The company recently launched the Crohn's disease clinical trial and is actively recruiting participants with moderate to severe disease

The compound is currently undergoing early stage clinical trials for the treatment of leukemia and solid tumor cancer, with rights to all oncology applications licensed to its partner, Eisai Co...And although full terms of the Series C funding round were not disclosed, they did include the hitting of milestones on the fibrosis clinical trial, according to PRISM Pharma CFO, Dai Takehara

Schaffer said that the criteria for what constitutes a new delivery method that warrants its own safety and biodistribution data "are currently being decided at the FDA level," but that the general assumption is that in the majority of cases, vectors produced by directed evolution will need their own dataset before they are admitted into clinical trials

Significantly, the same NDA dossier was used in both submissions, a milestone in the path toward clinical trial regulatory harmonization, much sought after by both Taiwanese drugmakers and global pharmaceutical companies as an easier regulatory entryway into the enormous China market...P1101 is also undergoing clinical trials for treatment of polycythemia vera, a condition when the bone marrow makes too many red blood cells, leading to CV complications such as strokes

These efforts may have yielded valuable data from clinical trials or drug registration applications

Proceeds will be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories for marketing AAT product Glassia and for general corporate purposes

Agios expects to begin clinical trials by the middle of 2013 for its IDH2 candidate, AG-221, and in early 2014 for its IDH1 candidate, AG-120...Agios has said it may also be possible to use metabolites as biomarkers eventually for purposes such as identifying appropriate patients for clinical trials

The difficulty comes in the fact that, generally, patients enroll in a clinical trial in the hope of getting access to a new or improved therapy...Momenta, of Cambridge, Mass., would like to avoid the recruitment competition of large clinical trials in its development of up to six biosimilars partnered with Baxter International Inc

China, for example, has a plan "definitely" moving ahead to introduce a fast-track approval process for new drugs that could exclude firms that have not conducted clinical trials in the country, Das told BioWorld Today

First published in 2000 by an international collaboration including the European Organization for Research and Treatment of Cancer, the National Cancer Institute and the National Cancer Institute of Canada Clinical Trials Group, and updated in 2009, the RECIST criteria are used in the majority of clinical trials. (See BioWorld Today, Jan. 27, 2009.) Bringing Progress RECIST clearly brought progress to cancer trials, not least by just introducing standardized criteria at all

These efforts may have yielded valuable data from clinical trials or drug registration applications

With data from the first clinical trial of anti-TNF polyclonal antibody AVX-470 in ulcerative colitis (UC) due toward the end of this year, Avaxia Biologics Inc

It will use the proceeds to identify clinical-stage drugs that might have activity against LAM and to begin clinical trials

As part of its development strategy to use its China resources, in January EntreMed submitted a new drug clinical trial application with the Chinese Food and Drug Administration (CFDA) for ENMD-2076 in triple-negative breast cancer...Patent Protection in China 'Essential' As a second prong to its China strategy, EntreMed is considering in-licensing compounds to build a portfolio of oncology drugs that can be moved through clinical trials and commercialized in China

Proceeds will be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories for marketing AAT product Glassia and for general corporate purposes

Significantly, the same NDA dossier was used in both submissions, a milestone in the path toward clinical trial regulatory harmonization, much sought after by both Taiwanese drugmakers and global pharmaceutical companies as an easier regulatory entryway into the enormous China market...P1101 is also undergoing clinical trials for treatment of polycythemia vera, a condition when the bone marrow makes too many red blood cells, leading to CV complications such as strokes

Morphosys currently has more than 70 development programs under way, about 20 of which are undergoing clinical trials

Nordic applied using a centralized procedure, with supporting data from clinical trials in more than 3,400 people