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Other News To Note
The new partners plan to start clinical trials following an investigational new drug application later this yearBioWorld Today | Thursday, March 28, 2013 -
Broad, But Not Too Broad, Block of FGF Receptors Foils Tumors
In their experiments, the team used the ligand trap FP-1039, which is now in clinical trials for the treatment of solid tumorsBy Anette Breindl | BioWorld Today | Thursday, March 28, 2013 -
Aastrom Terminates CLI Trial; Restructures, Shifts to DCM
As well, Colangelo said, "enrollment criteria were a little strict," and it was a slow process getting clinical trial centers, many of them at academic institutions, up and runningBy Catherine Shaffer | BioWorld Today | Thursday, March 28, 2013 -
SEEK's $38M to Back Spin-off; Keeps Vaccine, Antiviral Focus
Meanwhile, London-based SEEK has finalized the clinical trial plans and signed up the contract research organization to conduct Phase III studies of the two lead products in the in-house portfolio, which are vaccines against influenza and HIV...Still, Stoloff is hopeful of finding a nongovernmental organization to back clinical trialsBioWorld International | Wednesday, March 27, 2013 -
Other News To Note
3SBio Inc., of Shenyang, China, called an extraordinary general meeting of shareholders for April 25 to vote on the merger plan with Decade Sunshine Ltd. and its wholly owned subsidiary Decade Sunshine Merger Sub. The merger would result in 3SBio becoming a privately held subsidiary of Decade Sunshine Ltd., with its American Depository Shares no longer listed on the Nasdaq Global Market. The company's board of directors approved the merger agreement and recommended that shareholders vote toBioWorld International | Wednesday, March 27, 2013 -
Vivus Plays for Time; Enters $110M Capped Royalty Deal
Net proceeds totaled $12 million and will be used to fund R&D and clinical trials, acquisition of intellectual property and other purposesBy Catherine Shaffer | BioWorld Today | Wednesday, March 27, 2013 -
FDA Proposes Framework for Patient Enrichment Strategies
With the cost of clinical trials climbing, the FDA is worried about its ability to obtain sufficient information to make determinations about safety and efficacy claims when examining new drug applications and biologics license applications...In December, the agency issued a draft guidance on potential enrichment strategies for clinical trials, examining ideas such as adaptive designs, reduced data collection, more targeted monitoring and the use of data available in health care delivery settingsBy Marie Powers | BioWorld Today | Wednesday, March 27, 2013 -
Other News To Note
The data supported previous findings in rodent models and may predict a therapeutic dose range to be identified in upcoming clinical trials, expected to start midyearBioWorld Today | Wednesday, March 27, 2013 -
Collaborations Between Biotechnology Companies And Government/Nonprofit Institutions: Dec. 1, 2012 - March 21, 2013
clinical trial of defibrotide, a drug in development for veno-occlusive disease, in healthy adults LINK will be responsible for administrative and logistical support for the trial, and HUSM will carry out the trial 12/6/12 iBio Inc. (Newark, Del.) National Institute of Allergy and Infectious Diseases Contract Granted to the company's research and development collaborator, the Fraunhofer USA Center for Molecular Biotechnology, for a new generation anthrax vaccine to be developed with theBioWorld Insight | Monday, March 25, 2013 -
Clinic Roundup
Cellular Biomedicine Group, of Palo Alto, Calif., launched a clinical trial for TC-DC (Tumor Stem Cell-Specific Dendritic Cell) therapy for hepatocellular carcinoma...It is the first immune cell clinical trial of its kind in ChinaBioWorld Today | Friday, March 22, 2013 -
Enanta Raises $56M in IPO; Soars on First Day Trading
Net proceeds are expected to support clinical trial costs and acquisition of manufacturing equipment, leasehold improvements and general corporate purposesBy Jennifer Boggs | BioWorld Today | Friday, March 22, 2013 -
PDAC Weighs Risks, Benefits of Implantable Buprenorphine
The doses for clinical trials appeared to be too low," she said, "And only one minimum effective dose was identified...As noted in clinical trials to date, only a single site on each arm has ever been evaluatedBy Catherine Shaffer | BioWorld Today | Friday, March 22, 2013 -
New Antimalarial Compound Raises Hopes of Eradication
It has not yet been tested in humans, and its solubility will need to be improved before it is ready for human clinical trials, so how long it will last in the human bloodstream is unclearBy Anette Breindl | BioWorld Today | Thursday, March 21, 2013 -
Antibiotic Developer Tetraphase Prices Initial Public Offering
The German Federal State of Saxony and the European Union funded the grant, which supplements a grant awarded by the SAB in August 2011 for the CANVAS clinical trial...Net proceeds of about $12 million will be used to support R&D, acquisition of intellectual property related to complementary drug therapies, clinical trials and other expensesBy Peter Winter | BioWorld Today | Thursday, March 21, 2013 -
Other News To Note
TTP488 is the first drug related to Receptor for Advanced Glycation Endproducts, a relatively new biological target in AD research, and has demonstrated success in multiple clinical trialsBioWorld Today | Wednesday, March 20, 2013 -
2,242 Trial Deaths, Few Rules: India Aims for Regulatory Reform
India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong...policy, guidelines and standard operating procedures" for clinical trials and how they relate to approvals, as well as for banning drugs and regulating fixed-dose combinationsBy Randy Osborne | BioWorld International | Wednesday, March 20, 2013 -
Committee to Scrutinize Titan's Implantable Buprenorphine
Commenting on Titan's clinical trial results, the agency raised questions about the adequacy of Probuphine's effectBy Catherine Shaffer | BioWorld Today | Wednesday, March 20, 2013 -
Helmedix Lands Seed Funding to Back Helminth Peptide R&D
Numerous animal studies bear this out, and there have been a few approved clinical trials of live worms or worm eggs as probiotic treatments for ulcerative colitis and multiple sclerosisBy Nuala Moran | BioWorld International | Wednesday, March 20, 2013 -
Other News To Note
The case of PML is the only known incidence in approximately 9,800 MF patients treated with ruxolitinib worldwide in clinical trials or commercial product, according to IncyteBioWorld Today | Tuesday, March 19, 2013 -
Trials: Nobody's Perfect, Randomized Controlled or Not
They give us the most robust evidence," Caroline Sabin of University College London told the audience at a recent workshop on clinical trial design...in cancer clinical trials, for example, patients with metastatic disease are often excludedBy Anette Breindl | BioWorld Today | Monday, March 18, 2013
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