Search Results for: Clinical Roundup
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Jennerex Plucks $21.6M Private Placement; Is IPO Up Next?
The San Francisco-based company said proceeds, raised exclusively from existing shareholders and partner companies, will advance the clinical development of Pexa-Vec in HCC and in the follow-on indication of refractory colorectal cancer...The company said proceeds will be used for general corporate purposes, including clinical trial expenses and additional regulatory efforts related to erectile dysfunction drug Vitaros (alprostadil 0.3 percent topical cream) and female sexual dysfunction candidateBy Marie Powers | BioWorld Today | Friday, May 24, 2013 -
Pharma: Clinic Roundup
Results of the PROLASTIN-C SPARK study, a multidose pharmacokinetic clinical trial, were presented at the annual meeting of the American Thoracic Society in PhiladelphiaBioWorld Today | Thursday, May 23, 2013 -
Clinic Roundup
The study is being sponsored by the Alliance for Clinical Trials in Oncology, a cooperative group of the National Cancer Institute (NCI...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies...Promedior Inc., of Lexington, Mass., presented data from a clinical study of PRM-151 at the American Thoracic Society Conference in PhiladelphiaBioWorld Today | Thursday, May 23, 2013 -
IPOpalooza Continues with Portola's $122M Offering
Net proceeds will support the launch of Linzess (linaclotide) in the U.S., and fund development to strengthen the clinical profile of Linzess and expand the product label...The company's platform technology is designed to improve drug delivery into internal body cavities.By Catherine Shaffer | BioWorld Today | Thursday, May 23, 2013 -
More Transparency Hasn't Translated into Import Safety
959, biologics may only be compounded from an approved biologic for a patient for whom the drug produces a clinical benefit, upon receipt of a prescription or medical order...A Medicare beneficiary pays an average cost of $11 for one treatment of compounded bevacizumab compared with about $400 per dose of the approved AMD drugs, the group said. (See BioWorld Today, March 26, 2013.)By Mari Serebrov | BioWorld Today | Thursday, May 23, 2013 -
Financings Roundup
Funds will be used to support ongoing and new clinical trials and development and commercialization of Parkinson's psychosis drug pimavanserin and for general corporate purposes...and to fund linaclotide development opportunities to strengthen the clinical profile of Linzess and expand the product label for additional populations and indications...Net proceeds are expected to total about $37.7 million and will be used to fund clinical trials of SFP, an iron compound for hemodialysis patients, and forBioWorld Today | Wednesday, May 22, 2013 -
Clinic Roundup
Clinical improvements were seen in all patients with reductions in median stool frequency from 23 to 14 per week (p = 0.03) and an improvement in the median Bristol Stool Form Scale assessing stool type from 5.515 to 4.34 (p = 0.05...Marina Biotech Inc., of Bothell, Wash., said licensee Mirna Therapeutics Inc., of Austin, Texas, has begun a Phase I study of MRX34, the first miRNA to advance into a human clinical trial for cancer...Interim data from that study were reported earlier and full data areBioWorld Today | Tuesday, May 21, 2013 -
Pharma: Clinic Roundup
SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy...The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is being conducted at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in ClevelandBioWorld Today | Tuesday, May 21, 2013 -
As Markets Fancy Biotech, PTC Therapeutics Joins IPO Queue
In its filing, the company said it plans to use proceeds from the IPO to fund the clinical development of lead candidate ataluren (formerly PTC124) in Duchenne's muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF), to seek marketing approval of ataluren in the indications in the U.S...On Friday, the Vetex's shares (NASDAQ:VRTX) gained $1.60, closing at $79.49.By Marie Powers | BioWorld Today | Monday, May 20, 2013 -
Tokai Adds $35.5M in Series E, Preps for Phase III CRPC Trials
Proceeds will be used to fund ongoing and new clinical trials and development and commercialization efforts for pimavanserin, as well as activities for other product candidates and for general corporate purposes...Those personalized and targeted immunotherapies are aimed at providing significant and durable clinical benefit regardless of tumor origin, disease stage and prior treatments. (See BioWorld Today, Oct. 17, 2012...Receptos will use the proceeds to support clinical work in multiple sclerosisBy Jennifer Boggs | BioWorld Today | Thursday, May 16, 2013 -
Clinic Roundup
The PROCEED (PROve Clinical Efficacy and Effect of Delafloxacin) study is designed to test delafloxacin 300 mg, given intravenously every 12 hours, compared to vancomycin 15 mg/kg plus aztreonam 2 g I.V., also given every 12 hours...The study includes clinical and microbiological endpoints to assess the efficacy...Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II results published in the Journal of Clinical Oncology showed that HDAC inhibitor entinostat extended both progression-freeBioWorld Today | Wednesday, May 15, 2013 -
Washington Roundup
With an eye on streamlining the review of clinical trials with low biosafety risks, the National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid moleculesBioWorld Today | Wednesday, May 15, 2013 -
Financings Roundup
Funds will be used for general corporate purposes, including expenses related to the potential commercialization of OMS302 for intraocular lens replacement, as well as for R&D expenses such as funding planned clinical trials for its OMS103HP, PDE10, MASP-2 and PDE7 programsBioWorld Today | Wednesday, May 15, 2013 -
Clinic Roundup
Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancerBioWorld Today | Tuesday, May 14, 2013 -
Beyond Kalbitor: Dyax Adds $30M for HAE Prophylactic
is more than doubling its cash position with a $30 million registered direct offering, with proceeds to fund R&D activities, namely clinical development of DX-2930, a drug slated to start clinical development for prophylactic use in hereditary angioedema (HAE...Shares of the company (NASDAQ:MNOV) gained 58 cents, or 16.5 percent, to close Monday at $4.10.By Jennifer Boggs | BioWorld Today | Tuesday, May 14, 2013 -
Financings Roundup
Net proceeds are expected to total about $16.1 million and will be used for general corporate purposes, including expenses related to the potential commercialization of OMS302 for intraocular lens replacement, as well as for R&D expenses such as clinical trials of its OMS103HP, PDE10, MASP-2 and PDE7 programsBioWorld Today | Monday, May 13, 2013 -
Pharma: Clinic Roundup
Eisai Inc., of Woodcliff Lake, N.J., said antiepileptic drug Fycompa (perampanel) showed a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to two new analyses of early clinical experienceBioWorld Today | Friday, May 10, 2013 -
Isis Peers Beyond Kynamro, Seeks $171M for Pipeline
clinical development plan and financial terms relating to ISIS-TTRRx to reflect an accelerated development plan for that antisense drug...Isis has 28 candidates in preclinical and clinical development across a wide variety of indications, with nine scheduled to report data in the next 12 monthsBy Marie Powers | BioWorld Today | Friday, May 10, 2013 -
Receptos Prices Solid IPO, Raises $72.8M for Pipeline
The funds will support clinical work in multiple sclerosis (MS), inflammatory bowel disease (IBD) and allergic/immune-mediated disorders. (See BioWorld Today, April 8, 2013.) The pricing hits pretty close to the $86.3 million target set when the company filed for its offering only a month ago...Chardan Capital Markets LLC acted as exclusive placement agent for the offering.By Catherine Shaffer | BioWorld Today | Friday, May 10, 2013 -
Committee Looks for the Bright Line in Compounding
There may be value in discussing the benefit-risk framework at end-of-Phase II meetings, in order to ensure alignment on identified and potential risks and benefits, critical efficacy and safety assessments, and risk mitigation strategies in Phase III clinical trials," PhRMA noted...Imposition of a de-facto comparative effectiveness standard would make many worthy drug development programs infeasible," the organization said.By Mari Serebrov | BioWorld Today | Friday, May 10, 2013
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