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 candidate
By Marie Powers | BioWorld Today | Friday, May 24, 2013
Results of the PROLASTIN-C SPARK study, a multidose pharmacokinetic clinical trial, were presented at the annual meeting of the American Thoracic Society in Philadelphia
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 Philadelphia
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
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
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 for
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 Cleveland
The money should carry the new company "for about three years-plus," Worlund said, long enough to get clinical proof of concept with a lead program...Karyopharm is expected to present data from its Phase I study testing lead SINE program KPT-330 in solid tumors at the upcoming American Society of Clinical Oncology meeting in Chicago...Founded in 2009, Karyopharm previously raised about $32 million, including a $20 million Series A round in late 2010 and a $10 million Series A2 round in 2011. (See
By Jennifer Boggs | BioWorld Today | Tuesday, May 21, 2013
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
Data from a single-arm, 333-patient Phase II trial reported at the American Society of Hematology meeting in December demonstrated quizartinib's high response rate in relapsed/refractory FLT3-ITD-positive patients, with results besting clinical outcomes reported for other kinase inhibitors...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories
By Jennifer Boggs | BioWorld Today | Friday, May 17, 2013
Sangamo BioSciences Inc., of Richmond, Calif., said it presented new clinical data, which demonstrated that SB-728-T treatment resulted in a reduction in the HIV reservoir in HIV-infected subjects, at the 16th Annual Meeting of the American Society of Gene and Cell Therapy in Salt Lake City...HIV-infected subjects enrolled in an ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T, which resulted in a durable increase in total CD4 T-cells driven by increased ZFN
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 sclerosis
By Jennifer Boggs | BioWorld Today | Thursday, May 16, 2013
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-free
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 molecules
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 programs
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
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 programs
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 experience
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
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
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 candidate