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...



Site Map