Search Results for: Pharma: Clinical Roundup
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Clinic Roundup
Acacia Pharma Ltd., of Cambridge, UK, said it started a Phase II study of APD421, a drug that comprises an intravenous formulation of a marketed dopamine D2 antagonist, in the prevention of postoperative nausea and vomiting...Bionor Pharma ASA, of Oslo, Norway, and partners Eurocine Vaccines AB, of Solna, Sweden, and Oslo University Hospital reported that the nasal immunization study combining Bionor's Vacc-4x and Eurocine's adjuvant Endocine is fully enrolled...Additional data showed 69 percent of -
Clinic Roundup
Acacia Pharma Ltd., of Cambridge, Mass., reported Phase IIa data for APD209 in cancer cachexia, given to 13 patients with an average weight loss of 11.4 percent in the previous six months...Aesrx LLC, of Newton, Mass., said it started a clinical trial to test Aes-103, its anti-sickling agent, in healthy volunteers...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported top-line results from the Phase III GetGoal Duo 1 study, which showed that once-daily GLP-1 inhibitor -
Clinic Roundup
Gilead submitted the new drug application for the single-tablet Quad pill in October. (See BioWorld Today, Sept. 21, 2011...Vivus submitted a new drug application in July for avanafil, a selective phosphodiesterase Type 5 inhibitor, for erectile dysfunction...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, presented new results from a four-week Phase II study showing that GLP-1 agonist Lyxumia (lixisenatide) produced significantly greater postprandial glucose lowering -
Mpex Successor Rempex Snags up to $67.5M in Series B
In April, Aptalis Pharma Inc. (formerly Axcan Holdings Inc.), based in Mont-Saint-Hilaire, Quebec, agreed to acquire the outstanding shares of Mpex and lead candidate, Aeroquin, an aerosol formulation of levofloxacin in Phase III trials for the treatment of pulmonary infections in patients with cystic fibrosis...We've got a fully formed clinical group here, so we'll be doing the clinical work in house," Burgess said -
Clinic Roundup
Clinical follow-up, completed three months after the administration of PLX-PAD cells, noted statistically significant improvements in several parameters, including ankle-brachial index (p = 0.033), transcutaneous oxygen pressure (p = 0.05), quality of life (p < 0.001) and visual analogue score (p = 0.013...Vertex filed a new drug application last month seeking approval of Kalydeco in CF patients who have at least one copy of the G551D mutation in the CFTR gene. (See BioWorld Today, June 10, 2011 -
Verastem Files Surprise $50M IPO for Cancer Stem Cell Work
NanoViricides said it is moving toward an investigational new drug application filing for influenza candidate NV-INF-1. -
Topica Raises $27M Series B For Nail Antifungal Trial
Complete cure is the primary clinical endpoint for the conduct of pivotal clinical trials seeking FDA approval, Topica said...Net proceeds will be used for clinical trials activities related to completion of enrollment and ongoing patient dosing for the trial testing davunetide in progressive supranuclear palsy, as well as for general corporate purposes and working capital -
Clinic Roundup
Action Pharma A/S, of Aarhus, Denmark, released top-line results for its Phase IIb AP214 trial in patients undergoing major cardiac surgery, indicating that AP214 is safe, reduces kidney injury and improves 90-day outcomes on a composite end point (death, dialysis and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury...The company filed a clinical trial application with the Medicines and Healthcare -
Clinic Roundup
Niiki Pharma Inc., of Hoboken, N.J., reported interim data from a Phase I study of NKP-1339 in patients with metastatic solid tumors resistant to standard therapies showing that six of the first 24 patients enrolled (25 percent) exhibited antitumor activity demonstrated by disease stability and/or tumor regression for at least 12 weeks...With those safety data, plus results from two Phase III studies, Santarus is planning a new drug application submission for budesonide for the induction of -
Clinic Roundup
Bionor Pharma ASA, of Oslo, Norway, reported results from a multinational Phase IIb, placebo-controlled multicenter study of Vacc-4x, a therapeutic HIV vaccine based on four synthetic slightly modified peptide sequences from conserved parts of the P24 capsid protein of the HIV virus...In July, the FDA approved the company's investigational new drug application for QLT091001, whose clinical trial application also has been cleared by the U.K. Medicines and Healthcare Products Regulatory Agency -
Clinic Roundup
The study, initiated in April, enrolled 52 patients at clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon to evaluate the safety and tolerability of HQK-1001...pSivida Corp., of Watertown, Mass., said it opened an investigational new drug application for a Phase I/II trial of its injectable, sustained-release insert designed to deliver the corticosteroid fluocinolone acetonide) in uveitis affecting the posterior segment of the eye...Tranzyme Pharma Inc., of Research Triangle Park, N.C -
Tensha Bags $15M Financing For Bromodomain Inhibitors
To further pursue bromodomains, Bradner sought partners in the pharma, nonprofit and financing worlds...The financing will allow Tensha to advance its lead program through clinical proof of concept, lay the groundwork for clinical studies in other cancer indications and advance the preclinical development of bromodomain inhibitors in areas outside of oncology, according to Onsi, who declined to speculate on a timetable for any investigational new drug filings -
Aura's Nano-Based Delivery Attracts Funding, NCI Deal
After reaching clinical proof of concept, it can seek the bigger markets...The specialty pharma and diagnostics company entered the deal with the Swiss firm in May. (See BioWorld Today, May 26, 2011.) -
Clinic Roundup
DelMar Pharma Ltd., of Vancouver, British Columbia, said the FDA cleared its investigational new drug application to start clinical testing of VAL-083, a bifunctional alkylating agent, in refractory glioblastoma multiforme (GBM -
Clinic Roundup
Clavis Pharma ASA, of Oslo, Norway, said that interim efficacy data from a Phase II trial showed promising clinical activity from a combination treatment of elacytarabine and idarubicin in patients with acute myeloid lymphoma who have failed cytarabine-containing, first-course chemotherapy...Verona Pharma plc, of London, said that its bronchodilator RPL554 showed sustained action in a Phase II trial in patients with asthma -
Tarsa Pads Coffers Ahead of NDA Filing for Oral Calcitonin
The Swiss pharma firm's candidate uses a drug delivery technology from Cedar Knolls, N.J.-based Emisphere Technologies Inc...cardiac clinical trial, a European indication-for-use for the Celution system in treating nonoption chromic myocardial ischemia patients, Celution regulatory approvals in additional countries and a strategic partnership...Shares of Cytori (NASDAQ:CYTX) gained 1 cent Tuesday to close at $5.22. -
Lotus Gets $26M Series A: Skin Disease, Wound Healing
A.P. Pharma Inc., of Redwood City, Calif., entered a definitive agreement with new and existing investors to raise $24 million in a private placement of common stock and warrants...The company said it plans to use the funds to resubmit its new drug application for its APF530 for the prevention of chemotherapy-associated nausea -
Clinic Roundup
LifeCycle Pharma A/S, of Horsholm, Denmark, said lead candidate LCP-Tacro demonstrated noninferiority compared to Prograf (tacrolimus, Astellas Pharma Inc.) in a Phase III trial enrolling 326 stable kidney transplant recipients...Senesco Technologies Inc., of Bridgewater, N.J., said the FDA removed the clinical hold on the company's investigational new drug application for SNS01-T in multiple myeloma -
Tesaro Scores Biggest 2011 VC Round with $101M Series B
Inc. (See BioWorld Today, Dec. 16, 2010.) Hedley said the company anticipates starting its first ALK inhibitor clinical trial in mid-2012...OncoSec said it intends to use proceeds from the offering for further development of its ElectroOncology therapies to treat cancers, for clinical studies and for general corporate purposes. -
Ultragenyx's Rare Disease Focus Attracts $45M in Series A Round
Assistant Managing Editor Proving that big pharma firms aren't the only ones interested in the orphan disease space, venture investors are getting behind 2010 start-up Ultragenyx Pharmaceutical Inc...Funds will be used to prepare and submit a new drug application for lead product lomitapide in homozygous familial hypercholesterolemia (HoFh), complete clinical and nonclinical studies in HoFH, advance development of the drug in pediatric and adolescent patients and for general corporate purposes