Hyperion Therapeutics Inc., of South San Francisco, said population pharmacokinetic (PK) modeling and dosing simulations from Ravicti (glycerol phenylbutyrate) and Buphenyl (sodium phenylbutyrate) were reported in The Journal of Clinical Pharmacology based on data from four Phase II and III trials that enrolled patients with urea cycle disorders (UCDs

The combination has demonstrated early signals of activity with a disease control rate (complete response, partial response, minimal response or stable disease) of 82 percent and a clinical benefit rate (>/= minimal response) of 53 percent, including one complete response...In a single-agent Phase II ARRY-520 clinical study, the median overall survival was reported to be markedly longer in patients with low AAG as compared to patients with high AAG (20.2 vs. 4.5 months...Incyte Corp., of Wilmington

and Regado Biosciences Inc. – prepared to price IPOs this week, a fourth, Onconova Therapeutics Inc., filed a registration statement with the SEC, seeking to raise up to $75 million. (See BioWorld Today, May 1, 2013, May 17, 2013, and May 20, 2013.) Onconova filed its S-1 Friday evening after the market's close, hours after a similar filing by Conatus Pharmaceuticals Inc. (See BioWorld Today, June 17, 2013.) In its S-1, Onconova said it plans to use the proceeds to fund the clinical

Of 15 heavily treated intermediate or high-risk patients with myelodysplastic syndrome, six achieved a clinical response with a median duration of 92 days...The company said the updated results showed promise for clinical activity of the drugs in heavily pretreated MDS patients and confirmed demethylation activity of the medicine

Astex Pharmaceuticals Inc., of Dublin, Calif., presented updated clinical results of its hypomethylating agent, SGI-110, in a poster session at the 18th Congress of the European Hematology Association in Stockholm, Sweden...The update focused on details of the biological and clinical activity as well as safety in the group of intermediate or high-risk relapsed or refractory myelodysplastic syndromes patients treated in the dose-escalation, Phase I part of the SGI-110-01 study...Of the 15 patients, six

Apceth GmbH, of Munich, Germany, received approval to conduct a clinical cancer trial with its genetically modified adult mesenchymal stem cells...At every evaluation point, no statistical differences were observed through evaluations by time points and in all clinical domains...Incyte Corp., of Wilmington, Del., and Eli Lilly and Co., of Indianapolis, said an open-label, long-term extension of a Phase IIb (JADA) study of baricitinib in patients with active rheumatoid arthritis showed that clinical

Genmab A/S, of Copenhagen, Denmark, said teprotumumab (RG1507), an antibody developed by Genmab under a collaboration with Roche AG, of Basel, Switzerland, will restart clinical development in a Phase II study in patients with active thyroid eye disease...Clinical development will be conducted by River Vision Development Corp., which licensed teprotumumab from Roche...The company recently launched the Crohn's disease clinical trial and is actively recruiting participants with moderate to severe

The study demonstrated the superiority of ozenoxacin 1 percent cream, applied topically for five days, compared to placebo on both clinical and bacteriological endpoints by end-of-therapy visit (day six to seven

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

The study, initiated in July 2012, enrolled a total of 77 patients in clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon

Vanda Pharmaceuticals Inc., of Washington, presented additional entrainment and patient-level clinical data at SLEEP 2013, the meeting of Associated Professional Sleep Societies in Baltimore, from its SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat non-24-hour disorder) Phase III studies of tasimelteon, a circadian regulator...In the SET study, tasimelteon achieved the primary endpoints of entrainment (synchronizing

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

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 Clinical Global Impression-Change (CGI-C) rating, a subjective physician-completed overall improvement scale, showed that at one and two weeks of treatment, 88 percent and 76 percent of subjects improved on N05 vs. 27 percent and 39 percent, respectively, on placebo (p < 0.001, p = 0.0016, respectively...No safety concerns relating to any of the aforementioned products have been identified in any preclinical and clinical data generated to date and there is no reason to believe that the

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