO, and KV Pharmaceuticals KVA.

Thursday's Top Performing Pharmaceuticals


Top Performing Biotech and Pharmaceuticals for Wednesday August 18th

Image representing Jazz Pharmaceuticals as dep...Image via CrunchBase Today was a good day for recommendations and Friday gets even better with Jazz Pharmaceuticals presenting August 20th to the FDA for their Fibramyalgia medication JZP-6 sodium oxybate. Jazz had huge gains this morning as the FDA handed out their review of the clinical trial. Jazz shot up around the 11.90 mark and has been so oversold that right now it's pushing 10.49 in afterhours trading. It has been All Over The Map Today. Speaking of all over the map, BSD Medical exploded today with their medical device approval from the FDA. Just exploded all over the map. What a day.

Jazz was disappointing in the fact that everyone sold. Everyone is scared to death to leave it in the market for the FDA decision. Shoot the dice and let it roll sometimes. But we know where most people stand on this one. I'm taking my profits and waiting for tomorrow where I kick myself for selling. This one's a no-brainer in my department for Approval tomorrow.

Top Performing Biotech Stocks for Wednesday August 18th

Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

Image representing Alexa as depicted in CrunchBaseImage via CrunchBase Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

I have actually changed positions on this stock and do not think it will be approved based on a conservative FDA panel under the Obama Administration.  I might change that opinion but we will have to see on This Weeks FDA panel meeting.
About the author: Sheff Station Sheff is a trader and investor of big board, small cap, and biotech stocks.

Avanir’s STAR trial gives clarity to the FDA for Oct 30th Decision.

Image representing Seeking Alpha as depicted i...

Repost of Seeking Alpha Article on AVNR. Avanir has an upcoming FDA recommendation decision date on Oct. 30. We will see if they stick with that actual date for a Spooky Halloween Trade.

By: Sheff Station

Avanir’s STAR trial gives clarity to the FDA for Oct 30th Decision.

Jul 30, 2010 2:14 AM | about stocks: AVNR, ALXA, ARNA

In early 2006 AVNR filed a drug application for Zenvia. They had filed a submission for Zenvia with the 30/30 dose combination. Two Phase III studies demonstrated safety & efficacy of Zenvia in PBA as well as 10 clinical trials. Priority review was received from the FDA as they acknowledged it’s a disorder with a high unmet medical need. In late 2006 AVNR received an approvable letter from the FDA.

FDA staff: Jazz drug works, risk plan an issue

Image representing Jazz Pharmaceuticals as dep...

By Lisa Richwine

WASHINGTON | Wed Aug 18, 2010 11:23am EDT

(Reuters) - U.S. drug reviewers said a Jazz Pharmaceuticals Inc medicine helped patients with the pain disorder fibromyalgia, sending shares up 14 percent Wednesday on hopes an approval could sharply boost the company's sales.

Food and Drug Administration staff said the drug, sodium oxybate or JZP-6, was effective. But they also questioned if the company's proposed safeguards would adequately prevent improper use. The medicine contains an ingredient notoriously abused as a "date rape" drug.

Jazz Up Today Before Tomorrow's FDA Hearing, While Xoma Has Reverse Split

Logo of the U.S. Food and Drug Administration ...Image via Wikipedia By Val Brickates Kennedy, MarketWatch

BOSTON (MarketWatch) -- Shares of biotech group Xoma Ltd. spiked over 1,000% at market open Wednesday as the company conducted a 1-for-15 reverse stock split in order to boost its stock price to meet Nasdaq compliance rules.

For the next 20 trading sessions, Xoma will trade under the stock symbol XOMAD to reflect the split; after that time, the stock will revert back to its previous trading symbol of XOMA.

Xoma also announced that it has sold its royalty rights to the antibody treatment Cimzia for $4 million to an undisclosed buyer. The product, which is approved in the U.S. for the treatment of Crohn's disease and rheumatoid arthritis, is marketed by UCB S.A.

Shares of Xoma(XOMAD 3.68, -0.54, -12.82%), trading under its new symbol, were down 11% at $3.77.

Jazz Pharmaceuticals shares (JAZZ 11.37, +1.12, +10.93%) rallied after documents released by the U.S. Food and Drug Administration revealed that agency reviewers believe its drug candidate JZP-6 is effective in treating the pain condition fibromyalgia. The documents, however, also showed that they still have certain safety concerns about the medication.

BSD Medical receives FDA clearance for MTX-180

Image representing Business Wire as depicted i...Image via CrunchBase SALT LAKE CITY, Aug 18, 2010 (BUSINESS WIRE) -- BSD Medical Corporation /quotes/comstock/15*!bsdm/quotes/nls/bsdm (BSDM 1.82, +0.69, +61.06%) (Company or BSD) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market its MicroThermX Microwave Ablation System (MTX-180) for ablation of soft tissue. Clearance from the FDA of BSD's 510(k) Premarket Notification submission authorizes the commercial sale of the MTX-180 in the United States. The MTX-180 was designed to provide a higher power, optimized system targeted to the growing therapeutic interventional and surgical oncology market.

Warning, bear market 2010 as To Eat, Pray, Love

Cover of "Eat, Pray, Love: One Woman's Se...Cover via Amazon I couldn't have said it better myself right now. Except now they are saying Treasury Boom is about to burst. But this ties in Julie Roberts' movie Eat, Pray, Love to stock investing in a lighthearted, direct to the point manner. Warning more Doom and Gloom. I'm still trying to find the right plays in BioPharma myself these days.

Warning, bear market 2010: 11 'sells.' Only 6 'buys'
New Normal: Bankrupt nation. Deflation. Zeros. Junk. No jobs. Depression


Biotech and Pharmaceuticals Top Performers Tuesday's Edition

Big Day today in the market as Wal-Mart, Kraft and Home Depot pushed earnings up today. Both the DOW and NASDAQ were up 1% today, but this does little to mend the broken market returns of last week just yet.

My big surprise is the Biotech and Pharmaceuticals that don't rise much before big FDA decisions anymore. They seem to crash with the market and get oversold quickly before the big decisions. Jazz Pharma has been down heavily the past two sessions and others as of late have been slightly mixed before big FDA Decisions are looming.

Nonetheless here are today's Top Performers. Beat The Street on these stocks today. I like a lot of these upswing trades made today for Long-Term Growth.

Top Biotech Performers Tuesday


The Street's Equity Top Rated Stocks: Life Sciences Tools & Services

Image representing TheStreet as depicted in Cr...Image via CrunchBase
Every day TheStreet Ratings produces a list of the top rated stocks. Every day we will publish several lists to provide you with some stock buying (or selling) ideas.

Equity Top: Life Sciences Tools & Services
Symbol Equity Rating

Hindenburg Omen Spells Doom. Great What's Next.

I cant make this stuff up. People just lost their shirts last week and all we hear is doom and gloom. Not so sure how this will pan out. The doom and gloom people are doing well trading on investors fears in the market right now. Where's the optimism these days? When will the recover start?

'Hindenburg Omen' Flashes Technical Gauge and Its Creator Sense Stock Gloom; 'Good Conspiracy Theories'?

The Omen's Criteria
All criteria must be met for a confirmed occurrence.

-The daily number of new NYSE 52-week highs and the daily number of new 52-week lows must both be greater than 2.5% of the total issues traded that day.

-The smaller of the 52-week highs and lows must be greater than or equal to 79 (or 2.5% of 3,168 issues).

-The NYSE's 10-week moving average must be rising.

-The McClellan Oscillator, a measure of market fluctuations, must be negative.

-New 52-week highs can't be more than twice the new 52-week lows. (However, it is acceptable for the new 52-week lows to be more than double the 52-week highs.) 

'Hindenburg Omen'


Forget about Friday the 13th. Many on Wall Street took to whispering about an even scarier phenomenon—the "Hindenburg Omen."


Last Week's Top Performers for the BioPharma Market


I was almost too distaught to write an article after last Friday but decided we have to move on and look for gems in the rough. So there were a few Gems but a lot of Glooms. BioPharma Indexes are down almost 5 percent based on last weeks momentum downslide in the overall market. For just a taste of how bad it was ProShares UltraShort S&;P500 (ETF) (NYSE:SDS) was up 7.4% on shorting the market.

But lets take a look at some Top Performances last week.


Top BioPharma Performers Thursday August 12th

Konzernzentrale von GlaxoSmithKline in LondonImage via Wikipedia

Top Biotech Performers for today (aside from the MakeMyTrip IPO up 70% for the Indian IPO) Prices reflect a 2PM stock trading time. Columbia Labs and Vivus have since gone up.
Top Performing Biotech


Biovail, Valeant Pharmaceuticals, GSK gain FDA recommendation for Epilepsy drug Potiga

Biovail logoImage via Wikipedia

Today saw some good news from the FDA as they recommended the joint venture drug, Potiga, by Valeant Pharmaceuticals and Glaxo SmithKline. Valeant is in merger acquisitions with Biovail that should be completed by the year's end.

U.S. Food and Drug Administration advisory committee voted unanimously 11-0 that clinical studies had provided substantial evidence on the safety and effectiveness of ezogabine to treat epilepsy. The Prescription Drug User Fee Act goal date for the FDA to complete its review of the drug’s application is August 30. The drug will be aimed at patients whose other epilepsy medications failed.

Market Thoughts for Wednesday August 11th

The market took a hammering today but some stocks actually performed or are now great buys. The DOW Industrial average DIJA is closing sharply lower today at 10379. That's a 265 drop from yesterdays close of 10644 and a 2.49% decline as Global Fear strikes domestic and foreign markets.

Today's top performers in BioPharma for August 11th.



BioPharma List for Wednesday August 11th

Stocks that I will be following for the near future. Yesterday's market was down heavy due to the FED's recommendation but we will see how the market recovers Wednesday. The FED acknowledged the economy needs help and was cashing in mortgage securities into long-term treasury notes.

Here are stocks I am currently following for Wednesday and interested by near future events.

1. BSD Medical BSDM

Three Extreme FDA Medical Device / Diagnostic Trades
by: Mike Havrilla June 03, 2010


BioPharma Stock Watch Tuesday August 10th

Longton stocks near the library.Image via Wikipedia Stocks I am following for Tuesday.

Monday's BioPharma List for August 9th

In inflation adjusted terms, the US stock mark...

Top Pharmaceuticals for Monday August 9th

1. K-V Pharmaceuticals This one is slightly unpredictable (NYSE:KV.A) at 1.46 up +0.17 a 13.17% gain after having a 20.6% increase last week.

2. Roche Holdings RHHBF; F denotes a foreign stock trading on Nasdaq this quote is from last week as this stock trades based on a foreign market. Last week up 10.50 at 142.00 a 10.50% gain. The stock has been down as of late but I predict that things could change in the near future for the better.

Their US Based stock RHHBY was flat today. (RHHBY)

Top Japanese BioPharma on the Move

Tamiflu 75mg JP 1Image via Wikipedia Top Japanese BioPharma on the Move.


Top BioPharma Pipeline Plays August 2010

Image representing Celgene as depicted in Crun...Image via CrunchBase Stocks currently on my Watchlist for top BioPharma plays in the near future.

1. Valeant Pharmaceuticals (NYSE:VRX)

Biotechnology Research Report on Valeant's Potiga

On August 11, 2010, we expect the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee to review the marketing application of Valeant Pharmaceuticals International’s (VRX) Potiga (formerly known as Retigabine), designed for the treatment of partial-onset seizures in epilepsy patients who have become refractory (failing to show response to prior therapy) to anti-epilepsy drugs (AEDs).

Nanoshell particles

Macrophages intake the nanoshells into the tum...Image via Wikipedia Nanoparticle Cancer Treatments 100% Eradication
 by James Rickman

Nanoshell therapy is comprised of three components:
- an off-the-shelf near infrared laser source
- an off-the-shelf interstitial fiber optic probe delivers the laser energy to a site near or inside the tumor
- the investigational nanoshell particles, a near-infrared absorbing, inert material designed to absorb and convert the laser energy into heat.

Pharma's R&D Focus Shifting to Stem Cells

Image representing Cellular Dynamics Internati...

Another good article on Pharmaceutical companies unleashing the power of Stem Cells and increasing their research as a new wave of the future. I will comment further but it was a good read on things to come.

Pharma's R&D Focus Shifting to Stem Cells
Susan Aldridge, Ph.D.

Investors' Interest in These Cells Increases as Scientists Continue to Unleash Their Potential

Stem cells could replace and potentially improve upon at least some in vivo models in drug discovery and development. That was a key message from the “World Stem Cells and Regenerative Medicine Congress” held recently in London.

“There is a major focus now on stem cells in pharma R&D with the major investors showing an interest,” according to Ian Cotgreave, Ph.D., director of molecular toxicology and safety assessment at AstraZeneca. He noted that pharma’s current focus is on cardiomyocytes and hepatocytes, as well as on differentiation protocols and understanding phenotypic progression.

Nanotechnology Enables Precise Cancer Targeting

Image representing Abraxis BioScience as depic...

 I highly recommend reading about Nanoparticles in cancer targeting therapies. This was posted in GEN (Genetic Engineering and Biotechnology News) Many Stock Ideas here. I will post more on each company soon. This is the future of Biotechnology.

Nanotechnology Enables Precise Cancer Targeting
Patricia F. Dimond, Ph.D.

Second-generation nanotherapeutics to treat cancer have drawn attention and funding as companies move to improve the efficacy of these treatments and expand their applications. Generally in the size range of 1–100 nm, these drugs have emerged as novel antitumor agents because they have the potential to deliver high concentrations of drugs to cancer cells and cause less toxicity than systemically administered drugs.


Three Hot BioPharma Investment Plays: ARNA, JAZZ, and PRAN

Image representing Jazz Pharmaceuticals as dep...

 I have a few investment plays in the BioPharma field that I would like to share with everyone. These plays include Arena Pharmacueticals, Jazz Pharmaceuticals, and Prana Biotechnology. The first play is Arena Pharmaceuticals NASDAQ:ARNA. JP Morgan recently downgraded the stock Monday August 2 to Neutral, however Jim Cramer recommended the stock as a buy last Friday on his show MadMoney. Today's afterhours earnings estimate for Q2 was a better than expected loss and I see the stock rising heavily in the next month with the highly anticipated FDA panel review September 16th. ---I have since changed my outlook on all these stocks and actually recommend shorting them lately.