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Regulators in Medical News

Industry Experts and Global Regulators to Discuss Oligonucleotide-Based Therapeutics Issues

The Drug Information Association (DIA), in collaboration with the FDA, Oligonucleotide Therapeutics Society, Health Canada, and the American Association of Pharmaceutical Scientists, will host the 2nd Conference on Oligonucleotide-based Therapeutics (September 22 - 24; Falls Church, VA). ...

Blue Shield Settlement with Regulators Timed to Fend Off L.A. City Attorney's Lawsuit

SANTA MONICA, Calif., July 17 /PRNewswire-USNewswire/ -- Governor Schwarzenegger and regulators announced a company-friendly settlement with Blue Shield today on the heels of a new lawsuit filed by the Los Angeles City Attorney that could cost the company $1 billion for retroactively canceling...

Neuronal regulators offer potential targets for cancer

Boston, Mass. (March 19, 2008) -- Being too brainy can be a bad thing in a junior high cafeteria, where the social hierarchy favors other traits. "Braininess" also causes problems for cells. When a breast cell begins making the proteins normally produced in neurons, for example, it can acquire can...

Deficient regulators in the immune system responsible for type 1 diabetes

Montreal, 24th January 2008 - The main regulators of the immune system, called CD4+Treg cells, are thought to be highly involved in a large range of immune diseases. The gradual reduction in their regulating capacity seems to play a critical role in the onset of type 1 diabetes, as demonstrated in...

AARP Calls on State Regulators to Reject Proposed Settlement of TXU Buyout

'Who's looking out for everyday Texans?' AUSTIN, Texas, Oct. 5 /PRNewswire-USNewswire/ -- AARP today said a proposed settlement of the record-setting $45 billion buyout of TXU amounts to one more backroom deal that ignores the interests of residential customers and in essence e...

Squeamish Colorado Dental Patients Get Drilled By Self-Interested Regulators

Colorado dental patients are being harmed by the very State regulators who are appointed by Governor Bill Ritter to protect them, a newly formed group, Holorado, contends. Self-interested Colorado regulators have "mile-highjacked the process" to place their own financial interests ahea...

International Food Protection Training Institute to Deliver Inaugural Training Course to Food Safety Regulators

'Managing Retail Food Safety,' SET FOR July 14-16 BATTLE CREEK, Mich., May 21 /PRNewswire/ -- The International Food Protection Training Institute (IFPTI) announced today that it will deliver its inaugural training course -- the FDA's "Managing Retail Food Safety" -- on July 14-16, 2009 at ...

Promising new TB drug given special status by US and European regulators

What: Approximately one-third of the worlds population is infected with Mycobacterium tuberculosis, the bacterium that causes TB, and an estimated 1.6 million people died of the disease in 2005. Currently, TB patients must adhere to a complex treatment regimen over a six- to nine-month period. Thi...

Researchers Urge Regulators to Rethink Strategies for Soot Emission

Carnegie Mellon University researchers say government officials need to adopt new ways of measuring and regulating the fine particles of smoke and soot so endemic// to serious health problems and the global warming crisis. In a March 2 article published in the journal Science, professors All...

New Study Challenges How Regulators Determine Risk

A new study provides the strongest evidence yet that a key portion of the traditional dose-response model used in drug testing and risk assessment// for toxins is wrong when it comes to measuring the effects of very low doses. Edward J. Calabrese, a scientist at the University of Massachusetts...

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Regulators in Medical Technology

Latest Cell Publication Describes the Novel Kinase Regulators Using OriGene's Functional Kinome Collection

ROCKVILLE, Md., May 5th /PRNewswire/ -- Scientists from University of Helsinki, Institute of Molecular Medicine in Finland and OriGene Technologies joined effort in creating the most comprehensive kinome collection of nearly all predicted human protein kinases, including the functional kinases...

Prospective Clinical Advantages of Trabecular Metal(TM) Technology Highlighted in Comparative Study

...and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration and foreign government regulators and tax obligations and risks; the impact of temporarily suspending U.S. distribution of one of our key hip replacement products; product liability an...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

...tient global impression of change. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use. "F...ssion and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use. ...

Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Health (CDRH)

... Adaptive trials leader and CDRH regulators join to create Bayesian trial design and analysis software standard CAMBRIDGE, Mass., June 22 /PRNewswire/ -- Cytel Inc., a leading provider of b...

Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

...and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use. Additional safety information for Xyrem, including black box warnings, can be foun...

Entremed Presents Results of ENMD-2076 Phase 1 Study in Advanced Cancer Patients

...NMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers. ENMD-2076 also targets the Flt-3 and FGFR3, kinases which have been shown t...

Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients

...e to collect safety data and to monitor patients after discontinuation of clevudine in the QUASH studies, but does not plan to submit study results to regulators as pivotal studies. Clevudine was licensed from Bukwang Pharmaceuticals of South Korea, where the drug is marketed under the trade name Levovir. ...

Prometheus and Rosetta Genomics Announce License and Collaboration Agreement

...particles and heavy metals. About MicroRNA MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of p...

Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A.

... the United States. Nor can there be any assurance that the planned dose escalation studies in Switzerland or any other country will not be delayed by regulators there or that those studies, when conducted, will be successful or provide data acceptable to the FDA. Additional information concerning these and ot...

Comparative Study Shows Significant Bone In-growth and Advanced Clinical Outcomes Using Zimmer's Trabecular Metal(TM) Technology

...and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration and foreign government regulators and tax obligations and risks; the impact of temporarily suspending U.S. distribution of one of our key hip replacement products; product liability an...
Regulators in Medical Products

Leptin IRMA Test

Description:...mones do not work in the short term, the long-term administration both in vivo and in vitro indicates that these two hormones may be some of the major regulators of leptin production by adipose tissue. Without an understanding of leptin regulation and how to circumvent leptin resistance, the use of leptin to t...
Company:Diagnostic Systems Laboratories, Inc.

Leptin ELISA Test

Description:...mones do not work in the short term, the long-term administration both in vivo and in vitro indicates that these two hormones may be some of the major regulators of leptin production by adipose tissue. Without an understanding of leptin regulation and how to circumvent leptin resistance, the use of leptin to t...
Company:Diagnostic Systems Laboratories, Inc.

Free Testosterone RIA Test

Description:...ns. Springer-Verlag, Berlin, 1986 Pugeat M, et al.: Androgens in polycystic ovarian syndrome. IN Tolis G, Bringer J, Chrousos GP (eds): Intraovarian regulators and polycystic ovarian syndrome. NY Academy of Sciences, New York, 1993, pp. 124-135....
Company:Diagnostic Systems Laboratories, Inc.

Free Testosterone EIA Test

Description:.... Springer-Verlag, Berlin, 1986 Pugeat M, et al.: Androgens in polycystic ovarian syndrome. IN Tolis G, Bringer J, Chrousos GP (eds): Intraovarian regulators and polycystic ovarian syndrome. NY Academy of Sciences, New York, 1993, pp. 124-135....
Company:Diagnostic Systems Laboratories, Inc.
Regulators in Medical Definition

Personalized medicine

...industry 2.2 Diagnostics industry 2.3 Customers 2.4 regulators 2.5 United States Policy 2.6 Genetics Discrimination ...Less than 5% of all private companies reimburse for genetic tests. regulators The Food and Drug Administration in the United States and their counte...
Regulators in Biological News

New molecular regulators of hyperthyroidism and goiter

The thyroid gland has an important role in determining how much energy the body burns. Thyroid gland functions are regulated by a hormone known as thyroid-stimulating hormone (TSH). Increased levels of TSH, as well as increased signaling through the receptor for TSH, result in hyperthyroidism (cha...

Small molecules mimic natural gene regulators

ANN ARBOR, Mich.---In the quest for new approaches to treating and preventing disease, one appealing route involves turning genes on or off at will, directly intervening in ailments such as cancer and diabetes, which result when genes fail to turn on and off as they should. Scientists at the Un...

Researchers use RNAi libraries to identify regulators of apoptosis and chemoresistance

When it comes to the deadly skin cancer melanoma, studying functional tissue rather than cell lines may better provide insight into the disease's development, according to new research from a Howard Hughes Medical Institute predoctoral fellow at Stanford University School of Medicine. Though mult...

Improved air quality during Beijing Olympics could inform pollution-curbing policies

...affic density and encouraging public transportation can have a significant impact on local air quality. "We hope our study can help or advise local regulators and policymakers to adopt long-term sustainable emission controls to improve air quality," Zhang said. "That's our mission." Published online July ...

Carnegie Mellon team makes sequestration recommendations

...ogical sequestration. Specific recommendations include: Amend the Safe Drinking Water Act to direct Underground Injection Control (UIC) program regulators to create adaptive, performance-based rules for geologic sequestration, and to include mechanisms to resolve conflicts between multiple environmental ...

Iowa State University researchers develop process for 'surgical' genetic changes

...rch from the lab to the field. Wright and Townsend hope the precision of this technique will speed the regulatory process. "In the random process, regulators would say, 'You really don't know what you're doing,'" said Townsend. "With this new technology, we can tell them, 'The genome looks like this, this i...

UH team analyzes Hurricane Ike's effects on waterways, fish contamination

...h project being conducted at the University of Houston may offer important information about the effects of Hurricane Ike on pollution levels and help regulators determine whether existing fish-consumption advisories remain appropriate. With this year's storm season under way, the UH engineering team's proje...

Canadian researchers set to study impact of nanomaterials on aquatic ecosystems

...n use the knowledge gained to properly engineer their products with reduced environmental impact." The research resulting from this study will help regulators understand the interaction of new molecules within our ecosystem, and inform and facilitate the development of sound regulatory policies in this area....

Stanford researchers publish comprehensive model for medical device development

...n healthcare innovation," says Pietzsch. "It is our aim to contribute to a greater understanding of such differences, particularly as policymakers and regulators work to design the least burdensome approaches to medical device regulation." The article emerged from research performed by the authors as part of...

Infant formula adulteration with melamine underscores need for better detection methods

...ivation for faking protein content can, unfortunately, be compelling. Rigorously defined quality standards and test methods can give manufacturers and regulators powerful tools to catch and discourage bad actorshelping to restore a shaken public confidence." Some have separated considerations of "quality" fr...
Regulators in Biological Technology

Oncothyreon appoints Diana Hausman as Vice President of Clinical Development

...on of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed with the securities regulators in the United States on U.S. EDGAR and in Canada on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) upda...

Oncothyreon announces presentation of long-term Stimuvax data at World Conference on Lung Cancer

...on of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed with the securities regulators in the United States on U.S. EDGAR and in Canada on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) upda...

Zimmer Launches New Medical Education and BioSkills Training Program

...and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration and foreign government regulators and tax obligations and risks; the impact of temporarily suspending U.S. distribution of one of our key hip replacement products; product liability an...

Wyeth Announces Stockholder Approval of Pfizer Merger at 2009 Annual Meeting

...bject to necessary global regulatory approvals and other customary closing conditions. On July 17, 2009, an important condition was met when European regulators announced that they had approved the merger. A closing date for the merger has not been announced, but the companies continue to expect the transacti...

Global Prescription Drugs Market to Cross $897 Billion by 2015, According to New Report by Global Industry Analysts, Inc.

...ts the second largest therapeutic class in 2009, followed closely by Lipid regulators market. However, owing to a spate of patent expiries, including that of Lipitor - the largest selling drug, lipid regulators are expected to witness a decline in revenues, and share of the global pres...

CEL-SCI Signs Definitive Agreement to Raise $5 Million in Registered Direct Offering

... the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); uncertainties regarding t...

Oncothyreon announces initiation of Phase 3 trial of Stimuvax in breast cancer

...on of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed with the securities regulators in the United States on U.S. EDGAR and in Canada on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) upda...

Greenway Medical Technologies To Display Live Interoperability Implementations at 2009 DIA Show

... Industry Leading Health IT Providers Collaborate to Demonstrate Interoperability with Clinical Sites, Research Sponsors and regulators through Utilization of RFD Standard CARROLLTON, Ga., June 19 /PRNewswire/ -- Greenway Medical Technologies, a leading provider of an integrated e...

Matthew Lehman of SPRI Clinical Trials Speaks On Designing Trials For Success At The Trout Group Investor Relations Seminar

...eet, held recently in Munich, Germany. He addressed CEOs and CFOs from private and small and mid-cap life science companies. The FDA and other regulators are the gatekeepers to realizing shareholder value and future profits, Lehman said. FDA goals of drug safety, efficacy and economic cost/benefit are ...

Oncothyreon appoints Scott Peterson as Vice President of Research and Development

...on of the risks and uncertainties associated with Oncothyreon, you are encouraged to review the official corporate documents filed with the securities regulators in the United States on U.S. EDGAR and in Canada on SEDAR. Oncothyreon is under no obligation to (and expressly disclaims any such obligation to) upda...
Regulators in Biological Products

Human BMP-5 ELISA development Kit, DuoSet Economy Pack from R&D Systems

Description:... are at least 20 structurally and functionally related BMPs, which are members of the TGF-beta superfamily. BMPs were originally identified as protein regulators of cartilage and bone formation. They are also involved in embryogenesis and morphogenesis of various tissues and organs. BMPs regulate the growth, di...
Company:R&D Systems

Porcine Leptin ELISA Kit from Diagnostic Systems Laboratories, Inc.

Description:...mones do not work in the short term, the long-term administration both in vivo and in vitro indicates that these two hormones may be some of the major regulators of leptin production by adipose tissue. Without an understanding of leptin regulation and how to circumvent leptin resistance, the use of leptin to t...
Company:Diagnostic Systems Laboratories, Inc.
Regulators in Biological Definition

Developmental biology

... embryonic development were identified. Transcription factors are the key regulators of which genes are expressed in cells. Transcriptional control in the var...enes for cell adhesion proteins. Cell adhesion proteins are among the key regulators of morphogenesis. Concepts in developmental biology allantois , a...

Homeostasis

...l to living things as the lack of it harms the genetic material. With regard to any parameter , an organism may be a conformer or a regulator . regulators try to maintain the parameter at a constant level, regardless of what is happening in its environment. Conformers allow the environment to determine ...

Hormone

... Greek diphthong in oestrogen and the unvoiced aspirant h in gonadotrophin. See also endocrine system plant hormones or plant growth regulators autocrine signalling paracrine signalling ...

Signal transduction

...on . Gene activation leads to further effects, since genes are expressed as proteins , many of which are enzymes, transcription factors or other regulators of metabolic activity. Because transcription factors can activate still more genes in turn, an initial stimulus can trigger via signal transduction th...
Regulators in Biological Dictionary

Plant hormones

...moved the Hormone Theory Section. 5 Phytochrome. 6 Move to Plant growth regulators ... Reid, D. M., and Wample, R. L. Water relations and plant hormones . ...dule of Master Gardener training program. ... Plant hormones and growth regulators are chemicals that affect flowering; aging; ... ...

Helix-turn-helix

...ary and Thesaurus. Cytokines & Cells Online Pathfinder Encyclopaedia ... The helix - turn - helix motif is detected in many transcription regulators (Brennan ... The helix – turn – helix motif of bacterial insertion sequence IS911 transposase is ... The second motif is a helix – tur...

Helix-loop-helix

...get='_blank'>Full article >>> (b) The structure of the helix - loop - helix motif. PDB ID = 1MDY. Review Article: Helix - Loop - Helix Proteins: regulators of Transcription in Eucaryotic Organisms ... BioInfoBank Library :: Helix - Loop - Helix Motifs :: The whcE gene of ... family of tissue-spec...

Group II introns

...-splicing ribozymes believed to be the ancestors of ... Many group II introns encode reverse transcriptases that promote both RNA ... Global regulators Orchestrate Group II Intron Retromobility ... Retrohoming: cDNA-Mediated Mobility of Group II Introns Requires a Catalytic RNA ... Gro...

Gene cluster

...me gene cluster . ... The a globin gene cluster contains different types of a hemoglobin, which help ... The current study did not yield new regulators for the human gene cluster . ... Complete information for IGH@ gene ( gene cluster ), immunoglobulin heavy locus ... ProtoNet protein ...

Biologics

... therapy, tissues, and recombinant therapeutic proteins created by biological processes . Vaccines, Blood & Biologics . 2009 CBER Foreign regulators Seminar ... Safety & Availability ( Biologics ) ... Science & Research ( Biologics ) ... Recalls, withdrawals, safety issues of fractionate...

Apoptosis

...tocols and Applications Guide is a resource for the most current information on Apoptosis . ... Detecting Apoptosis by Measuring ... ... central regulators of intrinsic apoptosis . pathways. 5. Regulatory mechanisms in apoptosis signalling. 5.1 The Bcl ... 1. The development of the term apoptosis ......
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(Date:4/14/2014)... treat children with uncomplicated acute appendicitis is a reasonable ... fewer missed school days, according to a pilot study. ... Hospital and published online April 12 in the ... the first prospective study on nonoperative management of acute ... , Researchers enrolled 77 patients age 7 to 17 ...
(Date:4/14/2014)... 2014, Perth, Australia. Drug discovery company Proteomics International ... of a companion diagnostic (CDx) test with the ... The research team authenticated the panel of biomarkers ... samples. Seven biomarkers were validated at high stringency ... The mass spectrometry data was then cross-validated using ...
(Date:4/14/2014)... 2014) When it comes to the cost and ... Patients get the best care when they are treated ... extensive experience in their current job, according to a ... and Columbia Business School. The study was published in ... Applied Economics . , The review of more ...
(Date:4/13/2014)... STANFORD, Calif. A low-cost empowerment program for ... and sexual harassment of these girls, who live ... and are frequently attacked, a large new study ... Stanford University School of Medicine, Lucile Packard Children,s ... No Worldwide, validated the program,s effectiveness in combating ...
(Date:4/11/2014)... the processes that control brain cell production could pave ... brain-related disorders. , Scientists have gained new understanding of ... how and when nerve and brain cells are formed ... and keeps it healthy. Their findings could help explain ... which is a fundamental characteristic of many diseases including ...
Breaking Medicine News(10 mins):Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 2Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 3Health News:Longer nurse tenure on hospital units leads to higher quality care 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 3Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 4
(Date:4/15/2014)... Biologists at UC San Diego have succeeded in ... hormone responsible for growth and resistance to drought. ... studies to determine how the hormone helps plants ... by the continuing increase in the atmosphere,s carbon ... achievement appears in the April 15 issue of ...
(Date:4/15/2014)... Looking at the question of how social behavior has ... universities in Mainz and Basel have gained new insights ... simply compete for food. Rather the siblings share what ... absent," explained Dr. Jol Meunier of the Evolutionary Biology ... University of Mainz (JGU). The team of biologists from ...
(Date:4/15/2014)... (April 15, 2014) The American Association of Anatomists ... All awards will be presented during the Closing ... Hotel on Tuesday, April 29th at 7:30 p.m. during ... , The 2014 award winners are: , ... PhD, of the Icahn School of Medicine at Mount ...
Breaking Biology News(10 mins):Biologists develop nanosensors to visualize movements and distribution of plant hormone 2Sibling cooperation in earwig families gives clues to early evolution of social behavior 2American Association of Anatomists 2014 award winners 2
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