blah blah blah blah

I posted this because you DON'T have to read it. It's damage control. We have This but That isn't getting approval. I love the how the PR people put spins on data. What do we believe. THAT is why i'm here.



Health care giant Johnson & Johnson likely will discuss its pipeline, recent drug approvals and several important deals when it reports its third-quarter results before the stock market opens Tuesday.

WHAT TO WATCH FOR: Executives will tout progress addressing problems behind an embarrassing string of product recalls that's hurt J&J's revenue and image, and their plans to get some of J&J's many recalled consumer health products back on the market. Last month, J&J said it resumed shipping Tylenol Cold & Flu Severe caplets, just ahead of cold season. SHOCKING!!!!! $$$$$$

Since September 2009, the company has issued more than 25 recalls, including a few prescription medicines, contact lenses and defective hip replacements, for reasons ranging from improper potency to glass or metal shards in liquid medicines. The latest recall, on Sept. 23, affected 200,000 syringes of anemia drug Eprex sold outside the U.S., because of inconsistent potency.

The company may OR NOT! give updates on several pending deals.

Its biggest acquisition ever -- $21.3 billion to buy U.S.-Swiss medical device maker Synthes Inc. and boost its position in the growing market for orthopedic surgery products -- is still expected to close in the first half of 2012.

In late September, J&J paid $175 million to buy out Merck & Co.'s half interest in their 22-year-old joint venture, Johnson & Johnson-Merck Consumer Pharmaceuticals Co., which sells over-the-counter versions of former prescription drugs, including stomach medicines Pepcid, Mylanta and Mylicon. J&J will rename the business McNeil Consumer Pharmaceuticals Co.

A $345 million agreement to sell dermatology businesses that make products including wrinkle and acne cream Retin-A to Canada's Valeant Pharmaceuticals International Inc. is still expected to close by year-end, although the Federal Trade Commission has asked for more information. And J&J's Ethicon Endo-Surgery business agreed in late September to buy privately held SterilMed Inc. It repairs and sterilizes used medical devices such as those made by J&J's biggest division, medical devices and diagnostics.

During the third quarter, the maker of baby shampoo, biologic medicines and birth control pills saw several drugs win new approvals, including extended-release Nucynta, a narcotic pill for moderate-to-severe chronic pain. One product was rejected.

Last month, a panel of advisers to the Food and Drug Administration recommended the agency approve use of anticlotting drug Xarelto for preventing stroke in patients with a common irregular heart rhythm called atrial fibrillation. The FDA is expected to make a decision in the first week of November.

The drug was approved here in July for a much smaller patient group, those getting knee and hip replacement surgery. J&J and partner Bayer Healthcare of Germany plan by year-end to apply in the U.S. and Europe for approval to sell it for patients with acute coronary syndrome, in which blood supply to the heart is blocked, causing chest pain or a heart attack.

Regulators in the European Union in September approved sales of J&J's Zytiga, a new pill for treating advanced prostate cancer after chemotherapy. It was approved in the U.S. in April, so initial sales here likely will be discussed.

Also in September, the EU approved sales of Incivo, one of two new drugs that greatly improve cure rates for tough-to-treat hepatitis C. J&J has rights to sell it in most countries outside North America. Two partners have the rights in North America, where it selling under the name Incivek, and some Asian countries.

J&J's blockbuster immune disorder drug Remicade, already approved for 15 uses, last month won another approval, for treating children with ulcerative colitis. But in July, U.S. regulators rejected a new use for successor drug Simponi, for slowing structural damage in rheumatoid arthritis patients. The company is to meet with FDA officials in November to discuss how to proceed.

Analysts may ask about a tentative settlement reached in August to settle a criminal charge in a multiyear government investigation over marketing psychiatric drug Risperdal for unapproved uses. A company spokeswoman could not say when the settlement will be finalized or disclose the financial penalty. Meanwhile, cases involving improper marketing or overcharging state governments continue in 11 states, but a case was dismissed in West Virginia.

Last week, J&J agreed to pay $85 million to the Department of Justice to resolve allegations it improperly marketed heart failure drug Natrecor for chronic use, instead of just for patients with acute heart failure.

85 Large in fines. Maybe that is the problem with the system. No new drugs from biotech because of marketing? Where is the SCIENCE??????

Q3 Earnings

The FoB team is actively reviewing numbers and preparing a detailed list of clinical trial data that will impact the Q4-beyond prices of what we think are potential blockbusters.
I have enlisted the help of Tracey and "Big Action" to help in the upcoming onslaught of earnings with my experience with clinical trial data interpretation. Should be a fun Q4.

I think the views of BioTech companies are skewed...LOOK at CELG

I think CELG is on the forefront of charitable sponsorship. Beside the cost of basic research and finding the cash for events such as this and ones sponsored by CELG in San Diego, New Jersey and San Francisco, this is very commendable.

The 22nd Annual Cox Classic, presented by The Hibbert Group along with lead sponsor Celgene, will take place on Monday, at the New Jersey National Golf Club, in Bernards.

Since 1989, the event presented by the Steven A. Cox Foundation has raised some $6.4 million to benefit children’s charities and other causes, while attracting a wide range of corporate sponsors and participants from the tri-state area.

This year’s Classic will support the educational outreach efforts of LIFE (LPGA Players in the Fight to Eradicate Breast Cancer), led by Val Skinner in support of the BioCONECT initiative with the Cancer Institute of New Jersey. In addition, the Classic benefits the St. Jude Children’s Research Hospital,

The final beneficiary of the 22nd Annual is Rutgers, The State University of New Jersey, which — through its Department of Chemistry and Chemical Biology — has established the “Steven A. Cox Scholarship for Cancer Research at Rutgers University.”

In addition to the event’s top sponsors, The Hibbert Group, New Jersey National Golf Club and Celgene, the 22nd Annual Cox Charity Classic is backed by many corporate sponsors, including Asurion and Haddad & Partners, AT&T, Atlantic City Electric, Ferriero Engineering, Maritz, Met Life and OSB Co.

Led by 2011 U.S. Solheim Cup Captain, Rosie Jones, the tournament will be headlined by the ladies of the LPGA, who will be providing tips at the practice range prior to the tournament, and participating in several on-course skills contests. The 2011 event features an 18-hole golf tournament followed by a cocktail reception, dinner, and awards ceremony. Highlighting the evening festivities is a post-golf reception that brings participants and dignitaries together to socialize, while celebrating the event’s great charitable endeavors. Participants will have the opportunity to win an assortment of gifts and prizes in a silent auction offering a breadth of sports memorabilia.

“The Steven A. Cox Foundation is extremely proud to host our 22nd consecutive Cox Classic and support three such outstanding beneficiaries,” said Mike Marion, chairman of the Steven A. Cox Foundation. “This event is dedicated to honoring and celebrating the life of Steven Cox, and preserving his legacy through philanthropic initiatives supporting critical women’s and children’s causes.” Cox lost his battle to cancer in 1991 at the age of 32.

While the event is sold out for 2011, companies interested in any of the 11 sponsorship categories available in the tournament, can visit www.coxcharityclassic.com.

Just Back from HI Timeout

For the last 6 days, I had to distance myself from the bloodbath of the biotech market. I took the staff (of two) from the Fundamentals website (FoBio) to Hawaii for some much needed relaxation and to brainstorm for upcoming Q4 results and Q1 expectations/results from clinical trials. There was some debauchery and some memories about a charter boat?? that are not so clear yet. And I can't find that credit card. Oh, well. Good times.

So, Mahalo for you that still check this site out. I'm back on the mainland 9-10 and will get back to work immediately.

P.S.--I wrote this sitting on a beach, with my staff in bikinis, sitting on a beach in Maui. Life is good.

Labor Day...

Will be on holiday for the next few days.

Upcoming reports:

3D cancer cell culture models
Abraxane and Nab technology
2011 AACR meeting update from Orlando (late)
market movers and clinical trial updates

clinical trial updates and interpretations. Drugs in development and the potential for investments.

Have a good holiday weekend All.

3D Spheriod Cancer Cell Culture

The hot thing now in biotech/pharma discovery research is trying to recreate the tumor micro-environment.

Everyone has/knows matrigel. It's the "3D" culture vessel of choice; which is basically a cocktail of growth factors and basement membrane adherent factors that promote cell growth in non adherent conditions and preventing apoptosis.

We want to study how the tumor grows and how we can get a targeted drug inside that tumor. In vitro, we use siRNA technology to "knock down" the protein e.g., to prevent the protein's function to study it's biology in it's absence. In 3D cell culture this allows us to recreate mini microenvironments to test new drugs.

A 3D cell culture spheroid using matrigel.

3-D tumor biology: A new stance on in vitro drug design?

A taste to see what's coming. Is the wave of the future in drug design using 3D cell culture models? Does this really mimic the tumor microenvironment?
this is a spheroid tumor growing in a 3D cultue system.
Many questions...can a drug get inside? What is the micro-environment? pH? We can answer these questions. stay tuned!

BioTech hot most watched stocks as of 8-26-2011

Here is a list of the most watched stocks today

The 15 Most-Watched Biotech Stock

People watch stocks for different reasons -- they're waiting for a dip in price, watching for a specific catalyst, gathering all the news and information that might affect stocks they already own, or considering a sell. Regardless of their motivation, we can better understand market sentiment by seeing who's watching what. With the Fool's free My Watchlist service, we have tens of thousands of people telling us the businesses that have, for whatever reason, piqued their interest.

The most-watched biotech stock is ...
Looking at the aggregate data, we see that Gilead Sciences (Nasdaq: GILD ) is above the rest in terms of watch interest, the percentage of people keeping an eye on biotech stocks in general who are specifically watching each company. And for good reason. As CAPS Member CarolinaMatt wrote last week:

Yes I get it. This company is no longer the high-flying early stage pharma star with a everything under patent and profits growing as fast as it can ramp distribution.

But this is no old super-slow moving huge pharma company either. Pricing is at a 2011 P/E of about 9X which suggests maturity and minimal EPS growth. But this company is still projected to grow EPS at 15ish% over the next 3-5 years. Even if they fall short and come in at more like 10-11% EPS gains it is a bargain in the drug space

Here are the rest of the top 15 most-watched companies in the industry with their watch interest along with the stocks' CAPS rating to show the sentiment of our investing community.

	Company	Market Cap (millions)	CAPS Rating (out of 5)	Watch Interest
1	Gilead Sciences	$33,828	****	25.5%
2	Exelixis (Nasdaq: EXEL )	$1,451	****	9.3%
3	Amgen	$49,495	***	2.8%
4	Dendreon (Nasdaq: DNDN )	$5,444	**	2.6%
5	ImmunoGen	$611	***	2.4%
6	Maxygen	$157	****	2.2%
7	MannKind (Nasdaq: MNKD )	$491	**	2.0%
8	PDL BioPharma (Nasdaq: PDLI )	$827	****	1.8%
9	Celgene	$26,639	****	1.8%
10	Geron (Nasdaq: GERN )	$661	***	1.7%
11	Vertex Pharmaceuticals	$9,728	***	1.5%
12	Arena Pharmaceuticals (Nasdaq: ARNA )	$184	**	1.5%
13	Human Genome Sciences	$5,165	**	1.4%
14	Orexigen Therapeutics	$138	**	1.4%
15	Biogen Idec	$17,626	***	1.1%

thanks fool.com

there is some interesting phase II data I will cover tomorrow.
Solid tumors and epigentics. I can give some info on that field--is epigenetics drugable?

Well, well look who decided to post.

Biotech, like everything else, has been taking it hard. There are still a few buyers out there though. Let's shuffle through some trials and see who is still a bull.

today: CELG

Revlimid is changing the how multiple myeloma (blood cancer) is being treated.

some background:
Lenalidomide (Revimid) is used to treat a type of blood disorder known as myelodysplastic syndrome. Lenalidomide is also used along with other drugs to treat people with the cancer known as multiple myeloma. CELG also has an impressive pipeline in oncology solid tumors that should see fruition in the next few years.
Revlimid is used in conjunction with an anti-inflammatory drug called dexamethasone in patients.

CELG closed up today in average trading (avg. volume ) up 64 cents to 54.32.

LOOK, at CELG. No Respect.

Company makes record earnings and not a kiss to be found.

Anti-cancer drugs apparently are not the in thing right now. Must be those Amgens, Vertex drugs making the news as hepatitis is getting love now.

cheers.

Anadys Pharmaceuticals Upward Momentum Looks to Continue (ANDS)

Written on Wed, 04/07/2010 - 11:34

By Chip Brian

SmarTrend identified an Uptrend for Anadys Pharmaceuticals (NASDAQ:ANDS) on December 03, 2009 at $2.58. In approximately 4 months, Anadys Pharmaceuticals has returned 7.7% as of today's recent price of $2.78.
Anadys Pharmaceuticals is currently above its 50-day moving average of $2.20 and above its 200-day moving average of $2.23. Look for these moving averages to climb to confirm the company's upward momentum.
SmarTrend will continue to scan these moving averages and a number of other proprietary indicators for any shifts in the trajectory of Anadys Pharmaceuticals shares.

ANDS

ANDS looks to make a run shortly with data being presented next week in Austria.

Here is the press release:

"Safety and Antiviral Activity of ANA598 in Combination with Pegylated Interferon alpha-2A Plus Ribavirin in Treatment-Naive Genotype 1 Chronic HCV Patients"; April 15, 2010.

Anadys will present preliminary antiviral response and safety results from its ongoing Phase II study of ANA598 in HCV patients, in which ANA598 is being dosed for 12 weeks in combination with pegylated interferon and ribavirin (SOC). For the group receiving ANA598 at 400 mg twice-daily (bid) plus SOC, antiviral response and safety data through eight weeks will be presented, which data further confirm the profile demonstrated for ANA598 at 200 mg bid. Antiviral response and safety data for the complete control group receiving placebo plus SOC will also be updated through eight weeks. Data through 12 weeks will be presented for the group that received ANA598 200 mg bid plus SOC.

Poster Presentation on ANA598 Preclinical Data:

"Enhanced In Vitro Antiviral Activity of ANA598 in Combination with Other Anti-HCV Agents Support Combination Treatment"; April 16, 2010.

Anadys will present preclinical data showing enhanced activity and suppression of resistance when ANA598 is combined in vitro with other anti-HCV agents.

The abstracts for both presentations can be accessed through the EASL website at www.easl.ch. Thanks Yahoo finance.

More on this later tonight after I do some reading.

Updated 101: The Market Trend is BULLISH

I was looking forward to having a drink with a LEGAL hound tomorrow. 4-1-89 was truly a great day.

"The Master's hand that fashioned you, will never make another, to take your place in heart or home, though we live for ages.

Time takes away the edge of grief, but memory turns back every leaf"---Tenneyson

Happy Birthday Hound.

coming: updates NVLT, ANDS, and ISIS.

In Memormiam---Gus

Gus

April 1, 1989- October 19, 2009

RIP

My best friend.

I did not see any data posted from NVLT in the last three days. Either it's pending release or what I read of pending data is bogus. Nonetheless, when I get it, you will. Stay tuned.

BTW--I have an order in if gets back into 70's again, i'm getting more.

Who's employed?

ME!

Well now that I'm back in the game in the discovery research business, this site will pick up. I HAVE to! I'm reading now and looking at all things up and coming. This rocks and life is good. Stay tuned. Please come back; this site is will be very informative. No hard feelings towards small biotech but big pharma is good.

Sorry for the "layoff"

LOL--

I'll try to post the results soon, but I was recently laid off from my job and have been actively pursuing other positions. All is good, a positive attitude will always get you ahead.

Otherwise, there are a handful of companies that are getting good trial data that will be explained here, for one see Jazz Pharma. wow.

Trial information explained tomorrow. Stay positive during hard times!

I have several write-ups about some of these abstracts that I'm working on. I'm shutting it down for the rest of today and heading up to Hollywood for the weekend for some R & R.

Check back, when I'm laying by the pool at the London West Hollywood, there may be a post or two. Cheers.

BTW, NVLT is trading now at 74 cents, up a nickel. I see a trend here.....

In vivo pharmacokinetic and pharmacodynamic behavior of NOV-002, a redox-modulating glutathione disulfide mimetic

Abstract #4. Session Title: Biochemical Modulators

NOV-002 is a novel formulation of oxidized glutathione (GSSG) currently in a pivotal Phase 3 clinical trial in advanced non-small cell lung cancer. In clinical trials conducted to date, NOV-002 administered in combination with standard chemotherapeutic regimens has resulted in increased efficacy (survival, tumor response) and improved tolerance of standard chemotherapy (e.g. enhanced hematological recovery, immune stimulation). Recently, we showed that the proliferative effects of NOV-002 in the pre-myeloid HL-60 cell line is commensurate with stress-induced S-glutathionylation and activation of kinase pathways (AKT, JAK2 and STAT5) that are known to regulate hematopoiesis. The present investigation was undertaken to characterize the plasma pharmacokinetics of NOV-002 in C57 black mice and to determine if the drug caused S-glutathionylation of plasma proteins that might be used as surrogate biomarkers for drug efficacy. Using HPLC-MS, NOV-002 was measured in plasma at various times following a single intraperitoneal dose. Peak plasma concentrations were observed 10 min following administration of NOV-002 and were diminished by 60 min. Fluorescence based methods were used for quantification of protein thiol content and three S-glutathionylated plasma proteins were identified by mass spectrometry, serine proteinase inhibitor, contrapsin, and a-1-antitrypsin1-6 precursor. These preclinical pharmacokinetic and pharmacodynamic results provide evidence that, as in cell systems, NOV-002 administration in vivo results in generation of a transient oxidative signal that may trigger a variety of redox-regulated biochemical cascades. Such correlates could help to understand and predict clinical responses to treatment with NOV-002.

NOV-002, a redox-modulating glutathione disulfide mimetic, leads to calcium influx and nitric oxide generation through eNOS activation in myeloid c

Abstract 3: Session: NF-kB, Oxidative Stress, and Other Pathways in Cellular Drug Responses


NOV-002, a glutathione disulfide mimetic, is currently in a pivotal Phase 3 clinical trial in advanced non-small cell lung cancer. In clinical trials conducted to date, NOV-002 administered in combination with standard chemotherapeutic regimens has resulted in increased efficacy (survival, tumor response) and improved tolerance of standard chemotherapy (e.g. enhanced hematological recovery, immune stimulation). Recently, we showed that the myeloproliferative effect of NOV-002 in the pre-myeloid HL-60 cell line occurs in parallel with stress-induced S-glutathionylation and activation of kinase pathways (AKT, JAK2 and STAT5) that are known to regulate hematopoiesis. NOV-002 treatment produces oxidant signals intracellularly and at the cell surface. HL60 cells express the cell surface enzyme gamma-glutamyl transpeptidase (GGT). NOV-002 is a substrate for GGT and its cleavage alters the intracellular redox potential. Here we show that NOV-002 treatment in HL60 cells mediates changes of the plasma membrane electrical potential as detected by the fluorescent probe, bisOxonal. These changes were concurrent with time- and dose-dependent increases in the accumulation of intracellular Ca2+ as detected by Fura-2-AM and Fluo-3-AM fluorescent dyes. These effects were abolished by the addition of an extracellular Ca2+ chelator (EGTA) and decreased by the intracellular chelator, BAPTA-AM. These data suggest that NOV-002 induced calcium signaling involves entry of extracellular Ca2+ across the plasma membrane. Microarray analyses highlighted that NOV-002 treatment impacts expression of proteins involved in calcium signaling and nitric oxide (NO) metabolism pathways. NO generation following NOV-002 treatment was decreased by ~80% in HL60 cells transfected with siRNA to deplete eNOS levels. Overall, NOV-002 mediated alteration of cell surface redox status and transmembrane potential resulted in an induction of calcium influx, followed by NO generation through eNOS activation. These events may be pertinent to myeloproliferation that has been observed in cancer patients treated with NOV-002 plus standard chemotherapy.