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.)

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

The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS...Additional edata will be presented at the annual meeting of the American Society of Clinical Oncology in Chicago...ACT is currently enrolling patients in three clinical trials in the U.S

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

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

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

Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer

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.

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

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 months

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.

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.

Using ViS' online analytics platform, the initiative is expected to reduce the barriers to global pediatric clinical research by helping drugmakers identify patients, enabling streamlined trial enrollment and site selection...Eventually, it could be used to find research centers, staffing talent and other resources needed to conduct a pediatric clinical trial in a specific region...To get FDA authorization to charge for an investigative drug or for an unapproved use of an approved drug in a clinical