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Galapagos Lands $71M from Stoked U.S. Investors
The first clinical trials of the drug, GLPG1790, are expected to start within the next year.By Nuala Moran | BioWorld International | Wednesday, May 8, 2013 -
GSK Launches Clinical Data Portal in Transparency Move
GSK is a research partner of CluePoints Inc., a Cambridge, Mass.-based company Busye founded to develop an automated system for statistical monitoring of clinical trial dataBy Cormac Sheridan | BioWorld International | Wednesday, May 8, 2013 -
Pharma: Clinic Roundup
The study, dubbed Gammaglobulin Alzheimer's Partnership, was conducted in collaboration with the Alzheimer's Disease Cooperative Study, a clinical trial consortium supported by the National Institute on AgingBioWorld Today | Wednesday, May 8, 2013 -
Tufts Study: More Cancer Drugs Succeeding in the Clinic
Success rates doubled for cancer drugs that entered clinical trials in the early 1990s and those that entered the clinic a decade later, even as the number of such compounds increased by 50 percent over the period, according to a new analysis by the Tufts Center for the Study of Drug Development (CSDD...However, small molecules dominated as a percentage of cancer drugs entering clinical trials, representing 73 percent of compounds during 1993 to 1998 and 71 percent in 1999 to 2004By Marie Powers | BioWorld Today | Wednesday, May 8, 2013 -
N30 Seeks Road to Cystic Fibrosis Therapy, Without VCs
Vertex has done a wonderful job of pointing the way in terms of clinical trial design and endpoints," he saidBy Marie Powers | BioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion...The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining ofBioWorld Today | Tuesday, May 7, 2013 -
Arrowhead Bolsters Balance Sheet, Adds $36M for Pipeline
shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infectionBy Jennifer Boggs | BioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
clinical trials where a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugsBioWorld Today | Monday, May 6, 2013 -
Bench Press: BioWorld Looks at Translational Medicine
classification, which may have a direct effect on treatment recommendations for patients, and provides opportunities for genome-guided clinical trials and drug developmentBioWorld Today | Monday, May 6, 2013 -
Galapagos Lands $71M from Stoked U.S. Investors
The first clinical trials of the drug, GLPG1790, are expected to start within the next yearBy Nuala Moran | BioWorld Today | Monday, May 6, 2013 -
Other News To Note
filings, Merck's Canadian subsidiary transferred sponsorship of all vernakalant clinical trial applications to Cardiome...It outlines current scientific knowledge about the mechanistic basis of adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis and the optimization of clinical trial designs, including the selection of appropriate clinical trial endpoints, selection of patients who are likely responders to therapeutic stimulation of collateralBioWorld Today | Friday, May 3, 2013 -
Clinic Roundup
Ltd., of Germantown, Md., said it filed an investigational new drug application (IND) to begin clinical trials of its adipose-derived stem cell product, RNL-JointStem, for the treatment of osteoarthritisBioWorld Today | Friday, May 3, 2013 -
Other News To Note
Bionomics Ltd., of Adelaide, South Australia, initiated manufacturing activities at Lonza Group Ltd.'s facility in Slough, UK, to enter BNC101 into clinical trials following completion of key preclinical studies...Bionomics hopes to begin clinical trials in 2014BioWorld International | Wednesday, May 1, 2013 -
FDA Gives its Nod to Procysbi; Raptor Ascends
FDA approval was based on a new drug application comprising data from six clinical trials, including a randomized, multicenter, active-controlled Phase III trial of 43 patients with NC and extension data from that trialBy Marie Powers | BioWorld Today | Wednesday, May 1, 2013 -
Epizyme Files for IPO, Aims for $69M for Epigenetics Platform
The funding allowed ReXceptor to enter a formal partnership with C2N Diagnostics, which will assist the company with the initiation and coordination of the clinical trial of an AD program licensed from Case Western's Technology Transfer Office and based on discoveries that bexarotene, a medication sold at Targretin for cutaneous T-cell lymphomas, reversed AD symptoms in mice within 72 hours of a single dose of treatment.By Jennifer Boggs | BioWorld Today | Monday, April 29, 2013 -
Avaxia's Barbara Fox Stays on the Run at BIO 2013
Yes," Fox said, but the diseases are different enough in nature, including tissue penetration, that UC looked superior from a patient management perspective in the clinical trialsBy Marie Powers | BioWorld Today | Monday, April 29, 2013 -
Regulatory Harmonization on the Horizon for Taiwan, China
It's an attractive prospect for global pharmaceutical companies as it presents the best of both worlds: access to the huge market of China, while taking advantage of Taiwan's clinical trial infrastructure...GSK Taiwan general manager Thomas Willemsen explained the attraction of Taiwan as a clinical trial locationBy Dave Silver | BioWorld Today | Monday, April 29, 2013 -
Biotechnology Company Deals With Other Biotechnology Companies: Feb. 1 - April 25, 2013
Alnylam will develop the program through preclinical and early clinical trials, and Medicines will take over from Phase II onward, as well as commercialization 2/5/13 Viropro Inc. (Washington) Oncobiologics Inc. (Cranbury, N.J.) ND Biosimilar collaboration agreement giving Viropro the rights to manufacture six generic versions of Humira, Rituxan, Avastin, Herceptin, Erbitux and one other non-disclosed product Viropro will have exclusive commercialization rights to the six biosimilars forBioWorld Insight | Monday, April 29, 2013 -
Orphan Drugs Market Becoming Major Business for Industry
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), last year biopharmaceutical research companies had approximately 460 medicines targeting rare diseases either in clinical trials or awaiting FDA review. (See BioWorld Insight, Oct. 15, 2012.) That total now has grown to well over 500 medicines...Since the beginning of the year the FDA Office of Orphan Drug Products has granted 69 compounds orphan drug designation (ODD), with drugs intended to treat rare diseases orBy Peter Winter | BioWorld Insight | Monday, April 29, 2013 -
Alzheimer's Continues to Get Short End of the Budget Stick
The NIH has helped fund two clinical trials – one that's testing an insulin nasal spray to treat patients with Alzheimer's and a prevention trial in people at the highest risk of the disease. (See BioWorld Today, May 16, 2012.) Other projects include whole genome sequencing to identify new genetic variants that increase or reduce the risk of the disease, new stem cell methods, tools to improve care and steps to address inappropriate use of drugs to treat behavioral symptoms, Donald MouldsBy Mari Serebrov | BioWorld Today | Friday, April 26, 2013
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