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ADLR's PDUFA date for Entereg (Postoperative Ileus) is May 9th 2008. Will the FDA approve the drug?
AnswerVotes
Yes, full market approval6
No, FDA will not approve2
Will receive approvable letter3
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Biotech News
Genentech has revised its timeline forecast for availability of final efficacy and safety results for the C-08 study from 2010 to 2009. The study, involving... An abstract submitted to the Annual Meeting of the American Society of Clinical Oncology (ASCO), entitled "Phase Ia Safety and Pharmacokinetic Study of Oral NV-196... Array BioPharma and AstraZeneca announced plans for two additional randomized Phase 2 trials for AZD6244 (ARRY-886). The trials, which will begin during the second half... Omrix Biopharmaceuticals announced that Larry Ellberger was named Chairman of the Board of Directors and Pamela McNamara was elected a Director at the Company's 2008... Valeant Pharmaceuticals announced that the Food and Drug Administration (the FDA) has entered an administrative order in the public interest to stay the approval of... Sepracor announced that its Board of Directors has approved the appointment of Robert F. Scumaci as Executive Vice President and Chief Financial Officer. Mr. Scumaci... Human Genome Sciences announced that Kevin P. McRaith has joined the Company as Vice President, Hepatology Franchise. Mr. McRaith, formerly Vice President, Sales & Marketing-... Theratechnologies announced a strategic agreement with both the Massachusetts General Hospital ("MGH") and Dr. Steven Grinspoon to explore the use of tesamorelin in relative growth... Allos Therapeutics reported interim response and safety data from the Company's pivotal Phase 2 PROPEL trial of PDX (pralatrexate) in patients with relapsed or refractory... MorphoSys AG announced that at the Company's annual shareholder meeting on Wednesday, May 14, 2008, its shareholders confirmed the reappointment of Dr. Gerald Moller, Dr....

Biotech Milestones
Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to... Amarillo Biosciences announced that the U.S. Food and Drug Administration has allowed the Investigational New Drug (IND) application submitted by the Company to test its... Medivation announced that, based on its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company plans to begin a pivotal confirmatory... DURECT announced positive results from a Phase IIa clinical trial for ELADUR, DURECT's proprietary investigational transdermal pain patch. In this study of patients suffering from... Auxilium Pharmaceuticals completed patient enrollment in the Company's second U.S. phase III pivotal trial (CORD I) and its Australian phase III study (CORD II) of... Pain Therapeutics and King Pharmaceuticals announced positive results of a Phase III study of Remoxy(tm) in patients with chronic pain. Over 400 patients with osteoarthritis... DURECT announced that the pivotal Phase III trial for Remoxy had successfully met its primary endpoint (p<0.01) that was prospectively defined by the U.S. Food... Phase 2 data expected in 2Q08. ADVENTRX Pharmaceuticals has completed patient enrollment in its Phase 2 clinical trial of ANX-510, or CoFactor, for the treatment... Acorda Therapeutics announced results from a thorough QT study of Fampridine-SR. This study evaluated the potential to cause an increase in the electrocardiographic QT interval.... The Medicines Company announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's supplemental new drug application (sNDA) for a modified dosing... Phase 1. Phase 2 is expected to begin in 2Q08.... DOR BioPharma announced that patient enrollment is commencing in a randomized, double blinded, placebo controlled Phase 2 clinical trial of orBec for the prevention of... Theratechnologies announced that the last patient has completed 26 weeks of treatment in the confirmatory Phase 3 trial testing tesamorelin in HIV-associated lipodystrophy. The Company... Cortex Pharmaceuticals was notified by the German regulatory agency which approves the use of narcotic drugs that it can proceed with the trial which will... Wyeth Pharmaceuticals and Progenics Pharmaceuticals announced preliminary findings from the first of two phase 3 clinical trials of intravenous methylnaltrexone being evaluated for the management... Eurand announced that the New Drug Application (NDA) for Zentase (EUR-1008) was accepted and has been granted priority review by the United States Food and... Labopharm completed North American Phase III clinical trial for its once-daily formulation of the antidepressant trazodone (study 04ACL3-001) achieved statistical significance for the primary efficacy... Arena Pharmaceuticals announced positive results from a single dose Phase 1a clinical trial of APD791 and the initiation of a multiple dose Phase 1b clinical... GTC Biotherapeutics announced that ATryn has completed enrollment in the pivotal study for the treatment of patients with hereditary antithrombin deficiency, or HD, undergoing high-risk... Favrille announced that it has reached the data cutoff date for the Company's Phase 3 registration trial of Specifid (mitumprotimut-T, formerly FavId) following Rituxan in... Active Biotech AB presented the final results of the previously reported clinical Phase I study of the cancer project ANYARA in combination with Taxotere in... Genaera announced that the investigational new drug (IND) application submitted to the US Food and Drug Administration (FDA) for trodusquemine (MSI-1436) in type 2 diabetes...



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What is BiotechWatch Premium?

BiotechWatch Premium is an online dynamic database of biotechnology companies. For investors and industry professionals interested in the biotechnology sector, BiotechWatch Premium is invaluable because it is the only resource that allows users to search, sort, and browse over the entire biotech sector based on everything from stock fundamentals to clinical trials. BiotechWatch Premium offers as much or as little sophistication as a user desires making it ideal for the everyone from novices to large cap fund managers.


What type of information does BiotechWatch Premium provide?

BiotechWatch Premium provides a broad range of information, from traditional fundamentals such as 52 week high and low, shares outstanding, and volume of shares traded, to derived values based on these and other parameters. All products in clinical development are tracked as well, so an investor can follow a drug's development process and its development milestones.

All information is as up-to-date as possible, meaning that all numerical information is updated every five minutes from a 20-minute delayed feed. Company news, financing information, and clinical trial details are updated constantly by our researchers. In most cases, these are added to our database moments from the time they become public information.


What interesting features does BiotechWatch Premium offer?

Numerical and clinical information can be sorted and prioritized across all publicly traded biotechnology companies. This provides insights as to how a company or group of companies compares within the larger context of the biotech sector.

When searching for companies to invest in, you may want to narrow your search to companies that have a particular numerical (stock price, for example) in a specific range of values. BiotechWatch Premium helps you decide what range might be useful by displaying the distribution of that numerical across all the companies in the database (or all companies within the search you are conducting at that time) in an easy-to-read histogram. These histograms are dynamically updated to provide a current snapshot of the numerical in question. By limiting the range values for a particular numerical, you are narrowing down to the companies that you would like to focus on. Several search restrictions may be imposed concurrently to narrow your search to fit a razor-sharp definition of companies of interest to you. Search parameters can be added and removed until the search returns companies of interest.

You can save sets of search parameters for later recall, thus giving you one-click access to your custom searches.

Throughout BiotechWatch Premium, you can click on a company's name to see its detail page. The detail page provides news, financing information, products under development and their clinical status in both tabular and detail formats.

Once you have your search narrowed to companies that interest you, you can sort them based on any parameter using simple sorting arrows.

You can choose from a number of predefined view options or create custom views that display exactly the columns of information you wish to see. Custom views can be saved by name for later recall or to easily switch between custom views you have created.

A print view is available that makes printing hard copies of your search results easy and convenient.

Using a saved search, you can save a portfolio of companies for later retrieval. You can then search within those companies, or even save searches within a list of specific companies.


How does one use the database or perform searches?

Beginning users will probably want to use one of the many default searches offered in BiotechWatch Premium. These give the user a one-click snapshot of companies that are interesting because they stand out in some way.

For example, companies that have a market capitalization (the value of all shares of the company multiplied by the current stock price) of least $50 million dollars, at least 2 years of cash reserves (based on the last quarter's rate of spending and cash reserves), products in late-stage clinical trials, and a stock trading price in the bottom half of its trading range over the past year may be undervalued companies with high growth potential. The default search page gives users easy access to a table of companies that meet these criteria at any given time.

Expert users may wish to perform similar types of searches, but they are afforded the option to customize each parameter of the search using over 25 unique searching and sorting parameters. A list of all searching and sorting parameters tracked by BiotechWatch Premium appears at the end of this page.

Quick searches offer users the ability to quickly enter in a keyword, company name, or list of ranges for fundamentals of interest and immediately see the companies that match those search parameters.


How many companies does BiotechWatch follow?

BiotechWatch tracks biotech and medical device companies. Our focus has been those that are publicly traded on the US stock exchanges (NASDAQ, NYSE and AMEX). We are in the process of adding European, private, and large pharmaceutical companies. BiotechWatch currently follows more than 600 companies and over 5000 unique products and clinical trials for these companies.


How does BiotechWatch Premium compare to other information sources on the Internet?

BiotechWatch Premium is unique as it allows the sorting of both numerical and company information across the entire publicly traded biotech sector. The database is interactive and can be customized to meet an individual's needs. It is continuously updated to insure that it is as up-to-date and accurate as possible. Other information services provide news releases, but none provides this constellation of features. While the database is very sophisticated, the average person can master it in 2-3 sessions. It is worthwhile getting to know how to use the BiotechWatch Premium database, as its functionality is unrivaled in the biotech sector.


What doesn't the BiotechWatch Premium database do?

BiotechWatch Premium does not provide stock charts or full-text news releases. The BiotechWatch Premium database is designed to be used with other traditional investment tools and services, many of which provide news releases and charts for free.

BiotechWatch does not track large cap pharmaceutical companies because its focus is on the more volatile and information-sensitive biotech sector. The largest company currently tracked is Amgen, which in the broader market is generally considered a small to mid-cap company. The smaller, usually newer, companies that BiotechWatch tracks have the most growth potential and BiotechWatch offers users detailed information about them so they may make the most informed investment decisions possible.


What if I need help while in the Premium database?

Definitions provided throughout BiotechWatch Premium help in understanding terms (both investment terms and our searching and sorting features) that may be unfamiliar. In addition, a highly detailed tutorial is provided to guide users in performing searches and fully utilizing the functions of the database. Technical assistance is available for registered users.


I am a user and I want to know more about how to use BiotechWatch Premium. Where do I begin?

Take our detailed tutorial. It will explain all of the functions of BiotechWatch Premium. Many users just log in and poke around and figure out how to use BiotechWatch Premium in a way that works for them. The small "def." buttons provide context-sensitive help about potentially confusing names and terms.


Who can benefit from using the BiotechWatch Premium database?

Anyone who is interested in the biotechnology sector can benefit. This includes average investors, money and fund managers, and professionals in the biotech industry.


What specific company characteristics are tracked by BiotechWatch Premium?

  • Company Fundamentals:
    • Stock Price
    • 52 Week High and Low Price
    • Shares Outstanding
    • Cash on Hand
    • Years of Cash
    • Market Capitalization
    • Daily Trading Volume
  • Derived Statistics:
    • Market Cap / Cash on Hand
    • Market Cap Less Cash on Hand
    • Price Less Cash Value Per Share
    • Cash Value Per Share (Cash / Shares Out)
    • Price / 52 Week Range
    • 52 Week High / Price
    • 52 Week Low / Price
    • 52 Week High Less Price
    • Price Less 52 Week Low
  • Company Information:
    • Clinical Trial Phases (For Each Product in Development)
    • Total Number of Products
    • Total Number of Clinical Trials
    • Medical Specialties
    • Diseases and Conditions Treated
    • Expected Development Milestones
  • Additional Search Parameters:
    • Browing by Company Name
    • Browsing by Medical Specialty and Disease
    • Keyword Seaching on Any Field