AANMA Provides Commentary to FDA Advisory Committees Reviewing Benefit-Risk Assessment of 12 Hour Bronchodilators
FAIRFAX, Va., Dec. 11 /PRNewswire-USNewswire/ -- Nancy Sander, president and founder of Allergy & Asthma Network Mothers of Asthmatics (AANMA) today urged committee members to preserve patient access to all forms of 12-hour bronchodilators at a joint meeting of the Pulmonary-Allergy Drugs Advi...
FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)
PALO ALTO, Calif., Dec. 7 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (Nasdaq: CVTX ) announced today that the U.S. Food and Drug
Administration (FDA) has notified the Company that it will evaluate the
approval of potential anti-arrhythmic claims for Ranexa(R) (ranolazine
Thomson Scientific Publishes its Third Quarter Issue of the Ones to Watch Reviewing the Most Promising Drugs in the Pharmaceutical Pipeline
Novartis Leads the Drug List With its Alzheimer's Disease Treatment Exelon TDS
PHILADELPHIA, Nov. 30 /PRNewswire-FirstCall/ -- Thomson Scientific,
part of The Thomson Corporation (NYSE: TOC ; TSX: TOC) and leading provider
of information solutions to the worldw...
InstaCare Corp. Reviewing M&A Plans
Board to Consider Proposals and Variations
LOS ANGELES, Sept. 26 /PRNewswire-FirstCall/-- InstaCare Corp. (OTC
Bulletin Board: ISCR) a leading e-health Wi-Fi PDA technology provider, the
developer of proprietary technologies for medical DME and EMR applications,
and the distribu...
FDA To Reconsider Standards for Reviewing Low-Dose Oral Contraceptives
FDA in documents released Thursday announced it is reconsidering its standards for reviewing
the failure rate of new oral contraceptives with lower doses// of estrogen and progestin, the Wall Street Journal reports.
According to the Journal, higher pregnancy rates in studies of new low-dose o...
AlloSource Chosen as Healthcare Finalist in 2009 'Top Companies'
... the program for 10 consecutive years. Deloitte has been a Top Company sponsor for 9 years, and is responsible for administering the awards program by reviewing
all nominations and selecting three finalists from each category.
AlloSource delivers powerful possibilities to the med...
York Hospital Trauma Center Upgrade
... Services Act (Act 1985-45). The PTSF is the organization responsible for accrediting trauma centers in the Commonwealth of Pennsylvania. It has been reviewing
and surveying applicant hospitals since May of 1986.
Trauma centers are hospitals with resources immediately available to provide efficient s...
On the Heels of the Summer Meeting of the American Academy of Dermatology, Leading Dermatologist Weighs in on Sun Protection Myths and Facts
...rrently on the market, choosing the most effective one can be confusing. Remember -- SPF only measures UVB protection, not UVA. The FDA is currently reviewing
labeling guidelines that would indicate levels of UVA protection; but a final decision has not yet been made. In the meantime, consumers should look ...
Landauer, Inc. Reports Fiscal 2009 Third Quarter Results
...d from time to time to write down the value of assets or otherwise cause the Company to incur unanticipated expenses. You can find more information by reviewing
the "Risk Factors" section in the Company's Annual Report on Form 10-K for the year ended September 30, 2008, and other reports filed by the Company f...
Warner Chilcott Announces Receipt of Paragraph IV Certification Notices
...duced by the Company during the second half of 2006, is protected by U.S. Patent No. 6,667,050 which expires in 2019.
The Company is currently reviewing
the detail of the Paragraph IV Certification Notices from Lupin and continues to have full confidence in its intellectual property protecting LOESTRIN...
Reviewing in Medical Technology
FDA Reviewing Biomoda Submission for Cancer Screening Study
ALBUQUERQUE, N.M., Aug. 4 /PRNewswire-FirstCall/ -- Biomoda, Inc. (OTC
Bulletin Board: BMOD) ( http://www.biomoda.com ), a development stage medical
diagnostics company, submitted to the FDA a pre-IDE (Investigational Device
Exemption) protocol for a clinical study using Biomoda's proprietary ...
Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
...e are very encouraged by the overall strength of the data, which we will present in a scientific forum later this year. We are also looking forward to reviewing
the results of a final SRE study, in patients with advanced prostate cancer, next year."
Bone metastases, the spread of tumors to the bone, are...
FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia
... While the FDA is not bound by the committee's recommendations, the agency carefully considers them before making a final decision on approval. After reviewing
the SAPHRIS data, the committee voted in favor of SAPHRIS as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) f...
Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases
...tance of the RANK Ligand pathway in bone disease, and offer the promise of improved care for patients with advanced breast cancer. We look forward to reviewing
the results from a second Phase 3 study of denosumab effects in advanced cancer patients later this year."
Bone metastases, the spread of tumors ...
Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy
...tinguished physicians and scientists is available for playback at the following site:
supporting pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (nearly 400 patients), a panel of...
Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease
...commended primary analysis is a comparison of outcomes between the Amigal and ERT groups using descriptive statistics.
Amicus and Shire HGT are reviewing
the final EMEA feedback and will provide an update regarding plans for registration in Europe in the second half of 2009.
NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
...h concentration capsaicin dermal patch for the management of neuropathic pain in patients with postherpetic neuralgia (PHN).
The FDA is currently reviewing
the Company's new drug application (NDA) for Qutenza in PHN and has assigned a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009. Qutenza...
Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program
...icant clinical benefit for metastatic patients, given the very poor options available now for this substantial patient population. We look forward to reviewing
these results with FDA and their European and Japanese counterparts before determining the forward path for this promising drug."
Journal of American College of Cardiology Article Reports Fewer Repeat Procedures With Boston Scientific's TAXUS(R) Liberte(R) Stent
...Corporation (NYSE: BSX ) today welcomed the publication of an article in the current edition of the Journal of American College of Cardiology (JACC) reviewing
data on more than 19,000 patients from the Swedish national registry who were evaluated for restenosis, or the re-narrowing of arteries after percutan...
Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes
...the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing
new drug applications.
On April 3 at 8am CET, corresponding to 2am EDT, a conference call for investors will be held. Inve...
Reviewing in Medical Products
Inspirex Sleep System
Description:...or as an ambulatory recorder. Its small size and weight make it comfortable for every patient population and its high signal quality make reading and reviewing
the data easy. Trex has 32 input channels and an optional oximeter. It runs on 2 AA batteries and can transfer 24 hours of data to a PC in less than...
DV2000 Digital Imaging
Description:...le interface allows easy navigation and review of patient results and direct access to all functionality at all times. Swap from image manipulation to reviewing
test results or editing patient details with a single mouse click. Multiple images can be displayed with a wide variety of options including thumbnail...
Company:Medmont Pty. Ltd.
M700 Automated Perimeter
Description:...ice. The explorer style interface allows easy navigation and review of patient results and direct access to all functionality at all times. Swap from reviewing
test results or editing patient details with a single mouse click. Multiple image maps can be displayed with a wide variety of options and map types. ...
Company:Medmont Pty. Ltd.
MicroLux® Digital Video Recorder
Description:...ery into life-like presentations. With its convenient mouse and footswitch, you can record only the parts of the procedure you need - no more hours of reviewing
video tapes. With your finished DVD, you can transfer your digital files into your PC presentation....
Description:...le computer. This split screen mode helps create a work station environment allowing an individual with low vision to view magnified images while also reviewing
information from their computer....
Concise Guide to Drug Interaction Principles for Medical Practice
Features:...ology, psychiatry, and pain medicine Chapters on practical matters: prescribing guidelines, how to identify drug interaction patterns, strategies for reviewing
the current literature, and medicolegal concerns With Skyscape's patented smARTlink technology, PsychIx can easily cross-index with othe...
S/5 Arrhythmia Workstation
Features:...tients on the same screen (S/5 ARRWS telemetry option is not available in the USA or Canada)
Easy to use
Enhanced reporting and printing
of stored information ...
Easy II EEG
Features:... Synchronous Digital Video Long-term monitoring up to 72 hours at 30 frames per second Reader reviewing
software: On-line event log Can select specific segments to be
archived Screen splits for viewing multiple records or different segments of same ...
Company:Cadwell Laboratories, Inc.
Reviewing in Medical Definition
Anthrax Vaccine Immunization Program
...e-issued a Final Rule & Order  on the license status of the anthrax vaccine, clearing the way for mandatory vaccination reinstatement. After reviewing
extensive scientific evidence and carefully considering comments from the public, the FDA again determined that the vaccine is licensed for the preven...
Reviewing in Medical Dictionary
...T, Outpatient Parenteral Antimicrobial Therapy ... The term outpatient parenteral antimicrobial therapy (OPAT) is used to describe ... After reviewing
the Parenteral Nutrition handout, including use of all ... List the different types of parenteral protein, dextrose, and fat solutions for feedi...
...you notice: ... PATELLAR DISLOCATION ( DISLOCATED KNEE CAP) AND PATELLAR INSTABILITY ... Please review the section on knee anatomy prior to reviewing
this section. ... Bupa health factsheet - a dislocated kneecap and meniscus is a dislocation of the knee cap often caused by sports injur...
Basal cell carcinoma
... The different forms of basal cell carcinoma , man's most common skin cancer, will ... Aim of the basal cell carcinoma section: After reviewing
this chapter the reader ... Basal cell carcinoma tends to be slow growing. ... After treatment, basal cell carcinoma can recur (come b...
Reviewing in Biological News
Recovery act-funded research projects aid communities across the country
...pital equipment. Universities are helping researchers apply for ARRA funding and the federal science agencies tasked with distributing that money are reviewing
tens of thousands of grant applications all in a compressed timeframe and under new reporting requirements. As a result, in every state and the Dist...
Scientific evidence of health problems from past contamination of drinking water at Camp Lejeune is limited and unlikely to be resolved with further study
...rmine the levels of exposure at Camp Lejeune was complex, because people could have been exposed at home, school, daycare, or work.
In addition to reviewing
the studies focusing specifically on Camp Lejeune, the committee examined data on exposures and available scientific research on associations between ...
Combating Terrorism with Commercial Technology: 2009 Force Protection Equipment Demonstration
...bombing at Khobar Towers, in Saudi Arabia, in 1996. He determined there was a need to stay abreast of new counter-terrorism technology by periodically reviewing
new or improved equipment available for immediate purchase and employment. The Force Protection Equipment Demonstrations respond to that need and have...
Roberta A. Pagon receives lifetime award in genetics from March of Dimes
...t professor in the University's departments of ophthalmology and medicine. Her clinical work focuses on genetic eye diseases and syndrome delineation reviewing
the symptoms of patients who do not have a diagnosis to see if there might be a new disorder.
"Dr. Pagon is responsible for sharing critical inform...
Lombardi research: Monoclonal antibodies primed to become potent immune weapons against cancer
...eld. His co-authors are Madhav Dhodapkar, MD, of Yale University and Soldano Ferrone, MD, of the University of Pittsburgh.
Their analysis, based on reviewing
the last eight years of research on monoclonal antibody treatment, suggests that a new era in use of these therapies is just around the corner. "Scien...
Tracking tigers in 3-D
...y and K. Ullas Karanth all of the Wildlife Conservation Society's India Program.
Researchers currently calculate tiger populations by painstakingly reviewing
hundreds of photos of animals caught by camera "traps" and then matching their individual stripe patterns, which are unique to each animal. Using a f...
Famous fossil Lucy scanned at the University of Texas at Austin
...g Lucy was the easy part," Ketcham said. For the next several months, the research team, consisting of scientists from all around the country, will be reviewing
and processing the data and generating images to analyze Lucy's skeleton and begin to answer important questions ranging from whether she climbed amon...
ABC publishes monograph on scientific and clinical research of Sinupret
...ren," he added. The Food and Drug Administration advised parents not to administer cold and flu remedies to young children under 2 years of age and is reviewing
the safety of such products for older children. A leading OTC drug industry trade association has recommended that parents not administer such product...
MIT researchers explain mystery of gravity fingers
...data produced by the new mathematical model with observed phenomena, the two realized they'd found the solution, a solution described by one scientist reviewing
the paper in Physical Review Letters as "simple and elegant" and a "major breakthrough" in the field.
The Cueto-Felgueroso and Juanes solution al...
Researchers learn that some 'good cholesterol' isn't good enough
...tected from heart problems and should ask their doctor to find out whether their HDL is good or bad."
The researchers came to this conclusion after reviewing
published research on this subject. In their review, they found that the HDL from people with chronic diseases such as rheumatoid arthritis, kidney di...
Reviewing in Biological Technology
Angiotech Pharmaceuticals, Inc. announces financial results for the second quarter ended June 30, 2009
.... In May 2009 we announced that our partner BSC had welcomed the publication of an article in the Journal of the American College of Cardiology (JACC) reviewing
data on more than 19,000 patients from the Swedish national registry who were evaluated for restenosis, or the re-narrowing or arteries, after percuta...
Cardium Announces New Orthobiologics Product Initiative Extending Gene Activated Matrix Technology to Deliver Bone Growth Factors
...orphogenetic protein market with over 90% of the U.S. sales totaling $815 million in 2008. A recent Journal of American Medical Association article reviewing
the use of bone morphogenetic proteins in spinal fusions estimated that in 2006 approximately 25% of spinal fusion procedures utilized a BMP product t...
Cardiogenesis Corporation Makes Pre-IDE Submission for PHOENIX Combination Delivery System
... applications for its angiogenic effect and accelerated wound healing response.
Center for Biologics Evaluation and Research (CBER) is the lead reviewing
center for the PHOENIX application. The company expects to meet with CBER during the next 60 days to identify any additional information required to ...
Cardium Provides Update on Phase 2b Excellarate Clinical Study and Plans for Additional Tissue Repair Applications
... trial, we have observed some remarkable healing responses as reported in the media by our medical centers from around the nation. We look forward to reviewing
the MATRIX study's complete unblinded data set and to outlining our plans not only for this product candidate but potentially other product candidates...
Kansas Delegation Defends NBAF, Refutes Washington Post
The Department of Homeland Security approved locating the new National Bio and Agro-Defense Facility in Manhattan, Kansas, after reviewing
18 possible sites over 6 years. NBAF will be dedicated to researching the biological threats of foreign animal diseases and diseases transferred from ...
OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer
...nd cannot be changed after the clinical trial begins except: (i) with written agreement of the company and the FDA; or (ii) if the director of the FDA reviewing
division determines that "a substantial scientific issue essential to determining the safety or effectiveness of the drug" was identified after testin...
Virtify, Inc. Delivers Industry's First Enterprise Content Compliance Software Suite for Life Sciences Companies
..., and re-use - virtually eliminating inconsistencies and redundancies enterprise-wide. Virtx tailors upstream functions, such as content authoring and reviewing
to meet electronic requirements and standards, while automating downstream functions such as assembly, publishing, delivery and archiving.
NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)
...esthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program.
The FDA is currently reviewing
the NDA for Qutenza in PHN, which has a Prescription-Drug User Fee Act (PDUFA) date of August 16, 2009. The marketing application is supported by clin...
Plenish™ High Oleic Soybean Oil Offers Trans Fat Solution with Superior Performance
...dministration completed its review of Plenish™ high oleic soybeans earlier this year and the U.S. Department of Agriculture is in the process of reviewing
the trait. Regulatory submissions for the trait are planned or have been completed in key soybean importing countries around the world.
Phosphagenics Announces Completion of Transdermal Patch Prototypes
...unt and duration of oxycodone delivered into the systemic circulation, and could reduce potential opioid abuse, a major consideration for the FDA when reviewing
possibly addictive substances such as oxycodone. In addition, our TPM skin patch should allow us to deliver other opioid based compounds, including mo...
Reviewing in Biological Dictionary
... estheticians are online for free acne advice. Scar removal, scar treatment, scar healing, scar management, scar therapy, ... scarring , reviewing
all the studies and literature on available scar treatments, ... scar treatment, ... and Re-seller Programs for Scar Treatment. 24/7 Phone Or...
... This timely book brings together all of the key recent research on this disparate group of viruses , providing for the first time a single resource reviewing
dsRNA ... Double-stranded RNA viruses . Retroviruses. Latent Viruses . Lysogeny. Transduction. Viruses ... Either DNA or RNA , never both. D...
...es ... experiments, Mendel developed several fundamental laws of Mendelian inheritance . ... Mendelian Inheritance . Introduction. Concept 1: reviewing
Mendel's Laws. Concept 2: The Arrival ... case, the modes of inheritance for the genes involved will ... ...
...alled the nucellus ... BSA Plant Images Online - Lilium ovule m.l.s. showing integuments, nucellus, micropyle, megasporocyte ... A Strategy for reviewing
Books for Journals ... ...