60 Minutes on J. Craig Venter: Designing Life

J. Craig VenterImage via WikipediaJ. Craig Venter: Designing Life
June 12, 2011 5:00 PM

Steve Kroft profiles famous microbiologist J. Craig Venter, whose scientists have already mapped the human genome and created what he calls "the first synthetic species."

(CBS News) 
This story was first published on Nov. 21, 2010. It was updated on June 12, 2011.
For generations, scientists have wrestled with the idea of creating new forms of life in the laboratory. Now that age is upon us.

Watch the Segment »


Cancer Clinical Trials and Treatments Late Stage Developments

Six bottles of chemotherapeutic agents for inj...Image via WikipediaFrom FierceBiotech

For the cancer drug research enthusiast, this report might read in places like a special oncology edition of a gun magazine. Indeed, there are plenty of weapons against cancer to read about here. Several of the drugs listed here represent the advancement of relatively new methods of attacking cancer, including "armed antibodies" and cancer-killing viruses.

 In addition, decades of basic research into the molecular drivers of cancer growth are bearing fruit for drug developers. Not only are these companies making progress in clinical trials, they have landed buyout deals and lucrative partnerships. It's also clear that relatively small companies like Aveo Pharmaceuticals and Curis are making inroads along side the big boys like Pfizer and Roche.

There are 10 late-stage drugs listed in this report, but this editor hesitates to call them the "Top 10" only because there are so many variables to consider to rank them in such a way objectively. Yet these 10 drugs have certainly been generating news and, in most cases, lots of interest among investors and the medical community. All of the drugs have reached pivotal trials for at least one type of cancer.
Here's the list in alphabetical order by each drug's most commonly used moniker, whether that is its alphanumeric code name or generic name. As always, please let us know whether you think there are cancer drugs in pivotal trials that you think should have been on this list or ones on this list that shouldn't be.

1. Carfilzomib - multiple myeloma
2. Crizotinib (PF-02341066) - lung cancer
3. GDC-0449 (vismodegib) - basal cell carcinoma
4. OncoVex - advanced melanoma
5. PLX4032 (RG7204) - melanoma
6. Ponatinib - leukemia
7. SGN-35 (brentuximab vedotin) - Hodgkin's lymphoma, anaplastic large cell lymphomas
8. Tivozanib (AV-951) - advanced renal cell carcinoma
9. T-DM1 (Trastuzumab-DM1) - breast cancer
10. XL184 (cabozantinib) -  prostate cancer


Killer E. coli Strain Identified in German Outbreak Through Genomic Sequencing: Life Technologies

These are e Coli.Image via WikipediaAs of June 15, the number of people who were ill due to the outbreak of a new E. coli strain in Europe had reached 3,244, according to the Associated Press (AP). Most of the reports have been in Germany, and 784 of the total had developed a serious complication that could lead to kidney failure. AP reported that 37 people have died in Germany, and one person died in Sweden.

The German government has said that it could be a while before the outbreak could be tracked to its ultimate source. Critics have lost no time carping about the way the crisis has been handled.

While the epidemiology has been cumbersome, the genomic sequencing that characterized the pathogen wasn’t. It took all of three days for teams at the University Medical Centre Hamburg-Eppendorf and BGI (formerly known as Beijing Institute of Genomics) to complete the sequence. The research groups used Life Technologies’ Ion Personal Genome Machine (PGM). Simultaneously, University Hospital of Muenster in Germany and Life Technologies confirmed these results.

SOURCE: http://www.lbl.gov/Publications/Curren...Image via Wikipedia

Information Uncovered by Sequencing

“Bioinformatics analysis revealed that this E. coli is a new strain of bacteria that is highly infectious and toxic,” BGI said in its report, issued on June 2. The bacterium is an enterohemorrhagic E. coli (EHEC) serotype O104 strain, which has never been involved in any E. coli outbreaks before, the institute explained.
Described as super-toxic, the strain has 93% sequence similarity with the enteroaggregative E. coli (EAEC) 55989 strain isolated in the Central African Republic and known for causing serious diarrhea. Furthermore, the scientists reported, it has “acquired specific sequences that appear to be similar to those involved in the pathogenicity of hemorrhagic colitis and hemolytic-uremic syndrome.”
Model of successive binary fission in E. coliImage via Wikipedia
The bacteria also produce extended-spectrum beta-lactamases, enzymes that confer resistance to most beta-lactam antibiotics including penicillins, cephalosporins, and the monobactam aztreonam.
University Hospital of Muenster and Life Technologies further noted that “the bacterium at the root of the deadly outbreak in Germany is a new hybrid type of pathogenic E. coli strain.” Their data reportedly showed the presence of genes typically found in two different types of E. coli: EAEC and EHEC.

The Instrument that Did the Sequencing

The Ion PGM chip-based sequencing technology connects chemical and digital information through the use of semiconductor technology. It uses a parallel array of semiconductor sensors to perform real-time measurement of the hydrogen ions produced during DNA replication.

A high-density array of wells on the ion semiconductor chips provides millions of individual reactors, while integrated fluidics allows reagents to flow over the sensor array. The combination, Life Technologies says, enables the direct translation of genetic information to digital information.
 A close-up of E. Coli 1057:H7Image via Wikipedia
“What’s different about it is that it doesn’t use cameras or lasers,” Life Technologies CEO Mark Stevenson told GEN. “We measure the pH change in each well with a semiconductor chip.”

The E. coli crisis in Germany appears to have provided the proof of principle and a field test with highly visible results for the Ion PGM. Life Technologies acquired the technology when it bought Ion Torrent in 2010 for $375 million in cash and stock. Life Technologies began selling the instrument to the marketplace for less than $100,000, calling it an “easy-to-use, highly accurate benchtop instrument optimal for mid-scale sequencing projects such as targeted and microbial sequencing.”

When Ion Torrent introduced the technology in 2007, it expected the innovation to democratize research, enabling every lab to have a sequencer on its bench. At the time, the company said it had planned to sell the machine for $50,000 apiece—about one-tenth the cost of existing instruments. Ion said that the instrument could perform a single sequencing “run” for about $500 in one hour.

Low-temperature electron micrograph of a clust...Image via Wikipedia

Detection in Food

The availability of new technologies has indeed greatly facilitated the genomic sequencing of this potentially lethal bacterium. Life Technologies has also developed a tool to test foods thought to be associated with the outbreak.

On June 6, shortly after reporting results from its sequencing efforts, the firm reported that it had completed development of a custom assay to detect the bacterium. Shipments of the TaqMan® E. coli O104 detection kit are now in Europe.

“A qPCR-based assay test is the most accurate method to detect harmful food-borne pathogens because a positive result indicates the presence of that particular strain’s DNA in the food sample that is being tested,” explained Nir Nimrodi, head of food safety at Life Technologies.
 Escherichia coli on Macconkey Agar PlateImage via Wikipedia
“It is also the fastest. While traditional laboratory testing methods can take up to 10 days for results, this test can determine the presence or absence of the European pathogen in 10 to 24 hours, depending on the sample type and size.”

It is hoped that the TaqMan E. coli O104 detection kits will provide an answer to the question that has received a variety of answers since the initial E. coli outbreak: Where did it come from? Originally, on May 26, health officials pointed to E. coli-contaminated cucumbers from Spain as culprits, but researchers later concluded that the cucumbers were contaminated with a different strain.

Suspicion then moved to bean sprouts but faded away after it was found that 23 of 40 samples from the suspect farm tested negative. As of June 8, focus had shifted back to cucumbers, as a CUCO (cucumber of unknown country origin) that had sickened a family in eastern Germany was found to be contaminated with the outbreak strain. The cucumber was discovered in the family’s compost, but there is no conclusive evidence that it’s the source.

Then on June 10, Reinhard Burger, president of the Robert Koch Institute, said that even though no tests of the sprouts from the suspect farm had come back positive for the E. coli strain behind the outbreak, an investigation into the pattern of the outbreak had produced enough evidence to indict the sprouts. German authorities said that they haven’t yet been able to resolve how sprouts at a farm became contaminated.
Along the search for clues about the source of the killer E. coli food bug, a restaurant in the northern German town of Luebeck and a festival in the northern city of Hamburg have also come under suspicion. The European Union has sent food safety experts to Germany to help authorities there identify the source of the deadly E. coli epidemic.

Stevenson noted that “a concern for the global healthcare industry is the ability to identify these pathogens as they arise and then be able to detect and screen for them rapidly and inexpensively.” Like with the Ion PGM, as novel pathogens continue to emerge, so will the need for similar disruptive but relatively affordable technologies.
Escherichia coli in Endo's agarImage via Wikipedia

Isocitrate Dehydrogenase of Escherichia coli. ...Image via Wikipedia

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Anacor Pharmaceuticals and Psoriasis Make Strides With Phase IIb Trials

Treatment ladder for PsoriasisImage via Wikipedia Anacor Pharmaceuticals (NASDAQ:ANAC) announced today preliminary results from its Phase 2b trial of AN2728 for the treatment of mild-to-moderate plaque-type psoriasis. The trial enrolled 68 subjects randomized in a 2:1 ratio, AN2728 to vehicle. Subjects treated with AN2728 showed improvement over vehicle at each of the recorded timepoints during the 12-week study period with peak efficacy of 26% occurring after six weeks of treatment with AN2728.

Amgen submits BLA for XGEVA

AMGen Corporate Logo, 1983Image via WikipediaTHOUSAND OAKS, Calif., June 27, 2011 /PRNewswire/ --

Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating XGEVA versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrate that XGEVA significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.

 Bone metastasis-free survival is a composite measure of the development of bone metastases or death.
"The successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK Ligand pathway to penetrate bone," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.  "XGEVA has the potential to become a significant advance for patients with castrate-resistant prostate cancer who currently have no treatment options to help prevent the spread of cancer to their bones."


Pfizer's To Present Lung Cancer Data July 3-7

Image representing Pfizer as depicted in Crunc...Image via CrunchBase Pfizer Inc. will present early and mid-stage data from its lung cancer portfolio, including PF-00299804 (PF-299) an investigational, oral, pan-HER inhibitor;1 and crizotinib, an investigational, oral, first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK,2 at the International Association for the Study of Lung Cancer’s (IASLC) 14th World Conference on Lung Cancer (WCLC), July 3-7 in Amsterdam, The Netherlands.

“While lung cancer remains a difficult-to-treat disease, we’re learning more about how therapies like crizotinib and PF-299 may be able to specifically target ALK or the HER pathway, respectively, and how this may lead to more rationally selected and personalized therapy,” said Maurizio Voi, MD, Thoracic Tumor Strategy Lead, Pfizer Oncology. “Data being presented show survival outcomes for PF-299 and crizotinib, as well as quality-of-life or patient-reported outcomes after treatment for patients with non small cell lung cancer, which represent important considerations in determining the best treatment option for these patients.”

First Presentation of PF-299 Preliminary Overall Survival Data


GEN | News Highlights:Firms Report Promising Data for Type 1 and 2 Diabetes Candidates at 71st Annual ADA Meeting

Insulin ApplicationImage via WikipediaGEN | News Highlights:Firms Report Promising Data for Type 1 and 2 Diabetes Candidates at 71st Annual ADA Meeting

GEN | Analysis & Insight: Cloud Computing Augments Clinical Trial Process

GEN | Analysis & Insight: Cloud Computing Augments Clinical Trial Process

(Page 1 of 1)
    Pharma and biotech companies have so far tended to use cloud computing services for drug development research, not clinical trials. IBM and other smaller tech companies would like to change all that, though. Additionally, applying cloud computing for data analysis to aid patient care is catching on. As cloud computing extends to clinical data analysis, which would be considered private information, security will loom larger as an issue for drug development companies. The benefits of using the cloud to store, manage, and analyze clinical data are similar to those for other drug development work. The cloud offers time on gigantic, dispersed infrastructures on a pay-as-you-go basis. It is estimated that 8–12% of clinical trial costs come from the need to move data around among various trial sites, comparing the data as it is being created, according to Erich Clementi, vp of strategy and GM of enterprise initiatives at IBM. Additionally, for projects that require heavy data crunching, cloud computing enables vast amounts of processing at a lower cost. For example, Jeffrey T. Leek, Ph.D., assistant professor at Johns Hopkins Bloomberg School of Public Health, and colleagues used an internally developed, open-source cloud-computing platform called Myrna for calculating differential gene expression in large RNA sequencing datasets. Running an analysis for a single RNA sequence on one laptop could take up to three weeks to complete, Dr. Leek explained. In contrast, by renting computers for cloud computation services for $65, Dr. Leek said he could get results back in an hour and 45 minutes.  Continued....


Recent News Concerning HPV in Men, HPV is now linked to causing Throat Cancer

Throat Cancer Linked to HPV

A sharp rise in a type of throat cancer among men is increasingly being linked to HPV, the sexually transmitted human papillomavirus that can cause cervical cancer in women.

A new study from the National Cancer Institute warns that if recent trends continue, the number of HPV-positive oral cancers among men could rise by nearly 30% by 2020. At that rate, it could surpass that of cervical cancers among women, which are expected to decline as a result of better screening.

The study is to be presented this week at the annual American Society of Clinical Oncology meeting.

Between 1988 and 2004, the researchers found, the incidence of HPV-positive oropharynx cancers—those that affect the back of the tongue and tonsil area—increased by 225%. Anil Chaturvedi, a National Cancer Institute investigator who led the research, estimates there were approximately 6,700 cases of HPV-positive oropharynx cancers in 2010, up from 4,000 to 4,500 in 2004, and cases are projected to increase 27% to 8,500 in 2020. 

Find out more about HPV  Currently, Merck markets the vaccine Gardisil


Bristol melanoma drug extends survival in study


NEW YORK | Mon Mar 21, 2011 6:37pm EDT

(Reuters) - Bristol-Myers Squibb Co's eagerly anticipated experimental drug ipilimumab extended survival of previously untreated patients with advanced melanoma in a late stage study, the company said.

Details of how much longer patients who were suffering from the deadly skin cancer lived after taking the highly promising Bristol drug will be unveiled at a major medical meeting in June.

Bristol-Myers shares were up 4.3 percent at $27.10 in extended trading from their New York Stock Exchange close at $26. They initially jumped 5.7 percent after news of the clinical trial's success was reported.

Extending overall survival -- the primary goal of the study -- is considered the gold standard for cancer drug trials.

U.S. health regulators are expected to approve ipilimumab this week based on results of a different study of patients who had received prior treatment for advanced melanoma.  In that study the Bristol-Myers drug extended survival by an average of four months, which was seen as a major advance for a disease littered with drug failures and for which there are really no effective treatment options.

The Food and Drug Administration in November delayed its approval decision to give it more time to review data on the medicine, setting a new action date of March 26. "Ipilimumab is an exciting drug, especially given the dearth of effective therapies for this bad form of cancer," Sanford Bernstein analyst Tim Anderson said in a research note.Advanced melanoma is one of the deadliest cancers and can quickly spread from the skin to internal organs, such as the brain. Once melanoma spreads to other organs the average survival is typically only six to nine months.

Genome study brings blood cancer into sharp focus

Bio Technician demonstrates the loading of the high tech 454 Life Science sequencing machine in the sequencing laboratory at the J. Craig Venter Institute in Rockville, Maryland, in this March 29, 2010 file photo.
Credit: Reuters/Larry Downing (UNITED STATES - Tags: SCI TECH)
Multiple Myeloma Research FoundationImage via Wikipedia(Reuters) - 

CHICAGO | Wed Mar 23, 2011 2:17pm EDT
Scientists have mapped out the full genetic code of 38 people with multiple myeloma, uncovering never-before suspected genes that play a role in the blood cancer and showing that a promising new drug might help.

Studying the genetic blueprint of so many people with this cancer allows researchers to have a much more comprehensive picture of what drives the cancer, and it gives drug companies much better clues about how to shut down the disease.

"If we compare the tumor genome to the normal genome, that gives us great clues about what makes a normal cell into a cancer cell," said Todd Golub of the Broad Institute and the Dana-Farber Cancer Institute, who helped lead the study published on Wednesday in the journal Nature.


PerkinsElmer Genomic Sequencing History

Genomic DNA is fragmented into random pieces a...Image via Wikipedia

Perkins Elmer has an extensive history in the genomic sequencing field and Dr. Craig Venter. Dr. Venter is a former researcher for The Institute for Genomic Research and founded the J. Craig Venter Institute.  Find out more  here:  http://www.jcvi.org/

Google finance:  NYSE:PKI

PerkinElmer Website

PerkinElmer Enters DNA Sequencing Market


PerkinElmer headquarters

In a move that heralds the growing importance of DNA sequencing to medical research and, eventually, diagnostics, PerkinElmer, the $1.9 billion (sales) maker of diagnostic tests, is entering the gene scanning market.

Rather than compete with makers of big DNA sequencing machines, PerkinElmer is creating a service business that will allow researchers to get human genetic data without owning their own DNA sequencers or high-powered supercomputers. Customers will be able to access and analyze DNA data on a password-protected computer cloud. The DNA sequencing and the data analysis will be compliant with regulations for lab diagnostics. Eventually, the will also comply with the Health Insurance Portability and Accountability act (HIPAA), which protects medical privacy.


Top Rated Biotechnolgy Stocks-The Street, Clinical Data Bulls Bears

Bulls & Bears
Image via Wikipedia

Top Rated Stocks: Biotechnology


Clinical Data Website

Clinical Data Pipeline

Clinical Data--Google Finance  CLDA

Clinical Data, Inc. Announces FDA Approval of Viibryd™ (vilazodone HCl) for Major Depressive Disorder

RSS Feed for Top Rated Stocks: Biotechnology

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: Biotechnology

Symbol Equity Rating











Source: TSC Ratings


Clinical Data: Bulls and Bears Round Two


NEWTON, Mass. (TheStreet) --Clinical Data (CLDA) scored a big victory with the approval of a new antidepressant, sending the stock price soaring 68% to $25.17 on Monday. Many of the company's shareholders and supporters, however, are looking for an even bigger payday when Clinical Data sells itself to the highest bidder.


Top BioHealth Investor Calls of the Month

Top BioHealth Research Calls of the Week (MNKD, PDLI, ILMN, CLDA, MRK, PFE, LLY, BMY, ALXN, SVNT, AMGN)

January 22, 2011 · Filed Under Financial, analyst calls, fda · Comment 
There were some key research calls in biotech and biohealth shares this week.  Over in our “top five analyst calls of the week” at 24/7 Wall Street we noted how one firm came out in defense of MannKind Corporation (NASDAQ: MNKD) on its implosion this week and another call was highlighting the potential upside value that remains in PDL BioPharma, Inc. (NASDAQ: PDLI) despite its patent fight concerns.  There were many other standout calls though in analyst coverage this last week in biohealth:

Illumina Inc. (NASDAQ: ILMN) has remained impressive after having been one of our “Best of Big BioHealth in 2010″ and was also at the start of the year listed as “an overvalued biohealth names with peers.” This week brought an analyst duel.  Citigroup raised its rating to BUY from Hold and the new price target is $85.00 per share.  Thomson Reuters has a consensus price target of $66.87 and the Citi target appears to be the street-high price target.  Elsewhere, RBC Capital Markets lowered the rating to Sector Perform from Outperform due to valuation.  Illumina’s 52-week range is $34.25 to $71.07, and at $68.75 it has a market cap now of $8.6 billion.

Clinical Data Inc. (NASDAQ: CLDA) will be one to watch this coming week after the FDA approved its antidepressant drug to be sold under the brand name Viibyrd.  Shares closed at $15.03 on Friday but were much higher after the news and the 52-week trading range is $10.87 to $22.39.  What is interesting is that analysts already see peak sales above $2 billion as this antidepressant is believed to not interfere with sexual desire as much as in some rival drugs. The consensus price target is already $29.67 per Thomson Reuters data.

This week came a standout call in Big Pharma from Wells Fargo as the firm raised the sector to “Overweight.”  Wells Fargo raised Merck & Co. (NYSE: MRK) and Pfizer Inc. (NYSE: PFE) to Outperform ratings and also noted Eli Lilly & Co. (NYSE: LLY) and Bristol-Myers Squibb Company (NYSE: BMY) in the call.

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) closed the week out at $84.43 and has a 52-week range of $44.86 to $87.14.  There was an analyst duel this week.  Gleacher & Co. raised its rating to Buy while UBS cut its rating to Hold.

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) hit new 52-week lows this last week and closed at $10.20 versus a 52-week range of $10.16 to $23.46.  Its shares were downgraded to “Underperform” over at Bank of America Merrill Lynch after previous news in its business update of reports of batch failures with its new gout medication called Krystexxa.

Amgen Inc. (NASDAQ: AMGN) is set to report earnings on Monday and Thomson Reuters has estimates of $1.10 EPS and $3.8 billion in revenues; for the next quarter estimates are $1.31 EPS and $3.67 billion in revenues. At $56.97 shares are actually down slightly from 90-days ago and the 52-week range is $50.26 to $61.26.  This stock is getting toward its higher end of a 3 year trading band, so we expect that analyst will have to make some adjustments after earnings.  Thomson Reuters has an average price target above $65.00 currently.

At the end of December, we gave a list of Big Biotechs With the Most Upside in 2011.


Mannkind Is Having Increased Momentum and Volatiliy in January----This was the title before the stock was rejected by the FDA and the stock has declined considerably

Insulin syringes are marked in insulin "u...
Biotech and Pharmaceutical news:  Mannkind (MNKD)

Google Finance:  MNKD
Mannkind Corp.  Website
Mannkind Pipeline

I am cautious about Mannkind's approval chances with the FDA in the next coming weeks (FDA delayed Dec 29th decision 4 weeks) but I am optimistic about its chances of an increase in stock price while the FDA reviews Mannkind's approval for Afrezza for Diabetes.  Here are some news that has occurred for Mannkind in the past few weeks.  Continued


Another 2011 Standout: Peregrine Pharmaceuticals

Electron micrographs of hepatitis C virus puri...
Hepatitis C Virus Image via Wikipedia
Peregrine seems poised for growth in 2011
Written by Patrick Crutcher Tuesday, 11 January 2011

Zacks.com Profile:  PPHM

Peregrine Pharmaceutical Pipeline

Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) announced that it has initiated several trials in oncology and viral infections. They seem poised to garner attention from the Street over the coming months.


Top Biotech Stocks for 2011 and January Catalyst Event Dates

CLYDEBANK, SCOTLAND - APRIL 30:  Scientists wo...
Stocks Mentioned:  Dendreon, Human Genome Sciences, Eli Lilly, Cerus, Curis, Compugen, Spectrum Pharmaceuticals, Impax Laboratories, Exelixis, Medivation, Seattle Genetics, Corcept, PolyMedix, BioMarin, Endo PharmaceuticalsDepoMed, Mannkind, Orexigen Therapeutics, AstraZeneca, Clinical Data

Here are the Top Biotech Picks for 2011, Stocks Highlighted at the JP Morgan Healthcare Conference, News on Human Genome Sciences, Dendreon, Bargain Biotech Stocks, and January FDA Catalysts.

5 Bargain Biotech Stocks for 2011
Street Picks

NEW YORK (InvestorPlace) -- On July 8, 2009, I recommended five cutting-edge medical products and biotech stocks. Even factoring in the single dud of the group, you would still have an average return of more than 110%.

Do I have your attention? Good, because I've put together a list of the hottest bargain biotech stocks to buy for 2011. Some of the names will look familiar because I think the stocks still have legs, while others have been swapped out for new names that I think have more potential in the year ahead.

Here are the best biotech stocks to own now:


Raptor Pharmaceuticals in 2011

Ball and stick model of the cysteamine molecule.Cysteamine Image via Wikipedia
Interest for Raptor Pharmaceuticals is really picking up in 2011.  Here are the recent headlines for this up and coming Small Cap Pharmaceutical company.  It has a Pipeline for Rare Diseases and I expect 2011 to be a strong year for Raptor Pharmaceuticals if Clinical Trial results are successful.  Results for DR Cysteamine clinical trials is expected in 1Q 2011.  DR Cysteamine has clinical development programs including:

◦Nephropathic Cystinosis, a rare genetic disorder (Phase 3)

◦Non-alcoholic Steatohepatitis (NASH), a metabolic disorder of the liver (Phase 2)

◦Huntington's Disease, an inherited neurodegenerative disease (Phase 2)

Raptor Pharmaceuticals Stock Quote:  RTTP  Google Finance

Read more from their previous 10-K filings for the company's Strategic Development Plan here.

Find out more about their Clinical Pipeline here.



Spectrum Pharmaceuticals is Making Headlines in Early 2011

Spectrum Pharmaceuticals Submits Supplemental New Drug Application (sNDA) For Ready-to-Use Formulation Of FUSILEV(R) In Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology

Article Date: 06 Jan 2011 - 1:00 PST
Spectrum Pharmaceuticals (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission is in support of FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29 2011. FDA has up to 60 days to formally accept the submission.

"If approved, we believe a RTU formulation of FUSILEV, as the name implies, will be more convenient for the staff and easy to use. RTU formulation requires no reconstitution, and since it will also be of a higher strength than the currently available lyophilized formulation, the healthcare provider's time to administer FUSILEV to colorectal cancer patients will be considerably reduced," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.   Continued


2011 Biotech Preview: JP Morgan Healthcare Conference

Out of fog Bay Bridge and Golden Gate Bridge a...
JP Morgan Healthcare Conference 2011 Preview


The Street: Biotech 2011 Kickoff Party Investor Preview
By: Adam Feuerstein

The biotech industry descends on the City by the Bay starting Sunday for a week of investor meetings, networking, deal making and partying all centered on the 29th annual J.P. Morgan Healthcare Conference.

Biotech investor conferences are a dime a dozen but the J.P. Morgan confab is the oldest, largest and still the most important because of tradition, location (in the birthplace of biotech) and timing. Companies and investors come into this early January meeting with clean slates and use the forum to set goals and agendas for the next 12 months.

2010 was a mixed year for biotech. The biotech sector outperformed the S&P 500 (barely) but sentiment for a large part of the year was negative, dragged down by healthcare reform concerns, European drug price cuts and overall economic uncertainty. Many large institutional investors abandoned or scaled back healthcare investments in 2010 as a result. Drug approvals and merger-and-acquisition activity -- two vital measures of the health of the biotech sector -- were down in 2010.

What's in store for biotech in 2011? J.P. Morgan's senior biotech analyst Geoff Meacham, who will emcee next week's conference, is bullish:

"Looking to 2011, we think the tone in the sector will improve, and as a result, we are broadly bullish on the biotech sector, more than we have been over the past two years," Meacham told his clients in a Monday research note. "Historically, revenue upside (not EPS upside) has been a critical determinant of biotech outperformance, and in this regard the consensus revenue growth for the sector looks too low to us at 8%. More than 25 products could be in launch mode in 2011, which should fuel higher top-line growth for the sector and may drive multiple expansion. Couple this with a favorable M&A and capital markets environment as well as well-known risks from US/EU pricing that are largely assumed in models and we think that the biotech sector is well positioned in 2011."   Continued


BioPharma Investor Is Back In Business-Apologies for the Lack of Posts Last Month

Sorry for any delays.  I was out of town for the past month and was not able to keep up with the website.  The website will be back up and running in the next few days with new BioPharma News and Articles.  Again I apologize for a lack of quality posts last month, but again I will be working diligently throughout this year to provide the most up to date news and information on the hottest BioPharma Stocks and Clinical Trial news throughout 2011 without any more delays.  Thanks for your patience and support.

BioPharma Investor