Meanwhile, Gary Burgess, senior vice president of clinical research and chief medical officer, joined Conatus in 2011 from Pfizer, where he oversaw the assimilation of Idun, including data integration, clinical oversight of ongoing Phase II studies, development of clinical plans and registration strategies for emricasan...In all, emricasan has completed nine clinical studies, including some at Pfizer, enrolling more than 500 participants, according to Conatus

The new language makes it clear that "sponsors may have to demonstrate clinical superiority to obtain orphan-drug exclusivity even if they did not have to submit a plausible hypothesis of clinical superiority to obtain...Comments on the list and proposed rule are due by Aug. 12.

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...The offering is expected to close on June 17.

Shares of Clovis (NASDAQ:CLVS), which jumped 100 percent earlier this month on data presented at the American Society of Clinical Oncology meeting in Chicago, closed Monday at $73.15, up $1.32. (See BioWorld Today, June 4, 2013

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...In May, it inked an extension to its deal with Galapagos NV to extend the clinical development of oral JAK1 inhibitor GLPG0543 into Crohn's disease...Exploratory endpoints in the study are looking for clinical efficacy and inflammation biomarkers

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

Funds will support the launch of bowel drug Linzess (linaclotide) in the U.S., and fund development to strengthen the clinical profile of Linzess and expand the product label...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

The National Institute of Allergy and Infectious Diseases awarded Duke University $2 million to initiate a clinical research network focused on antibacterial resistance...The group is expected to conduct early stage clinical evaluation of new antibacterial drugs and trials of approved antibacterials to reduce the risk of resistance

The following data were presented at the American Society of Clinical Oncology meeting in Chicago

The financing is expected to fund the lead program to clinical proof of concept for at least one hearing disorder indication. (See BioWorld Today, Aug. 23, 2011

Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent

But this time, they'll be listening to a version conducted by the Duke Clinical Research Institute (DCRI), which was hired by GSK to satisfy the FDA's 2010 demand for an independent readjudication of the CV safety results from the unblinded trial as a condition for allowing the drug to remain on the market for a restricted group of patients...The committees also will discuss how the readjudicated data should be weighed in the overall consideration of CV risk with Avandia and whether additional

The draft reflects changes in the standard of care that have occurred over the past 15 years and provides guidance on clinical trial design...It addresses such areas as limiting the use of a placebo, using an active comparator for safety and efficacy trials, designing dosing regimens, establishing efficacy, developing drug-device combination products and using efficacy endpoints such as clinical remission and prevention of structural damage progression...The agency will accept comments on the draft

Prosensa, based in Leiden, the Netherlands, has methodically moved two exon-skipping antisense oligonucleotide drugs into clinical development in Duchenne's muscular dystrophy (DMD) and has three preclinical assets lined up behind them...Although the parent company's Microcyn wound care technology has been widely studied and translated into multiple products, the new formulation will require a full complement of clinical studies, he said...Since we're not going to have clinical data at the time we

The government does not match the experience, expertise, clinical knowledge and infrastructure that an ExpressScripts or UnitedHealthcare brings to the negotiating table," he continued...News of the ruling boosted PharmAthene shares (NYSE Amex:PIP), which closed at $2.03 Tuesday, up 43 cents, or 27 percent.

The San Francisco-based company said proceeds, raised exclusively from existing shareholders and partner companies, will advance the clinical development of Pexa-Vec in HCC and in the follow-on indication of refractory colorectal cancer...The company said proceeds will be used for general corporate purposes, including clinical trial expenses and additional regulatory efforts related to erectile dysfunction drug Vitaros (alprostadil 0.3 percent topical cream) and female sexual dysfunction candidate

Net proceeds will support the launch of Linzess (linaclotide) in the U.S., and fund development to strengthen the clinical profile of Linzess and expand the product label...The company's platform technology is designed to improve drug delivery into internal body cavities.

959, biologics may only be compounded from an approved biologic for a patient for whom the drug produces a clinical benefit, upon receipt of a prescription or medical order...A Medicare beneficiary pays an average cost of $11 for one treatment of compounded bevacizumab compared with about $400 per dose of the approved AMD drugs, the group said. (See BioWorld Today, March 26, 2013.)

Funds will be used to support ongoing and new clinical trials and development and commercialization of Parkinson's psychosis drug pimavanserin and for general corporate purposes...and to fund linaclotide development opportunities to strengthen the clinical profile of Linzess and expand the product label for additional populations and indications...Net proceeds are expected to total about $37.7 million and will be used to fund clinical trials of SFP, an iron compound for hemodialysis patients, and for