Search Results for: Clinical Roundup
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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 at -
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 Moulds -
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. -
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 amount -
Clinic Roundup
The primary objectives include the evaluation of adverse events and a six-month clinical response -
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 dementia -
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. -
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 (p -
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.) -
Clinic Roundup
clinical trials, for SMD and dry age-related macular degeneration (dry AMD...BHR Pharma LLC, of Herndon, Va., said the 1,000th patient has been enrolled in its SyNAPSe clinical trial, a global Phase III study evaluating the effectiveness of its intravenous progesterone infusion agent, BHR-100, to treat severe traumatic brain injury (TBI...NeuroDerm Ltd., of Ness Ziona, Israel, said enrollment of patients is ongoing in its Phase IIa clinical trial of ND0612, a treatment for Parkinson's disease -
Financings Roundup
Coronado plans to use the proceeds to fund R&D, clinical trials and manufacture of supply as well as other corporate purposes -
AACR Roundup
The study was carried out to explore previous clinical findings with cabozantinib in castration-resistant prostate cancer patients with bone metastases showing a 67 percent rate of bone scan response and other clinical signs of effect -
Clinic Roundup
Regentis raised $10 million last year in a Series C financing to support clinical studies and commercial launch of GelrinC in Europe. (See BioWorld Today, May 15, 2012 -
Clinic Roundup
RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated...The study, designated TRIG-05, is set to start enrollment this month, with a primary clinical endpoint of demonstrating efficacy, tolerability and safety...Viralytics Ltd., of Sydney, Australia, said it finalized the clinical study report on the Phase I evaluation of Cavatak, administered intravenously to late-stage melanoma, prostate, breast or colorectal cancer patients, with results showing that -
MedDay Raises $10.5M for Neurological Drug R&D
The company's "exceptional team" and its potential to obtain rapid clinical efficacy data were two attractive attributes, Rafaèle Tordjman, managing partner at Sofinnova Partners, told BioWorld Today...The company plans to use the funds to move its lead program into clinical trials and to advance a second discovery program...On Tuesday, shares of StemCells (NASDAQ:STEM) gained 7 cents, closing at $1.68. -
Financings Roundup
Canbex, a spinout of University College London, has said it expects to start clinical testing this year -
Clinic Roundup
The primary endpoint of the study is the induction of clinical remission at week 12...The study is being conducted by more than 60 clinical investigators worldwide, including about 11 sites in Brazil and 24 sites in India...The TRIG-05 study is expected to begin enrollment this month, with a primary clinical endpoint of demonstrating efficacy, tolerability and safety of TI-001 -
IPO Flurry Continues: Receptos Files Proposed $86M Offering
biotech to file for an initial public offering (IPO) this year, taking advantage of the emerging growth company provision in the Jumpstart Our Business Start-ups Act and aiming to raise as much as $86.3 million to support clinical work in multiple sclerosis, inflammatory bowel disease (IBD) and allergic/immune-mediate disorders...Funds will be used to progress the clinical development program for lead candidate, Pracinostat, its oral histone deacetylase inhibitor for advanced hematologic -
Clinic Roundup
Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate -
Financings Roundup
Net proceeds will be used to cover costs related to the new drug application for CompleoTRT, making a milestone payment for CompleoTRT, manufacturing scale-up for CompleoTRT and Tefina clinical trials
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