BHR Pharma LLC, of Herndon, Va., said the European Medicines Agency (EMA) granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its intravenous progesterone infusion agent, BHR-100...Patients receiving either 1,000-mg or 2,000-mg daily doses of GTx-758 demonstrated significant reductions in their serum-free (unbound) testosterone levels, with related reductions in their levels of serum prostatic specific antigen

Cerulean Pharma Inc., of Cambridge, Mass., said CRLX101 achieved the predefined gating criterion for advancement into the second stage of a Phase II trial in advanced ovarian cancer...All patients receiving DPX-Survivac also demonstrated antigen-specific immune responses, as measured by at least one of the study's three immune monitoring assays

Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study of lead candidate CRLX101 in advanced gastric cancer...Patients receiving Tolenix, a twice-daily combination of muscarinic antagonist tolterodine and muscarinic agonist pilocarpine, exhibited no safety issues and also demonstrated statistically significant and clinically meaningful improvements in their saliva production and dry mouth side effects, as compared to Detrol

BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the efficacy of Livatag (doxorubicin Transdrug) in primary liver cancer and recommended continuing the global, multicenter, randomized study without modification. (See BioWorld International, June 29, 2011...Data showed that 82.3 percent of patients who received oritavancin met the early clinical endpoint of cessation of spread, absence of fever and no

Immunomedics Inc., of Morris Plains, N.J., said patients receiving epratuzumab reported clinically meaningful improvements in health-related quality of life (HRQoL) that were sustained over about four years of treatment...Tiltan Pharma Ltd., of Jerusalem, said it enrolled the first U.S

Investigators said 47 percent of patients receiving Simponi 50 mg and 51 percent of patients receiving Simponi 100 mg maintained clinical response through week 54 compared with 31 percent of patients on placebo (p = 0.01 and p < 0.001, respectively...Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

AlphaCore Pharma Inc., of Ann Arbor, Mich., said its Phase I trial met the primary endpoint by demonstrating the safety and tolerability of ACP-501 (recombinant human LCAT...The positive clinical effects of the twice-daily dose of the drug relative to placebo were observed in a variety of standard psoriasis assessment parameters, with the responses accumulating over the 24 weeks...Sophiris Bio Inc., of La Jolla, Calif., released top-line data from the 12-month follow-up of patients receiving PRX302

Clavis Pharma ASA, of Oslo, Norway, said its partner Clovis Oncology Inc., of Boulder, Colo., initiated a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC...Patients receiving the naloxone spray achieved the study's primary endpoint with a statistically significant reduction in time spent per week binge eating compared with patients on placebo

Cerulean Pharma Inc., of Cambridge, Mass., completed enrollment in a Phase II trial of CRLX101, in non-small-cell lung cancer (NSCLC) and dosed its first patient in a Phase Ib/IIa trial of the same product in combination with Avastin (bevacizumab, Roche AG) in metastatic renal cell carcinoma (mRCC...Protalix BioTherapeutics Inc., of Carmiel, Israel, reported clinical data for taliglucerase alfa showing that at 36 months, patients with Gaucher disease had significant improvement in bone marrow fat

Patients receiving lorcaserin lost 4.5 percent to 5 percent of their initial body weight, compared to 1.5 percent for those on placebo...Isotechnika Pharma Inc., of Edmonton, Alberta, said 3SBio Inc., of Shenyang, China, received approval in China to begin a Phase III trial of voclosporin

Treatment involved the patient receiving five injections in the cervical (upper back) region of the spinal cord, in addition to the 10 he received previously in the lumbar region of the spine, for a total of 15 injections...Noxxon Pharma AG, of Berlin, has treated the first patient in a Phase IIa trial of its anti-CCL2/MCP-1 Spiegelmer NOX-E36 in patients with diabetic nephropathy

Antisense Pharma GmbH, of Regensburg, Germany presented complete data from its Phase I/II study of trabedersen, an antisense compound that specifically inhibits expression of transforming growth factor beta 2 (TGF-β2) – a protein which is overexpressed in advanced tumors – in patients with advanced pancreatic cancer, malignant melanoma or colorectal cancer...Of the 89 evaluable patients, the objective response rates were 73 percent for patients receiving combination therapy, with 36 percent

Clavis Pharma ASA, of Oslo, Norway, said Deerfield, Ill.-based Baxter International Inc...has released its first batch of elacytarabine for clinical use...Secondary endpoint analysis showed superior rates of sustained clinical response 25 days after the end of treatment, and lower recurrence rates within four weeks of treatment

It's a great fit with clinical need and best suited to deal with the three major factors associated with myelofibrosis...Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported clinical data from a number of programs...Astellas Pharma Inc., of Tokyo, and Ambit Biosciences Corp., of San Diego, shared updated results from an interim analysis of a Phase II trial of quizartinib (previously AC220) in acute myeloid leukemia, showing that quizartinib monotherapy had activity in refractory and relapsed

Clavis Pharma ASA, of Oslo, Norway, reported interim efficacy data from a Phase II trial showing that elacytarabine in combination with idarubicin produced a complete remission rate in about 46 percent (12 of 26) of patients with early stage acute myeloid leukemia who had failed cytarabine-containing first-course chemotherapy...Patients receiving edoxaban had a lower incidence of a composite of deep-vein thrombosis and pulmonary embolism than those treated with enoxaparin (5.1 percent vs. 10.7

Galderma Pharma SA, of Lausanne, Switzerland, reported top-line results from a Phase IIb trial showing that CD07805/47, a topical gel in development for moderate to severe facial erythema of rosacea, was rapidly effective at reducing facial redness...Inc., of Whitehouse Station, N.J., said results from a 24-week interim analysis of a 48-week Phase IIb study showed that 70.5 percent of patients (43/61) receiving its protease inhibitor Victrelis (boceprevir) in combination with peginterferon alfa and

The findings were based on Kohl's correspondence with six big pharma companies and an inquiry into URL Pharma Inc.'s pricing of its gout drug Colcrys (colchicine) and Avarin Pharmaceuticals Inc.'s pricing of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), the first approved treatment for pseudobulbar affect. (See BioWorld Today, June 3, 2011.) In a letter to the pharma companies, which included AstraZeneca plc and Eli Lilly and Co., Kohl asked why "Americans pay, on average

The drug was previously included as part of a six-year option agreement with GlaxoSmithKline plc, but the big pharma passed on the compound in 2008...The South San Francisco-based firm raised $165 million a few months later to push cabozantinib through clinical trials. (See BioWorld Today, Dec. 6, 2010, and March 11, 2011.) The results of initial trials seemed to garner mixed feedback at ASCO...Astellas Pharma Global Development Inc., of Deerfield, Ill., said AGS-1C4D4 reduced tumor formation and