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| Today's Top Story |  |  | | - Janssen and GSK launch late-stage trials of RA drug sirukumab
Janssen Biologics and GlaxoSmithKline initiated two Phase III trials to evaluate the efficacy of human anti-interleukin-6 monoclonal antibody sirukumab, or CNTO 136, in patients with moderately to severely active rheumatoid arthritis. The SIRROUND-T study involves patients with active RA despite treatment with anti-tumor necrosis factor drugs. The SIRROUND-D trial focuses on patients with active RA despite anti-rheumatic treatment. Reuters (8/23)        | Earn 2X rewards points on shipping costs with The Business Gold Rewards Card from American Express OPEN. Designed to earn Membership Rewards® points faster:
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  | Health Care & Policy | | | | - EnVivo prepares for pivotal trial of Alzheimer's drug
EnVivo Pharmaceuticals plans to initiate next year a pivotal study of Alzheimer's disease drug EVP-6124, after obtaining promising results from a midstage trial. The firm is discussing the study's design with U.S. and European regulators. EVP-6124, which belongs to a class of drugs called alpha-7 nicotinic agonists, is designed to improve transmission between brain synapses. Xconomy/Boston (8/23) - Pluristem will test cell therapy for peripheral artery disease
Pluristem Therapeutics, which makes placenta-based cell treatments, will begin next month a midstage trial to assess the safety and efficacy of its PLacental Expanded cells as a therapy for intermittent claudication, a type of peripheral artery disease. The trial will be conducted at 11 sites across U.S. Globes (Israel) (8/23) - FDA unveils draft guidance for Generic Drug User Fee Amendments
The FDA issued a draft guideline for Generic Drug User Fee Amendments to the Prescription Drug User Fee Act. The agency's website features documents including guidance for generics-makers on self-identification of generic-drug sites, organizations and facilities, as well as questions and answers about the guideline. FDA officials and drugmakers are hoping that the amendments will guarantee faster review of generic-drug applications and reduce backlog. Drug Store News (8/23) - Scientist plays matchmaker to grow tissues
Yoshiki Sasai, a stem cell biologist at the Riken Center for Developmental Biology in Kobe, Japan, coaxes embryonic stem cells to grow into tissues not by perturbing them but by giving them the right conditions and permitting them to grow undisturbed. Sasai's method allows embryonic stem cells to float in an aggregate devoid of signaling molecules and other external cues. He has grown brain and retinal tissue and a pituitary gland. Nature (8/22/2012) | Company & Financial News | | | | - Stem cell firm pulls in $9.2M in financing
Fate Therapeutics said in a regulatory filing that it secured $9.2 million in equity financing. The U.S. firm develops treatments based on stem cell modulators that guide the maturation of the cells. ProHema, Fate's most advanced therapy, guides blood-forming stem cells and is under clinical development for use with stem cell transplants in patients with blood cancer. North County Times (Temecula, Calif.) (8/23)
| Food & Agriculture | | | | - Chinese study tests spread of biotech genes
Chinese researchers looked at the progeny survival rates of wild type rice plants crossed with biotech, insect-resistant varieties in a field study. Transferred genes didn't improve the survival of the wild plants when plant pest rates were low, researchers said. SciDev.net (8/22) | Industrial & Environmental | | | | | News from BIO | | | | - Are you taking full advantage of your membership?
BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here.
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