RSS
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
Cast your vote now!


premium database
Username:
Password:

Not A Member?
Take the Tutorial

Log In to Trial View
Sign In


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...



Pay For View

In BiotechWatch's Pay for View section, we perform the searches for you. Accessing the entire publicly traded biotechnology sector, the BiotechWatch Pay For View searches integrate both clinical and financial information across over 500 companies: all that requires is for you to point and click. The searches below are performed with the BiotechWatch Premium database and are updated every 20 minutes. For a fully interactive and live experience where you can optimize and customize your searches, please access the Premium database directly. To register for BiotechWatch's Pay For View, please visit the Pay For View Registration Page.
If you have already registered, please Login and access your account.

The following searches are available:
Profitable biotech companies based on last quarter's financialsOf the over 500 biotech companies that are currently in the BiotechWatch database, only approximately 70 were profitable in the last quarter. Typically these companies have a product or products on the market and are generating revenues. Some biotech investors may find these companies desirableinvestment opportunities feeling that they are more stable and can be measured by traditional investment parameters.
Well financed biotech companiesBiotechnology companies are notorious for spending large amounts of money before developing their first product. Biotech companies with several years of cash on hand are in a better position in the marketplace and are more likely to complete development of a product. BiotechWatch has chosen 3 years of cash as a benchmark of more stable, better managed biotechnology companies.
Biotech companies that are relatively lower risk given their cash position and pipelineThese biotech companies have adequate financial resources, a high market capitalization and several products in clinical development or on the market. These companies may represent good investment opportunities in the biotechnology sector for the biotech investor looking for a relatively stable investment with moderate growth potential.
Biotech companies that are relatively higher risk, but potentially higher rewardThese micro cap (very small in terms of market valuation) biotechcompanies have products in the late stages of clinical development (either in phase 3 clinical trials or pending review and approval by the FDA) and at least 6 months of cash on hand. These biotech companies have the potential for dramatic growth in valuation if they receive FDA approval or achieve clinical success. We would consider these biotech companies as relatively high risk investments, as negative news will result in marked stock price declines.
Biotech companies selling at or near cashThese are biotech companies that are trading at a very low technology or enterprise values. In other words, biotech companies selling close to their cash levels. Such biotech companies may be viewed as potentially undervalued or perhaps as having low downside risk.
Potentially undervalued biotech companies trading in the bottom half of their 52 week price range with products in late-stage clinical trialsThese are biotech companies that are trading in the lower half of their 52 week range, but have a product either in phase 3development or pending approval by the FDA. These biotech companies also have at least 2 years worth of cash (based on the last quarter's spending and current cash reserves) and a market cap greater than $50 million.
Biotech companies with drugs that are pending FDA approvalBiotechnology companies tend to have increased trading activity around the time that they are awaiting FDA approval for a product. Biotech companieswith promising products tend to trade up in anticipation of these events. By selecting biotech stocks of companies that are awaiting FDA approval, an investor may be able to take advantage of this trading pattern.
Biotech companies with a Phase 3 product and market cap below $250MThese are biotech companies that are small to moderate in size that have a least one product in Phase 3 clinical trials.
Biotech companies with an expected clinical milestone in the next yearAs most biotechnology companies do not have any products on the market or meaningful revenues, company valuations are often driven by news or milestone events. As milestone events approach, such as the announcement of clinical trial results, a company's stock may trade up in anticipation. BiotechWatch provides a search to identify the companies with known milestones that are expected in the next 12 months. As some companies do not publicly announce the timing of all milestone events, this search parameter may have some limitations.
Biotech companies trading within 20% of the 52 week lowOften the performance of a biotech stock is related to its previous trading history. This search looks at a 52 week low values to identify companies that are trading within 20% of that number. Stocks trading within 20% of their 52 week low may be more likely to have upward movement in their value if past performance is any guide.
Biotech companies with a stock price between $0 to $2Investors often want to buy biotech stocks within a certain price range. BiotechWatch provides an easy search to identify biotech stocks trading within specific price ranges ($0 to $2).
Biotech companies with a stock price between $2 to $5Investors often want to buy biotech stocks within a certain price range. BiotechWatch provides an easy search to identify biotech stocks trading within specific price ranges ($2 to $5).
Biotech companies with a stock price between $5 to $10Investors often want to buy biotech stocks within a certain price range. BiotechWatch provides an easy search to identify biotech stocks trading within specific price ranges ($5 to $10).
Biotech companies with a stock price between $10 to $30Investors often want to buy biotech stocks within a certain price range. BiotechWatch provides an easy search to identify biotech stocks trading within specific price ranges ($10 to $30).
Biotech companies with a stock price over $30Investors often want to buy biotech stocks within a certain price range. BiotechWatch provides an easy search to identify biotech stocks trading within specific price ranges (over $30).
Biotech stocks that trade larger volumes or are more liquidBiotech investors often prefer stocks that are easily traded and have comparatively larger volumes of shares traded per day. These are referred to as liquid investments. BiotechWatch provides a search to easily identify companies that trade a minimum of500,000 shares per day. Given the relative illiquidity of some biotechnology stocks, this represents approximately 25% of the companies in the BiotechWatch database.
Micro market cap biotech stocksBiotech investors may prefer to invest in biotech companies that are trading within a specific market capitalization range. In the case of micro market cap biotech companies (under $60 million), expectations may be that a biotech company is undervalued and would have the best chances for large returns with positive news. BiotechWatch's definitions of micro, low, moderate and large market cap values are specific to the biotechnology sector.
Low market cap biotech stocksBiotech investors may prefer to invest in biotech companies that are trading within a specific market capitalization range. Biotech companies with low market caps (between $60 to $200 million), are in the lower tier of companies and have a chance of entering the next tier of biotech companies on positive news. BiotechWatch's definitions of micro, low, moderate and large market cap values are specific to the biotechnology sector.
Moderate market cap biotech stocksBiotech investors may prefer to invest in biotech companies that are trading within a specific market capitalization range. Biotech companies with moderate market caps (between $200 to $500 million), are in the middle tier companies and have a chance of entering the top tiers of biotech companies on positive news. BiotechWatch's definitions of micro, low, moderate and large market cap values are specific to the biotechnology sector.
Large market cap biotech stocksBiotech investors may prefer to invest in biotech companies that are trading within a specific market capitalization range. Biotech companies with large market caps (over $500 million), may be viewed as more stable and investing in these biotech companies allows an investor to participate in the biotechnology while minimizing some of the associated risk.