HeartWare Receives Conditional Approval of IDE
FRAMINGHAM, Mass. and SYDNEY, Australia, May 5 /PRNewswire/ -- HeartWare Limited (ASX: HTW) today announced that it had received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the HeartWare(R) Le...USDA Agrees to Grant Conditional License to Bioniche for its E. coli O157:H7 Cattle Vaccine
BELLEVILLE, ON, Feb. 5 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today received notice from the United States Department of Agriculture (USDA) that the latest data for its E. coli O157:H7 cattle vacc...Prozac Gets Conditional Clearance For Treating Children
Prozac has been cleared for treating children over eight years suffering from depression, but regulators have imposed strict conditions on its use//. The conditions imposed by the European licensing agency (EMEA) call for the use of the drug only when other therapies have failed. "Prozac shou...CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology
... for the development of products containing a protein hydrogel, which is the primary component of BioFoam." In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase w...SOWSIA's Inpatient EHR Solution Gets '08 CCHIT Certification
... SAN FRANCISCO, July 22 /PRNewswire/ -- SOWSIA Healthcare Solutions Inc.'s product Ondemand Healthcare uHPM, 7Plus, M1 is now a pre-market conditional CCHIT Certified(R) 08 Inpatient EHR. The Certification Commission for Health Information Technology (CCHIT(R)) made this announcement today. ...Prevent Disaster with New Low Cost Temperature Scan Wireless Monitoring System
...tup different reading configurations for each sensor, allowing the ultimate flexibility and customization. Customized alerting capabilities allow for conditional alerts to be sent via email, pager and a number of other possibilities. There are no hidden or monthly recurring fees and the system is modular al...Econiche(TM) Vaccine Efficacy Summarized in July Issue of Foodborne Pathogens and Disease
...for unrestricted use by Canadian cattle producers and their veterinarians. The United States Department of Agriculture (USDA) cleared the path for a conditional license for the vaccine in February, 2008, and the Company is in the process of completing the required manufacturing steps in the U.S. at this time. ...DuraHeart(TM) LVAS Receives Conditional Approval for US Pivotal Trial
ANN ARBOR, Mich., March 3 /PRNewswire/ -- Terumo Heart, Inc. announced today that they have received conditional approval from the Food and Drug Administration (FDA) to begin enrollment in the US Pivotal Trial of the DuraHeart (TM) LVAS for a Bridge-to-Transplant (BTT) indication. (Logo: ht...Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)
Primary Endpoint of the Trial to Be Clarified with FDA WALTHAM, Mass., Feb. 22 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. (OTC Bulletin Board: ABOS) announced today that the Company has received conditional approval from the U.S. Food and Drug Administration ("FDA") of an Investig...Sunshine Heart Announces IDE Approval To Begin C-Pulse U.S. Clinical Feasibility Trial
...e/ -- Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, today announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its first U.S. clinical feasibility tr...PLC Systems Announces Approval of First European Study to Evaluate RenalGuard(TM)
...positive safety data collected in the pilot study and discussions with FDA, PLC stopped enrolling new patients in the pilot study and has received FDA conditional approval to commence a U.S. pivotal trial to study the effectiveness of its RenalGuard in the prevention of CIN. Contrast-Induced Nephropathy Appr...FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
...D, Fla., May 13 /PRNewswire/ -- USHIFU, LLC, the clinical trial management provider for Focus Surgery, Inc. (Indianapolis, IN), is pleased to announce conditional written approval pending minor changes to the protocol from the FDA to begin a pivotal trial for the treatment of recurrent prostate cancer with the S...Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device
...pleased to have received FDA approval to start the SEPET pivotal trial and to have fully satisfied the points addressed in the FDA's previously issued conditional approval," commented CEO and President Shawn Cain. "We were pleased with the compelling results from the SEPET feasibility trial, and we are excited t...Telomeres resemble DNA fragile sites
...he discovery is a protein known as TRF1, which de Lange, in an effort to understand how telomeres protect chromosome ends, discovered in 1995. Using a conditional mouse knockout, de Lange and Sfeir have now revealed that TRF1, which is part of a six-protein complex called shelterin, enables DNA replication to dr...K-State researchers help Epitopix license the United States' first E. coli O157 vaccine for cattle
...exas A&M University. "We're excited that this vaccine has been granted a conditional approval by the U.S. Department of Agriculture," Thomson said. "We have bee... a research collaborator for Epitopix to conduct the work that lead to this conditional approval. Epitopix will now be able to offer this pre-harvest food safety t...Forest inventories in California include more than trees
... average annually between 2001 and 2005. Modeling crown fire potential under extreme weather conditions showed that fire would occur as a surface or conditional surface fire in 72 percent of forests, and as a passive crown fire in only 20 percent of forests. In most cases, fuel treatment may require only th...October 2008 Biology of Reproduction highlights
...activity to determine the developmental role of DICER by whole-organism and conditional gene disruptions. In a paper on p. 696 of this issue, Maatouk et al. add im...1 is required for normal spermatogenesis in the mouse. These authors used a conditional knockout (CKO) approach to delete Dicer1 in the germline. Because the CKO...Sociological research shows combined impact of genetics, social factors on delinquency
...n behavioral motivation, aggression, emotion and cognition (e.g., serotonin, dopamine, norepinephrine). Among the findings, the research suggests a conditional interaction between repeating a school grade and the MAOA*2 repeat (2R) allele in adolescent boys. For those who did not have the 2R allele, repeating...It is important to demonstrate the influence of the microenvironment in the process of metastasis
... it was aimed at identifying the origin of the factors regulating the expression of those genes. An in vitro model based on crops in the presence of conditional media The in vitro model developed in this PhD thesis differs from current models in which the cell line from the human colon cancer is cultured i...Cell response to stress signals predicts tumors in women with common pre-breast cancer
...of breast cancer, which was a striking discovery, according to Tlsty. We found that the expression of biomarkers of a stress-associated response is conditional and can reflect two distinct processes distinguished by the absence or presence of a proliferation of cells, added Tlsty. We anticipate that these ph...'Smart' mice teach scientists about learning process, brain disorders
... being able to "knock out" the gene for Cdk5 only in the brain, and only when the mice were adults. This technique, only recently developed and called conditional knockout, allows much more sophisticated experiments than traditional knockout, which entirely eliminates the gene. "Being able to turn a gene of...Spelling out cancer on the nanoscale
... In previous work, the Felsher group had shown that inactivating MYC induces sustained tumor regression in mice. The researchers decided to test their conditional model of MYC-induced lymphoma by using their nano-fluidic system to quickly measure the impact of targeted protein inhibitors in mice. A series of fin...How the US drug safety system should be changed
...poses an alternative approach with three elements: conditional approval, an empowered US Food and Drug Administra...ally approved, it should ideally enter a period of conditional approval, he says. In this period, marketing, espe...d to be clearly marked that the drug's approval is conditional and has only been studied in a limited number of p...Schering-Plough Reports Financial Results for 2009 Second Quarter
...agent for use in heart bypass surgery; and In Animal Health, the launch of the first vaccine against canine influenza virus, which was granted a conditional product license by the U.S. Department of Agriculture (USDA) in May. Regarding the planned merger with Merck announced on March 9, ...Beckman Coulter, Inc. Announces Pricing of Common Stock Offering
...pect," "anticipate," "intend," "estimate," "may increase," "may fluctuate," "plan," "goal," "target," "strategy," and similar expressions or future or conditional verbs such as "may," "will," "should," "would," and "could." These statements are based on current expectations, forecasts and assumptions and are su...Beckman Coulter Prices $500 Million Senior Notes Offering
...pect," "anticipate," "intend," "estimate," "may increase," "may fluctuate," "plan," "goal," "target," "strategy," and similar expressions or future or conditional verbs such as "may," "will," "should," "would," and "could." These statements are based on current expectations, forecasts and assumptions and are su...GlaxoSmithKline and Stiefel to Create New World-Leading Specialist Dermatology Business
...s than 1%) and to be 1-2% accretive to EPS in 2010. The transaction has been approved by the Stiefel stockholders. Closing of the transaction is conditional upon certain matters including receiving certain regulatory clearances and no material adverse change occurring in respect of Stiefel's business prior...Pharmexa and Affitech to Combine Operations to Create a New Antibody Therapeutics Company
... COPENHAGEN and OSLO, March 4 /PRNewswire/ -- Pharmexa A/S and Affitech AS announced today that they have entered into a conditional agreement to merge the two companies by means of a share for share acquisition by Pharmexa A/S of the private Norwegian company, Affitech AS. The purp...Cytopia Letter to Progen Shareholders
...ing form is attached. The share buy-back resolution (Resolution 3) is conditional on the merger resolution (Resolution 1) being passed, and in any case, limi...es in 2009. Website: www.cytopia.com.au Notes Resolution 3 is conditional on Resolution 1 being passed, and in any case, limits the share buy-back to...Insmed Sells Follow-on Biologics Platform to Merck & Co., Inc. for Gross Proceeds of $130 Million
... approximately $1.2 million per month. This transaction, in accordance with Virginia corporate law, does not require a shareholder vote, though it is conditional on certain closing requirements, including obtaining necessary consents. RBC Capital Markets served as exclusive financial advisor to Insmed on...Cytopia and Other Progen Shareholders Maintain Call for Meeting
...have been put forward to Progen by shareholders, no merger resolution has been proposed, nor are the appointments of the three new director candidates conditional on a merger going forward. These directors seek appointment on a declared platform of considering a merger between Cytopia and Progen but such a merge...* Quick & Easy Conditional Knock Out Kit - FRT from Gene Bridges GmbH
Description: This kit is designed for the fast and simple integration of FRT-sites into large vector plasmids at any position (for the generation of transgenic mouse models). The included FRT-PGK-gb2-neo-FRT cassette is designed to allow neomycin / kanamycin selection in prokaryotic and eukaryotic cells. It com...* Quick & Easy Conditional Knock Out Kit - loxP from Gene Bridges GmbH
Description: This kit is designed for the fast and simple integration of loxP-sites into large vector plasmids at any position (for the generation of transgenic mouse models). The included loxP-PGK-gb2-neo-loxP cassette is designed to allow neomycin / kanamycin selection in prokaryotic and eukaryotic cells. It ...