Search Results for: Clinical Roundup
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Clinic Roundup
CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion...The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining ofBioWorld Today | Tuesday, May 7, 2013 -
Arrowhead Bolsters Balance Sheet, Adds $36M for Pipeline
shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infection...Shares of Supernus (NASDAQ:SUPN) lost 3 cents Monday to close at $5.12.By Jennifer Boggs | BioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
clinical trials where a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugsBioWorld Today | Monday, May 6, 2013 -
Galapagos Lands $71M from Stoked U.S. Investors
The first clinical trials of the drug, GLPG1790, are expected to start within the next year...On Friday, the company's NASDAQ-listed American depository shares (NASDAQ:PRAN) gained 1 cent, closing at $2.27.By Nuala Moran | BioWorld Today | Monday, May 6, 2013 -
Arena Yanks MAA, Falls on Belviq Launch Delay in U.S.
The drug was included in a recent diabetes management report from the American Association of Clinical EndocrinologistsBy Jennifer Boggs | BioWorld Today | Monday, May 6, 2013 -
Clinic Roundup
Ltd., of Germantown, Md., said it filed an investigational new drug application (IND) to begin clinical trials of its adipose-derived stem cell product, RNL-JointStem, for the treatment of osteoarthritis...Seaside Therapeutics Inc., of Cambridge, Mass., said its Phase IIb trial evaluating arbaclofen (STX209) in core impairments of autism spectrum disorder (ASD) failed to show improvement on the primary endpoint of social withdrawal but demonstrated improvement on the clinical global impression ofBioWorld Today | Friday, May 3, 2013 -
Celator Pharmaceuticals Raises $32.5M for Phase III AML Trial
The trial, which will enroll 300 patients, is based on results from a Phase IIb study in newly diagnosed AML patients, 60-75, presented at the American Society of Clinical Oncology conference in 2011...The exercise of the overallotment option brings the total gross proceeds from the offering to $10.75 million. (See BioWorld Today, May 1, 2013.)By Staff Reports | BioWorld Today | Thursday, May 2, 2013 -
Clinic Roundup
The open-label trial will randomize 20 postmenopausal women with estrogen receptor-positive disease who have responded previously to hormone therapy to receive 9 mg of enobosarm once daily until they show clinical progression or have completed 336 days of treatment...The primary endpoint is clinical benefit, which will be assessed at six months...RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it started clinical development of an autologous cell therapy for the treatment of aBioWorld Today | Wednesday, May 1, 2013 -
Phase III-Ready Anticoagulant Awaits Cash from Regado IPO
Scioderm is advancing SD-101, a topical cream with a unique mechanism of action, into clinical development in epidermolysis bullosa (EB), a rare genetic condition that results in extremely fragile skin that blisters and tears easily...In an open-label Phase II study conducted in children with simplex, recessive dystrophic EB or junctional EB, SD-101 application resulted in complete closure of 88 percent of target chronic lesions within one month.By Randy Osborne | BioWorld Today | Wednesday, May 1, 2013 -
ECCMID Roundup
The following data were reported from European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Berlin...Trius Therapeutics Inc., of San Diego, announced a range of clinical data for the experimental antibiotic tedizolid phosphate (TR-701) and a presentation on linezolid-resistant strain of bacteria...The results of a separate clinical cardiovascular safety study showed that tedizolid was not associated with heart beat abnormalities at up to six times its effective doseBioWorld Today | Tuesday, April 30, 2013 -
Clinic Roundup
Chimerix Inc., of Durham, N.C., presented the first clinical outcomes data on lead candidate CMX001 in life-threatening infection with adenovirus (AdV), a disease with no approved therapyBioWorld Today | Tuesday, April 30, 2013 -
Epizyme Files for IPO, Aims for $69M for Epigenetics Platform
The company filed to go public earlier this month, aiming to raise $86.3 million to support clinical work in multiple sclerosis, inflammatory bowel disease and allergic/immune-mediated disorders...The funding allowed ReXceptor to enter a formal partnership with C2N Diagnostics, which will assist the company with the initiation and coordination of the clinical trial of an AD program licensed from Case Western's Technology Transfer Office and based on discoveries that bexarotene, a medication sold atBy Jennifer Boggs | BioWorld Today | Monday, April 29, 2013 -
Alzheimer's Continues to Get Short End of the Budget Stick
The NIH has helped fund two clinical trials – one that's testing an insulin nasal spray to treat patients with Alzheimer's and a prevention trial in people at the highest risk of the disease. (See BioWorld Today, May 16, 2012.) Other projects include whole genome sequencing to identify new genetic variants that increase or reduce the risk of the disease, new stem cell methods, tools to improve care and steps to address inappropriate use of drugs to treat behavioral symptoms, Donald MouldsBy Mari Serebrov | BioWorld Today | Friday, April 26, 2013 -
CBO: Key to Innovation is Making it a National Priority
When it comes to biopharma, the development cost for one drug can be hundreds of millions of dollars, depending on the number and size of clinical trials the FDA requires...We would like to see CMS use any flexibility that exists to implement the cuts in such a way that the core mission of the agency – to provide care to beneficiaries – is retained and protected," the lawmakers said in a recent letter to CMS.By Mari Serebrov | BioWorld Today | Thursday, April 25, 2013 -
Clinic Roundup
Cel-Sci Corp., of Vienna, Va., entered a co-development agreement with Ergomed, a clinical research organization (CRO), to expand its Phase III study of Multikine (leukocyte interleukin) as an injectable treatment for head and neck cancer...Under the agreement, Ergomed will contribute up to $10 million toward the study, for which it will perform clinical services in exchange for a single digit percentage of milestone and royalty payments, up to an undisclosed specified amountBioWorld Today | Wednesday, April 24, 2013 -
Clinic Roundup
The primary objectives include the evaluation of adverse events and a six-month clinical responseBioWorld Today | Tuesday, April 23, 2013 -
Clinic Roundup
Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the Journal of Nuclear Medicine published the results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementiaBioWorld Today | Monday, April 22, 2013 -
ActoGeniX Series B to Move IBD Program to IND Stage
AG014 comprises oral delivery of an anti-TNF antibody with proven clinical efficacy in IBD, resulting in local efficacy and an improved safety profile over systemic drugs...Shares of Northwest (NASDAQ:NWBO) fell 13 cents to close Thursday at $3.77.By Marie Powers | BioWorld Today | Friday, April 19, 2013 -
Clinic Roundup
Alkermes Inc., of Dublin, Ireland, said top-line data from a Phase II study showed that ALKS 5461, a drug in development to treat patients who have an inadequate response to standard therapies for clinical depression, significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measure, the Hamilton Depression Rating Scale (p = 0.026), the Montgomery-Asberg Depression Scale (p = 0.004) and the Clinical Global Impression-Severity Scale (pBioWorld Today | Thursday, April 18, 2013 -
Auris Medical Gets $51M for Hearing Disorder Drugs
Proceeds will be used to advance its gene therapy product for congestive heart failure into clinical development...BofA Merrill Lynch, Barclays and Leerink Swann acted as joint book-running managers, while Stifel and Piper Jaffray served as co-managers. (See BioWorld Today, April 2, 2013.)By Cormac Sheridan | BioWorld Today | Wednesday, April 17, 2013
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