Berg Pharma LLC, of Boston, began a Phase I trial of compound 31543 for chemotherapy-induced alopecia...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study testing CRLX101 in platinum-resistant ovarian cancer...Results were published online in the Clinical Journal of Pain, ahead of the print edition

The company is partnered with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, and recently expanded the collaboration to develop a second protein therapeutic for an undisclosed orphan disease using Synageva's development capabilities and protein expression platform...The company plans to use the proceeds to complete clinical development of lead candidate dalbavancin, currently in a second pivotal Phase III trial in skin infections, and to fund commercialization activities in the U.S...LLC and CRT

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said Phase IIa ocular safety results published in the American Journal of Ophthalmology showed that CPP-109 (vigabatrin), a GABA aminotransferase inactivator in clinical trials to treat cocaine addiction, did not cause a decrease in visual acuity or significant peripheral visual field changes with short-term use...Isotechnika Pharma Inc., of Edmonton, Alberta, said 3SBio Inc., of Shenyang, China, received approval in China to begin a

The company plans to use the proceeds to fund clinical trials, R&D activities and other corporate programs...Gemmus Pharma Inc., of San Francisco, closed a Series A round to advance its host-targeted treatment for influenza...The company plans to use the proceeds to cover the costs of clinical trials for its product pipeline, including CompleoTRT A bioadhesive intranasal testosterone gel, which is in a Phase III study in hypogonadism, to acquire manufacturing equipment and for other corporate purposes

The pivotal clinical study results were presented during the American Academy of Neurology annual meeting in April 2012. (See BioWorld Today, April 30, 2012

Bristol-Myers Squibb Co., of New York, formed a strategic partnership with Emory University in Atlanta to conduct clinical trials involving the pharma's investigational compounds

e-Therapeutics, of Oxford, UK, said that it has started a first clinical trial evaluating its ETS2101 compound as a treatment for cancer...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...The subject was treated at the clinical site and has fully recovered, the company said

The request echoes that of the American Society of Clinical Oncologists, which called last week for Congress to put some teeth into the drug shortage reporting requirement. (See BioWorld Today, June 5, 2012.) The conference committee is still hopeful that the House and Senate bills can be reconciled and passed by July 4...We feel it is essential that it be understood that this case could potentially adversely impact ours and other industries whose activities are far removed from the clinical

Igenica plans a modest expansion of its work force, currently 29 employees, to enhance its research, preclinical and initial clinical capabilities...Concit Pharma ApS, of Jyderup, Denmark, raised €1.3 million (US$1.63 million) through an investment by SEED Capital and Novo Seeds...AeroVanc is in development for pulmonary methicillin-resistant Staphylococcus aureus infection in cystic fibrosis patients.

Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, reported data from the Phase III PHOENIX study showing that maintenance treatment with Stelara (ustekinumab) for up to five years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis

Finox Biotech AG, of Burgdorf, Switzerland, said its pivotal Phase III study of Afolia, a biosimilar recombinant follicle-stimulating hormone (r-FSH) in patients undergoing assisted reproduction technology met its primary endpoint, demonstrating clinical and statistical equivalence to reference product Gonal-f...Data also showed NeoCart provided significantly greater improvements in a greater number of patients, compared to microfracture, and it is associated with greater clinical efficacy two

The data were presented at the American Association of Clinical Endocrinologists 21st annual Scientific and Clinical Congress

1 percent of patients with moderately to severely active ulcerative colitis who received gut-selective monoclonal antibody vedolizumab experienced clinical response vs. 25.5 percent in the placebo group (p < 0.0001...In the four-week and eight-week maintenance dosing arms, among patients who had responded at week six, 44.8 percent and 41.8 percent, respectively, experienced clinical remission at week 52, compared with 15.9 percent for placebo

Janssen Research & Development, of Raritan, N.J., a unit of Johnson & Johnson, reported findings showing that subcutaneous induction regimens of anti-TNF-alpha therapy Simponi (golimumab) induced clinical response in a majority of patients with moderately to severely active ulcerative colitis who had previously failed or were intolerant to conventional agents...More than 50 percent of patients in each of the two Simponi dosing groups achieved clinical response at week six, the primary endpoint of

The study is expected to enroll 100 patients and will assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22, when administered between 13 days and 19 days post-ischemic event...EP-101 is delivered via the eFlow nebulizer device licensed from PARI Pharma GmbH, of Grafelfing, Germany

In both phases of the trial, induction and maintenance, vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission compared to placebo

Bionor Pharma ASA, of Oslo, Norway, Eurocine Vaccines AB, of Solna, Sweden, and Oslo University Hospital reported that a trial of Bionor Pharma's Vacc-4x and Eurocine Vaccines adjuvant Endocine produced vaccine-related immune responses in a nasal immunization study in human patients...Clinical activity observed included favorable bone marrow responses in high-risk patients who were refractory to hypomethylating agents, a reduction in need for red blood cell (RBC) transfusions in transfusion

The study's primary endpoint was time to treatment failure (defined as discontinuation due to insufficient clinical response or an adverse event, including exacerbation of underlying disease

But when a single patient in the trial developed autoimmune vasculitis, the FDA smacked a clinical hold on the program...But even with a superior product profile, Dynavax will no doubt face an uphill marketing battle against its entrenched big pharma competition...The company had previously hoped to sell 5.77 million shares priced between $12 and $14 apiece. (See BioWorld Today, Nov. 29, 2011.)