Search Results for: Clinical Roundup
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Clinic Roundup
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency to initiate a Phase I study of ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR), in TTR-mediated amyloidosis...ALN-TTRsc is the first GalNAc-siRNA to enter clinical development...The authors based their conclusions on post-hoc analyses of clinical data from a 1,040-patient DNA substudy of ARCA's Phase III Beta-Blocker Evaluation of SurvivalBioWorld Today | Friday, January 4, 2013 -
Financings Roundup
clinical development of the company's lead candidate, perhexiline, for the treatment of heart failure symptoms in patients with hypertrophic cardiomyopathy (HCM), an inherited heart muscle defect that leads to disordered cardiac energy metabolism, enlarged heart muscle, obstructed blood flow from the heart and eventual heart failureBioWorld Today | Friday, January 4, 2013 -
FANG Bites Off $24M Series B; Gradalis Ovarian Trial Advances
Funds from the Series B, which the firm was expected to disclose today, also will be used to progress clinical and preclinical development of its bifunctional short hairpin RNA (shRNA) platform, but it was FANG that loosened the purse strings in the round...acted as exclusive placement agent.By Randy Osborne | BioWorld Today | Thursday, January 3, 2013 -
Financings Roundup
Funds will be used for working capital and for continuation of clinical research and development of Cavatak, an oncolytic virus candidateBioWorld Today | Wednesday, December 26, 2012 -
Clinic Roundup
OMP-52M51 is OncoMed's fifth product candidate to enter clinical development, a proprietary monoclonal antibody that targets the Notch1 receptorBioWorld Today | Wednesday, December 26, 2012 -
Clinic Roundup
Acura intends to complete clinical testing for a new drug submission via the 505(b)(2) pathway in the first half of 2014...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 rescue antibiotics, compared to 78.9 percent of patients receiving vancomycin...About 79.6 achieved clinical cure, compared to 80 percent of the vancomycin groupBioWorld Today | Friday, December 21, 2012 -
HC Royalty Inks Hefty Deals to Propel Nuron and Raptor
As a small biotech with one foot in infectious disease and the other in neurology while having one hand in commercial products and the other in clinical development, "we have a unique strategy, and so far it's working well," Musunuri said...Proceeds will be used for general corporate purposes, including the company's ongoing trials of NX-1207, in late-stage development for benign prostatic hyperplasia and in Phase II testing in prostate cancer.By Marie Powers | BioWorld Today | Friday, December 21, 2012 -
Ampligen Down, Probe Aims at Hemispherx Execs' Moves
Then they heard dozens of patients – many participants in the clinical trials – say they didn't care...The guidance generally applies to submissions of summary 22 level clinical site datasets within new drug applications, biologics license applications and NDA and BLA supplemental applications containing new clinical study reports that are submitted to the Center for Drug Evaluation and ResearchBy Randy Osborne | BioWorld Today | Friday, December 21, 2012 -
Domo 'Regado': $51M to Fund REG1 Phase III in Thrombosis
Arno is conducting clinical and preclinical studies of three drug candidates to treat a variety of cancers...The company intends to use the net proceeds primarily to advance the clinical development of its lead drug candidate, pracinostat, an oral histone deacetylase inhibitor...NeRRe Therapeutics Ltd., of London, raised £11.5 million (US$18.4 million) to develop a portfolio of clinical and preclinical neurokinin receptor antagonists divested from GlaxoSmithKline plc, also of London. #kicker123By Randy Osborne | BioWorld Today | Thursday, December 20, 2012 -
Clinic Roundup
The protocol was crowdsourced, using telemonitoring for patient data collection, and Transparency said it was the first clinical trial protocol developed in such a way...The company is trying to reduce the cost of clinical trials by 50 percent or more, and is partnered with Advanced Monitored Caregiving, a telehealth provider, to that end...Study patients will have in-person visits with the clinical trial staff at the beginning and end of the trial, and all other data will be collected at homeBioWorld Today | Wednesday, December 19, 2012 -
Blend Gets $16M in Series B; Brewing Platinum Nano-Drug
Trevi Therapeutics Inc., of New Haven, Conn., closed a $10 million Series A financing to advance the clinical development of T111 in the lead indication of uremic pruritis...Proceeds are expected to advance T111, an oral, extended-release opioid, into clinical development, with an efficacy study expected to begin in the first quarter of 2014.By Randy Osborne | BioWorld Today | Wednesday, December 19, 2012 -
Clinic Roundup
Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management...The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses...It has been delayed due to the need for further patient recruitment after the approved clinical trial amendment to add an additional 4-g/day CaPre treatment group, following an FDA recommendation to evaluate the effect of a 4-g doseBioWorld Today | Tuesday, December 18, 2012 -
FDA Issues Draft Guidances on Drug Errors, Bioequivalence
As part of a commitment to accelerate drug approval times, the FDA released its draft guidance on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in NDAs and biologics license applications...Deadline for entries is April 15, 2013.By Staff Reports | BioWorld Today | Monday, December 17, 2012 -
Cytori Fattens Coffers: $18.5M for Adipose Stem Cell Efforts
will go toward boosting the Celution System for processing adipose-derived regenerative cells (ADRCs), as well as clinical trials and general corporate purposes, the company said...In Japan, 20 percent of the approved clinical trials using stem cells deploy Cytori products...About 40 clinical trials using Cytori's system are ongoing around the world, not counting those under way by the company itselfBy Randy Osborne | BioWorld Today | Monday, December 17, 2012 -
Clinic Roundup
Spectrum Pharmaceuticals Inc., of Henderson, Nev., presented clinical data at the recent American Society of Hematology meeting in Atlanta for cancer drug Zevalin (yttrium-90-ibritumomab tiuxetan), including results from a Phase II study showing that Zevalin plus BEAM chemotherapy (carmustine, etoposide, cytarabine and melphalan) prior to autologous stem cell transplantation in refractory non-Hodgkin's diffuse large B-cell lymphoma produced a two-year overall survival rate of 65 percent and aBioWorld Today | Friday, December 14, 2012 -
To 'Infinity' and Beyond: $150M to Propel PI3K Inhibitor IPI-145
Data also indicated rapid onset of activity, with clinical activity reported for 16 of 19 responders occurring within the first two cycles of treatment...OncoSec plans to use the proceeds to fund clinical trials and research and development and for other corporate purposes...The company plans to use the proceeds to fund research and development, clinical trials and for other corporate purposes.By Marie Powers | BioWorld Today | Friday, December 14, 2012 -
Clinic Roundup
Data demonstrated that patients with established atrial fibrillation (AF) receiving Gencaro in the trial had improvements in heart failure clinical endpoints, and those receiving Gencaro were more likely to achieve ventricular rate controlBioWorld Today | Thursday, December 13, 2012 -
Financings Roundup
The company plans to use proceeds to expand clinical development of its dismutase mimetics, small-molecule mimics of critical enzymes in the oxygen metabolic pathways designed to overcome limitations of prior approaches to controlling superoxide and its harmful roles in human diseaseBioWorld Today | Wednesday, December 12, 2012 -
Clinic Roundup
Sarepta Therapeutics Inc., of Cambridge, Mass., said updated data from Study 202, its open-label, Phase IIb extension study of eteplirsen for the treatment of Duchenne's muscular dystrophy, showed that patients treated with eteplirsen for 62 weeks and evaluable on ambulatory measures (modified intent-to-treat population) maintained a statistically significant clinical benefit on the primary clinical outcome measure, the six-minute walk test, compared to patients who received placebo for 24 weeksBioWorld Today | Monday, December 10, 2012 -
Clinic Roundup
The study is being conducted at 76 clinical sites in the USA, Canada, Europe and Australia...with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases...Dompe Group, of Milan, Italy, said it presented the status of a clinical trial to evaluate the safety and pharmacokinetic profile of Reparixin, administered orally in combination with paclitaxel in women with metastatic breast cancer at the San Antonio Breast Cancer SymposiumBioWorld Today | Friday, December 7, 2012
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