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ZEFTERA, A New Anti-MRSA Broad-spectrum Antibiotic Approved By Health Canada

ZEFTERA has been approved by Health Canada for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb-threatening diabetic foot infections without concomitant osteomyelitis. This approval makes ZEFTERA the only approved antibiotic in its class (cephalosporin) to demonstrate efficacy against Methicillin-resistant Staphylococcus aureus (MRSA), a growing public health concern in both hospital and community settings.

SyntheMed Announces FDA Clearance Of SinusShield(TM)

SyntheMed, Inc. (OTC Bulletin Board: SYMD) announced that it has received FDA 510(k) clearance to market SinusShield(TM), a bioresorbable membrane intended to prevent post-operative adhesions in nasal and sinus surgical procedures. There are approximately two million nasal and sinus procedures performed annually in the United States. Robert P.

GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix Until End Of 2009

GlaxoSmithKline on Monday said it does not expect to receive FDA approval for its human papillomavirus vaccine Cervarix until late 2009, Reuters reports. GSK said it has decided to wait until results from a Phase III trial of the vaccine are available before seeking U.S. approval.

Volunteers Respect Accurate and Personalized Information From Study Results

Many CROâ€™s and investigators believe that even though volunteer patients in clinical trials expose themselves to a great deal of risk, there is no legal mandate for investigators to inform them of study results

Half Of Trials Supporting FDA Applications Go Unpublished

Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine. The most important trials determining efficacy, and those with statistically significant results and larger sample sizes, are more likely to be published.

Chinese SFDA Approves Helicon's (ASX:HCG) ReCell(R) Concept And Kit - Skin Regeneration Concept And Device

Helicon Group Limited (ASX:HCG) is pleased to announce that earlier this month the Chinese State Food and Drug Administration (SFDA) granted approval for the skin regeneration concept and device, ReCell(R), for sale in China. The approval process for the product has been complicated and intensive due in part to the pioneering nature and complexity of the ReCell(R) kit. Importation issues with some components of the kit are being resolved with the SFDA.

FDA Approves Expanded Uses For Gardasil To Include Preventing Certain Vulvar And Vaginal Cancers

The U.S. Food and Drug Administration announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.

Anestvice Inc. Phase II Clinical Trials for PC-LM Device have been successfully completed.

The research was conducted on 24 patients ranging in age from 13 to 74 years (the average age was 46.6 Â±5.4), who underwent surgery in the urology clinic of the Rostov State Medical University. It was sponsored by Anestvice Inc...

HHS Opens Offices Of The Food And Drug Administration (FDA) In China

As part of an ongoing strategy to continually improve import safeguards to meet the changing demands of a global economy, the U.S. Department of Health and Human Services (HHS) is this week officially opening offices of its Food and Drug Administration (FDA) in Beijing, Guangzhou and Shangai in the People's Republic of China. HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach, M.D.

Talecris Biotherapeutics Receives Orphan Drug Designation For Aerosolized Form Of Alpha1-Antitrypsin (AAT) From The European Commission

Talecris Biotherapeutics, Inc. announced today that the European Commission followed an opinion of the Committee for Orphan Medicinal Products (COMP) and has granted orphan drug designation to Talecris' alpha-1 proteinase inhibitor (human) for inhalation use in the treatment of congenital Alpha1-Antitrypsin Deficiency (also known as AAT Deficiency or Alpha-1). Currently, there are no approved aerosolized treatments available for augmentation therapy for AAT Deficiency.

Antibiotic-Resistant Organisms Could Be Spread By The Transporting Of Broiler Chickens

Researchers at the Johns Hopkins Bloomberg School of Public Health have found evidence of a novel pathway for potential human exposure to antibiotic-resistant bacteria from intensively raised poultry - driving behind the trucks transporting broiler chickens from farm to slaughterhouse.

CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published

A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof.

Crystalens HDT Receives FDA Approval

Bausch & Lomb announced that it has received approval from the Food and Drug Administration (FDA) to market the Crystalens HDT in the United States. Crystalens accommodating intraocular lens (IOL) was first approved by the FDA in November 2003. The Crystalens HD is the fourth generation of the only FDA approved accommodating lens. The surface of the Crystalens HD has been shaped to enhance the depth of focus with a proprietary optical modification.

Earlier-stage, Localized Renal Cell Carcinoma - Antigenics Submits Oncophage(R) Application For European Approval

Antigenics Inc. (NASDAQ: AGEN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting approval for Oncophage® in earlier-stage, localized renal cell carcinoma (kidney cancer) under the conditional authorization provision. Currently, there are no EMEA-approved drug therapies for this patient population.

FDA Updates Health Information Advisory On Melamine Contamination

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States.

Pharmalef Developments is a home for team-oriented professionals

Pharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party

FDA Approves Boston Scientific's Express(R) SD Renal Stent System

Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the Express® SD Renal Monorail® Premounted Stent System for use as an adjunct to PTRA (percutaneous transluminal renal angioplasty) in certain lesions of the renal arteries. The Express SD System is the first low-profile, pre-mounted stent approved for use in renal arteries in the United States.

Toxic Drugs, Toxic System: Sociologist Predicts Drug Disasters, Says Prescription Drug Harm Growing, Drug Testing, Approval And Marketing Flaws

Toxic drugs, toxic system: Sociologist predicts drug disasters, says prescription drug harm growing, drug testing, approval and marketing flaws Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs such as Vioxx in the future because of fatal flaws in the way new drugs are tested and marketed, according to research to be presented today at the annual meeting of the American Sociological Association (ASA).

Postmarketing Studies Are Becoming The Norm In The U.S., Europe, And Japan, According To Tufts Center For The Study Of Drug Development

Post-approval study commitments, in which drug developers, as a condition of regulatory approval, agree to conduct research on newly marketed prescription drugs, are becoming routine in the United States, Europe, and Japan, according to a recently completed analysis conducted by the Tufts Center for the Study of Drug Development. Seventy-five percent of new drugs approved in the U.S.

Clinproxy believes in the concept that cooperation with other CROs is the key to unlocking great accomplishments in the biopharmaceutical research industry.

Clinproxy is a Contract Research Organization www.clinproxy.com that is attempting to change the idea that has overwhelmed the Biopharmaceutical Industry, that for a company to survive it had to exist in competition with all others.

FDA Wants Suicide Warnings On Epilepsy Drugs

A panel of independent experts that advises the US Food and Drug Administration (FDA) is meeting this Thursday in Beltsville, Maryland, to review evidence of increased suicide risk for patients on anti-seizure drugs, and is expected to agree to the FDA's recommendation that these drugs carry the highest level of warning, the so-called "Black Box" label.

FDA Approves Drug That Boosts Stem Cell Yield For Bone Marrow Transplants

The U.S. Food and Drug Administration approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin's lymphomas.

APP Pharmaceuticals Receives Final Approvals For Additional Dosages Of Granisetron Hydrochloride Injection, USP

APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received final approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril® Injection.

Limdatoâ€™s Grasp On Streamlining Clinical Trials

Limdato, www.limdato.com understands that executing a successful clinical trial requires a seamless coordination and communication with all individuals involved on levels on the trial

FDA Advises Against Consumption Of American Lobster (Maine Lobster) Tomalley

The U.S. Food and Drug Administration warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). American lobster, also known as Maine lobster, are harvested from the waters of the Atlantic Ocean from Northeastern Canada to South Carolina, inclusive.

Elekta Receives CE Mark Clearance For 'Everyday Radiation Therapy' Accelerator, Elekta Compact

Elekta recently announced that it has received CE Mark clearance to distribute Elekta Compact(TM), the latest addition to its line of treatment systems, offering clinicians an easy to implement, more affordable solution for radiation therapy. CE Mark clearance from the European Union certifies Elekta Compact has met health, safety and environmental requirements for consumer safety.

New HIV/AIDS Treatment SELZENTRYT Becomes The Latest Fully Approved Antiretrovial For Treatment-Experienced HIV Patients

The U.S. Food and Drug Administration (FDA) has granted SELZENTRYT (maraviroc) full (traditional) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. SELZENTRY was originally granted accelerated conditional approval in August 2007 based on 24-week data from pivotal Phase 3 studies. SELZENTRY now becomes the latest fully approved treatment for HIV.

Espoir Bridge Recruiters has a well established database of over 60,000 candidates all over the world

Espoirbridge www.espoirbridge.com consultants have a wealth of knowledge and experience in Clinical Research, Data Management, Quality Assurance, Regulatory Affairs and all aspects of Information Technology and Office Support.

FDA Approves Drug For Patients With Advanced Prostate Cancer

The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.

Pioneer(R) Surgical Technology Receives 510(k) Clearance To Market FortrOss(TM), A Next Generation Bone Void Filler

Pioneer Surgical Technology, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market FortrOss, a novel bone graft substitute utilizing the power of nanotechnology for orthopaedic applications. The FortrOss bone void filler is a scaffold for the in-growth of new bone and other connective tissues, when superior bone regeneration is required.

ViroPharma Provides Update On Upcoming FDA Advisory Committee Meeting To Discuss Bioequivalence Of Locally Acting Gastrointestinal Drugs

ViroPharma Incorporated (Nasdaq: VPHM) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin(R) (vancomycin hydrochloride capsules) or any other drug products.

Compliance in Developing countries is a balancing act

Clinproxyâ€™s, www.clinproxy.com global spread continues to acknowledge to issues with regards to developing countries and the compliance required for clinical trials.

AZILECT(R) Shown To Be A Selective MAO-B Inhibitor - Teva To Work With FDA To Modify The Azilect(R) Label

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results of a study in which Azilect® (rasagiline tablets) demonstrated selective MAO - B inhibition at the approved dose of 1mg. Non selective MAO inhibitors may have some contra indications with certain foods and drugs. These limitations are not associated with selective MAO inhibitors and therefore they can be broadly prescribed. Based on these positive results, Teva will work with the U.S.

EU Grants VIDAZA® Full Marketing Authorization For The Treatment Of Patients With Higher-Risk Myelodysplastic Syndromes And Acute Myeloid Leukaemi

Celgene International SÃ rl (Nasdaq:CELG) today announced that its cancer drug, VIDAZA (azacitidine), has been granted full marketing authorization by the European Commission for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with: -- I

Expert Says Eshoo-Barton Bill Stifles Drug Innovation, USA

Pending legislative proposals in Congress to create a follow-on biologics (FOBs) pathway risk overextending monopoly protection and undermining innovation, according to a comprehensive analysis released today by Boston University Economics Professor Laurence J. Kotlikoff and commissioned by Teva Pharmaceuticals USA. Dr.

The Cerebroprotective Properties of Cereprotex (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) after traumatic and hypoxic brain injury

The cerebroprotective effect of Cereprotex (Patent pending â€“ Cereprotec Inc. www.cereprotec.com ) (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) , previously known as (CombiCNS1), was assessed in a model of closed head injury in mice...

EonC, The First Extended-Life Primary Cell Neurostimulator For The Treatment Of Chronic Pain Approved In USA And Europe

St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of EonCT, the first extended-life primary cell (non-rechargeable) neurostimulator for the treatment of chronic pain. The EonC neurostimulator provides a convenient option for chronic pain patients who prefer or require the simplicity of a non-rechargeable medical device.

EpiCept Receives Ceplene(R) Marketing Approval In Europe

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that the European Commission has granted a full marketing authorization in the form of a positive Commission Decision, for Ceplene® (histamine dihydrochloride) for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2).

FDA Approves DNA Test To Measure Hepatitis B Virus Levels

The U.S. Food and Drug Administration approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections. The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum.

Use of the Cereprotex prior to and after the CABG procedures to substantially reduce or eliminate the effects of neuro-impairment.

Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment...

GlaxoSmithKline Responds To FDA On CERVARIX(R) And Plans To Submit Final Study Data For Approval

GlaxoSmithKline (NYSE: GSK) provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX(R), its vaccine to prevent cervical cancer. GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007.

FDA Approves Boston Scientific's ApexT PTCA Dilatation Catheter

Boston Scientific Corporation (NYSE: BSX) today announced that it has received approval from the U.S. Food and Drug Administration to market its ApexT PTCA(1) Dilatation Catheter. The Apex Catheter is a high-performance pre-dilatation balloon catheter developed specifically to address physicians' needs in treating the most challenging atherosclerotic lesions. It is available for distribution in both Monorail® and Over-The-Wire (OTW) catheter platforms.

FDA Approves First Generic Divalproex Sodium To Treat Seizures, Migraine Headaches And Bipolar Disorder

The U.S. Food and Drug Administration approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. "Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," said Gary J.

The Birth of the Profession of Clinical Research Associate

According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionalsâ€”Clinical Research Associates, also known as Clinical Monitors.

FDA Grants Conditional Approval To Interventional Spine's PercuDynT System IDE Application

Interventional Spine, Inc. announced that the U.S. Food and Drug Administration has approved the Company's investigational device exemption (IDE) application for its PercuDyn System for the treatment of degenerative disc disease (DDD). This approval is conditional upon the Company providing some additional information to the FDA. Walter A. Cuevas, Interventional Spine's CEO, observed, "We are pleased by FDA's action.

FDA Approves New Huntington's Drug

The US Food and Drug Administration (FDA) announced on Friday that it has approved Prestwick Pharmaceuticals Inc's new drug Xenazine (generic name tetrabenazine) for the treatment of chorea in people with Huntington's disease, heralding the first treatment to receive US approval for any of the disease's symptoms. Huntington's is a rare inherited neurological disorder characterized by chorea or jerky, uncontrolled movements.

Pro-Pharmaceuticals Submits Data For Registration Of DAVANAT(R) To Treat Late-Stage Colorectal Cancer Patients

Pro-Pharmaceuticals, Inc. (AMEX: PRW), a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds to treat cancer, has submitted supporting clinical and manufacturing data to the U.S. Food and Drug Administration (FDA) for a New Drug Application (NDA) registration of DAVANAT®, a new chemical entity, for the treatment of advanced colorectal cancer.

Skyrocketing growth of the CRO market

The combination of the growing trend by pharmaceutical companies to outsource a wider range of services, and the need to pass products through the testing and regulatory process in a rapid

Protecting Consumers When Drug Manufacturers Fail To Warn Patients About Known Health Risks

Attorney General Martha Coakley's Office joined Vermont and 45 other states in filing an amicus curiae brief with the U.S. Supreme Court arguing that states should have the power to protect consumers when drug manufacturers fail to warn patients about known health risks. The brief, filed last week, argues that Congress did not intend to supersede longstanding state laws that protect consumers and require adequate labeling of risks associated with pharmaceuticals.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application To FDA For Rivaroxaban

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery. In 2005, J&JPRD entered into an agreement with Bayer HealthCare AG to jointly develop rivaroxaban.

Mckenna Long & Aldridge Assists New York's Northern Metropolitan Hospital In A Groundbreaking Filing To Be A Patient Safety Organization

New York's Northern Metropolitan (NorMet) Hospital Association today became the first in the country to file to become a Patient Safety Organization (PSO) with the US Department of Health and Human Services (HHS). PSO's are private entities recognized by the Secretary to collect and analyze patient safety events reported by physicians and other healthcare providers.

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial.

Genta To Appeal FDA Decision On New Drug Application For Genasense(R) In Patients With Chronic Lymphocytic Leukemia

Genta Incorporated (OTCBB: GNTA.OB) announced that the Company has filed an appeal of the recent negative decision by the Food and Drug Administration's (FDA) Office of Oncology Drug Products (OODP) regarding the Company's New Drug Application (NDA) for Genta's lead oncology product, Genasense® (oblimersen sodium) Injection. The NDA proposed the use of Genasense in combination with chemotherapy as treatment for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

FDA Panel Recommends Approval Of New, Less Costly Female Condom

An FDA advisory panel on Thursday voted 15-0 to recommend approval of the new, less costly version of the female condom developed by the Female Health Company, Reuters reports.

PLX-PAD Could Become An Effective Therapeutic Alternative For Diabetics, Smokers And Others Who Are At Risk Of Amputation

Pluristem Therapeutics Inc. (Nasdaq:PSTI)(DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today the successful conclusion of its pre-clinical efficacy studies utilizing PLX-PAD prior to the initiation of human clinical trials.

What Clinical Research Is All About

How can researchers prove to the government that a newly-discovered drug or device is safe and effective? This is where the clinical trial comes in. The clinical trial is a research study designed to determine if a new pharmaceutical or medical device is sufficiently safe and effective for human use.

UCB's Vimpat® Approved By U.S. FDA As Adjunctive Therapy For Partial Onset Seizures In Adults

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Vimpat® (lacosamide), a new antiepileptic drug (AED). Vimpat® is for use as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older. "Having a new antiepileptic drug option may offer adults with partial onset seizures the chance to obtain seizure control.

FDA Requires New Safety Measures For Oral Sodium Phosphate Products To Reduce Risk Of Acute Kidney Injury

The U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures.

FDA Approves 2008-2009 Season's Flu Vaccines

The US Food and Drug Administration (FDA) has approved this year's seasonal flu vaccine, including new strains that are likely to be circulating in the US; the agency released the news on its website Tuesday. The vaccines will be made by six manufacturers: CSL Limited, Afluria. GlaxoSmithKline Biologicals, Fluarix. ID Biomedical Corporation of Quebec, FluLaval. MedImmune Vaccines Inc., FluMist.

Clinproxy is a CRO with a focus on the Investigator with aspects essential for validating a drugâ€™s remedial benefits.

FDA Licenses For Marketing New Therapy For Rare Genetic Disease

The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease.

UCB's VimpatTM Recommended For Approval In Europe For Epilepsy

Regulated information UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grants a marketing authorisation for lacosamide, proposed trade name VimpatT, for the adjunctive treatment of partial onset seizures with or without secondary generalisation in patients with epilepsy, aged 16 years and older.

Requiring Animal Research To Be More Evidence-based'

It is generally believed by the public that animal research is only carried out providing: a) it leads to improvements in human health b) non-animal models and technologies are unavailable c) it is not duplicated unnecessarily d) it is not done for trivial and non-medical reasons e) it cannot be conducted ethically in humans f) suffering of laboratory animals is minimised.

Limdato: Patient recruitment is essential to the accelerated success of a clinical trial.

Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsorâ€™s budget.

Alkermes Announces Approval Of VIVITROL(R) For The Treatment Of Alcohol Dependence In Russia

Alkermes, Inc. (NASDAQ: ALKS) announced that its partner, Cilag GmbH International, a subsidiary of Johnson & Johnson, received approval from the Russian Regulatory Authorities to market VIVITROL® (naltrexone for extended-release injectable suspension) for the treatment of alcohol dependence in Russia. The product will be manufactured by Alkermes and commercialized by Janssen-Cilag, an affiliate company of Cilag GmbH International.

FDA Clears Neurostar® TMS Therapy For The Treatment Of Depression

Neuronetics, Inc., a privately-held medical device company and a leader in the field of neuromodulation, announced today that the U.S. Food and Drug Administration (FDA) has cleared its NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system for the treatment of depression.

FDA Statement Following CHPA's Announcement On Nonprescription Over-The-Counter Cough And Cold Medicines In Children

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines.

The Cerebroprotective Properties of Cereprotex (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) after traumatic and hypoxic brain injury

Vitrolife: New Unique Product Approved In Europe - New Needle For The Collection Of Human Oocytes

Vitrolife (STO:VITR) has received European approval, a so-called CE mark, for its new needle for the collection of human oocytes, Swemed SenseT (patent pending). The needle, which is under launch, has received a very positive response and very positive publicity.

MEDRAD Receives FDA 510(k) Clearance For Wireless MR Infusion System

MEDRAD, INC., announced that the wireless version of its Continuum MR Infusion System has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The new Continuum Wireless MR Infusion System enables the clinician to control a patient's medication infusion during a magnetic resonance (MR) procedure from both inside and outside the scan room.

FDA Approved Use Of REYATAZ(R) Boosted With Ritonavir, In Combination Therapy, For Previously Untreated HIV-1 Infected Adult Patients

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food & Drug Administration (FDA) approved the use of REYATAZ® (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in previously untreated (treatment-naive) HIV-1 infected patients. REYATAZ boosted with ritonavir (REYATAZ/r) taken once daily with food is recognized by the U.S.

Clinproxy: In general the overall expense of clinical trials depends on a multitude of factors

In an ever growing global market of supply and demand, it remains unimaginable to engage in practices that are ambitiously expensive when there are endless opportunities to utilize more appropriately priced methods which would in turn yield the same results. T

Wall Street Journal Examines Leader Of Obama's FDA Assessment Team, Potential Agency Heads

Joshua Sharfstein -- commissioner of the Baltimore City Health Department and a physician -- is leading President-elect Barack Obama's team to assess FDA, "boosting his chances of becoming" the agency's next commissioner," the Wall Street Journal reports.

VELCADE(R) (Black Triangle Drug) (bortezomib) Approved For Previously Untreated Multiple Myeloma, Europe

Janssen-Cilag / Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, announced the European Commission's approval of VELCADE in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma (MM) who are not eligible for high-dose chemotherapy with bone marrow transplant.

European CHMP Issues Positive Opinion On Cymbalta For The Treatment Of Generalised Anxiety Disorder

Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion supporting the approval of Cymbalta(R) (duloxetine hydrochloride) for the treatment of Generalised Anxiety Disorder (GAD).

Esploron CRO integrates business, science and industry expertise to develop innovative solutions.

Esploron www.esploron.com integrates business, science and industry expertise to develop innovative solutions that work! Although biotechnology and pharmaceutical companies are spending more on research and development, commercially viable innovations are decreasing.

Marketing Authorization Application For Lipsovir(R) Submitted To European Regulatory Authorities

Medivir (STO:MVIRB) has now submitted an application for marketing authorization to the European regulatory authorities for Lipsovir®, a topical product for prevention and treatment of cold sores. Lipsovir® is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) in a proprietary cream base developed by Medivir.

GSK Receives Positive Opinion For Alli(R) (orlistat 60 Mg) As A Non-prescription Weight Loss Aid In Europe

Thursday 23 October 2008, London GlaxoSmithKline (GSK) announced today that alli (orlistat 60 mg) has received a positive opinion as a non-prescription product from the Committee for Medicinal Products for Human Use (CHMP). This means the product will now be proposed for final approval by the European Commission and marketing authorisation could be granted in the coming months.

HIV - Intelence (Etravirine) Receives Positive Opinion From European Committee For Human Medicinal Products

Tibotec Pharmaceuticals, Ltd. announced today that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending conditional approval of its HIV medication INTELENCET (etravirine) in the European Union. Etravirine, also known as TMC125, is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and is the first new NNRTI to be introduced in approximately 10 years.

Primarily, problems arise between sponsors and CRO-s when there are fundamental breakdowns in the delegation of responsibilities

As per ClinQua Inc. www.clinqua.com relationships exist on all levels of clinical development. Primarily, problems arise when there are fundamental breakdowns in the delegation of responsibilities or rather when someone is given control over a critical area when they are otherwise unqualified.

PolyMedix Has Regulatory Clearance To Initiate Phase I Clinical Study Of Novel Anticoagulant Antagonist Compound

PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has clearance to start human clinical trials in the United States with its anticoagulant reversing agent PMX-60056 under the Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

UCB Receives U.S. FDA Complete Response Letter For Neupro(R) In Restless Legs Syndrome And Advanced Parkinson's Disease

UCB announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its transdermal patch, Neupro® (rotigotine transdermal system) to treat the signs and symptoms of advanced Parkinson's disease, and as a treatment for the signs and symptoms of moderate to severe primary Restless Legs Syndrome (RLS).

Duchenne Muscular Dystrophy - AVI-4658 Recommended For Orphan Drug Status In EU

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, today announced that the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending orphan medicinal product designation for AVI-4658 to treat Duchenne muscular dystrophy (DMD).

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

In a progressive global market of supply and demand, it remains unthinkable to engage in practices that are ambitiously over-priced when there are endless opportunities to utilize more cost-efficient methods which would yield the same results.

Relapsed Ovarian Cancer - Submitted New Drug Application To FDA For Trabectedin

PharmaMar announced today that Ortho Biotech Products, L.P. has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL® (pegylated liposomal doxorubicin) for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with DOXIL® will provide a new, non-platinum treatment option for these patients in the United States.

Cimzia(R) Filed With EMEA For Treatment Of Rheumatoid Arthritis, Europe

UCB announced that a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of Cimzia® (certolizumab pegol) as a subcutaneous treatment for adults with moderate to severe active rheumatoid arthritis (RA) and has been accepted for review. Subject to approval, Cimzia® will be the first and only PEGylated, Fc-Free anti-TNF (Tumour Necrosis Factor alpha) biologic therapy available in Europe for the treatment of RA.

FDA Special Protocol Assessment (SPA) For Expanded Indication Of LibiGel® In FSD For Female Sexual Dysfuntion

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it successfully has completed and reached an additional agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its LibiGel (transdermal testosterone gel) program in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in "naturally" menopausal women.

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner.

Dietary Supplements For Horses, Dogs And Cats Need Better Regulation

The growing use of animal dietary supplements has raised several concerns, including the safety of specific supplements and the approaches taken to determine their safeness. A new National Research Council report, requested by the Center for Veterinary Medicine of the U.S. Food and Drug Administration, assesses whether the addition of three dietary supplements -- lutein, evening primrose oil, and garlic -- to the diets of horses, dogs, or cats may cause significant adverse health effects.

Micrus Endovascular Receives Approval To Market Cerecyte Microcoils In Japan

Micrus Endovascular Corporation (Nasdaq: MEND) announced receipt of Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) to market in Japan its Cerecyte® microcoil product line, including the MicruSphere®, Presidio®, HeliPaq® and UltiPaq® Cerecyte embolic coils, for the endovascular treatment of cerebral aneurysms. Sales of the Company's Cerecyte microcoils will be managed by Goodman Co., Ltd.

Tracleer(R) (bosentan) Receives EU Approval For Treatment Of Patients With Mildly Symptomatic Pulmonary Arterial Hypertension

Actelion Ltd (SWX: ATLN) announced that Tracleer® (bosentan), a dual endothelin receptor antagonist, has been approved in the European Union for the treatment of patients with mildly symptomatic pulmonary arterial hypertension (PAH WHO functional class FC II). Since 2002, Tracleer® has been approved and available in the European Union for PAH patients with WHO FC III.

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial.

Lawmakers Debate Picks For FDA Chief; Possibilities Include Drug Safety Director Woodcock

Debate over whether any current FDA officials should be named as successor to current FDA Commissioner Andrew von Eschenbach and how quickly the decision should be announced is dividing congressional officials, "reflecting a divergence of views ... on how to fix the FDA's problems," the Wall Street Journal reports.

FDA Continues Review Of Takeda's New Drug Application For Alogliptin (SYR-322), A DPP-4 Agent For Type 2 Diabetes

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

TOVIAZT (fesoterodine Fumarate) Gets FDA Approval For Overactive Bladder Treatment

Pfizer Inc said that the U.S. Food and Drug Administration (FDA) approved TOVIAZT (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms. New once-daily TOVIAZ can significantly reduce the number of urge urinary incontinence episodes and the frequency of urination over 24 hours, symptoms of OAB that can significantly impact patients' lives.

Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.

With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individualâ€™s health care needs, developing a wide range of products.

Northfield Laboratories Inc. Announces Submission Of BLA For PolyHeme(R) - Human Hemoglobin-based Red Cell Substitute

Northfield Laboratories Inc. (Nasdaq: NFLD) announced today it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for PolyHeme®, the Company's human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available. Northfield also requested Priority Review, based on the potential for PolyHeme to address a critical, unmet medical need.

Cold Sores Prevention - New Drug Application (NDA) For Lipsovir® Submitted To US FDA

Medivir (STO:MVIRB) has today submitted an NDA to the US Food & Drug Administration (FDA) for Lipsovir®, a topical product for prevention and treatment of cold sores. Lipsovir® is a patented combination of hydrocortisone (an anti-inflammatory agent) and aciclovir (an antiviral agent) in a proprietary cream base developed by Medivir.

APRISOT Granted FDA Marketing Approval For Maintenance Of Remission Of Ulcerative Colitis

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for APRISOT (mesalamine) extended-release capsules 0.375 g. APRISO is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults. APRISO is the first and only mesalamine product approved by the FDA for once-a-day dosing for the maintenance of remission of ulcerative colitis.

What Clinical Research Is All About

Digestive Care, Inc. Announces The Filing Of The First Module Of NDA Submission For PANCRECARB(R) (pancrelipase)

Digestive Care, Inc. (DCI) announced that it has submitted the first module of its New Drug Application ("NDA") for PANCRECARB(R) (pancrelipase), used in the treatment of Exocrine Pancreatic Insufficiency ("EPI"), with the U.S. Food and Drug Administration ("FDA"). The FDA has granted the product Fast Track designation.

FDA Licenses Drug To Prevent Joint Damage In Children With Hemophilia A

The U.S. Food and Drug Administration has approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia. Hemophilia A is a rare, hereditary, bleeding disorder in which a protein needed to form blood clots, factor VIII, is missing or its level is reduced. The disorder affects about 15,000 individuals in the United States, nearly all of whom are male.

CleviprexT Receives FDA Approval - First New IV Antihypertensive Treatment Approved In Ten Years

The Medicines Company (NASDAQ: MDCO) announced that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy CleviprexTM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex, a novel IV antihypertensive, represents an advancement over currently available therapies, providing rapid and precise control of blood pressure in the critical care setting.

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

Janssen-Cilag International N.V. Withdraws Its Application For An Extension Of Indication For Invega (paliperidone)

The European Medicines Agency (EMEA) has been formally notified by Janssen-Cilag International N.V. of its decision to withdraw its application for an extension of indication for the centrally authorized medicine Invega (paliperidone) prolonged-release tablets. Invega was expected to be used for the treatment of acute manic episodes associated with bipolar I disorder. Invega was first authorised in the European Union on 25 June 2007.

NICE Citizens Council Report On Quality Adjusted Life Years (QALYs) And The Severity Of Illness Published, UK

A report from NICE's Citizens Council on Quality Adjusted Life Years (QALYs) and the severity of illness is now available on the NICE web site.

The FDA Has Accepted For Filing The Registration Application For Sublinox

The submitted registration application for Sublinox has been accepted by the FDA as complete for substantive review after initial evaluation. Sublinox contains the well-known active substance zolpidem and is based on Orexo's sublingual technology, involving a rapidly disintegrating tablet placed under the tongue. Meda AB acquired the exclusive world-wide commercialization rights for Sublinox on April 14, 2008.

Outsourcing of R&D functions is reshaping the drug development services industry.

As per Esploron www.esploron.com executive management the cost of drug development has soared during the past ten years compelling pharmaceutical and biotechnology companies to look for new, smarter ways of conducting clinical research.

Erbitux Receives CHMP Positive Opinion For 1st-Line Use In Head And Neck Cancer, Europe

Merck Serono, a division of Merck KGaA, announced today that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), to extend the use of the targeted therapy Erbitux® (cetuximab) to include 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

FDA Approves Nasacort AQ(R) Nasal Spray For Children Aged 2 - 5 Years Old

Sanofi-aventis announced the U.S. Food and Drug Administration (FDA) has approved Nasacort AQ Nasal Spray (triamcinolone acetonide) for children aged 2 - 5 years old for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

Vimpat(R) Approved In Europe - First New Epilepsy Treatment For Partial-Onset Seizures In Three Years

UCB announced that the European Commission (EC) has approved Vimpat® (lacosamide) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Vimpat® is the first new antiepileptic drug (AED) for partial-onset seizures in three years and offers a new treatment option for European patients living with uncontrolled partial-onset epilepsy.

Anestvice Pressure Controller (APC), is build to maintain the pre-set constant pressure in the cuff throughout the surgery despite of the factors influencing and/or altering this parameter.

Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) ...

FlowMedica Inc. Receives FDA Clearance For New Indication For The Benephit® Infusion Systems

FlowMedica Inc., a medical device company pioneering targeted renal therapy (TRT®), announced today that it has received FDA clearance for a new labeling indication for the Benephit® Infusion Systems. The system can now facilitate TRT in patients who have demonstrated symptoms of or are at risk of developing Acute Kidney Injury (AKI). TRT is the direct delivery of physician-specified medications and other therapeutic agents into the kidneys via the renal arteries.

FDA Approves Software Update That Identifies Potential Defibrillator Lead Fractures

The U.S. Food and Drug Administration announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

FDA Approved Use Of REYATAZ (R) Boosted With Ritonavir, In Combination Therapy, For Previously Untreated HIV-1 Infected Adult Patients

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food & Drug Administration (FDA) approved the use of REYATAZ® (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in previously untreated (treatment-naive) HIV-1 infected patients. REYATAZ boosted with ritonavir (REYATAZ/r) taken once daily with food is recognized by the U.S.

Clinical outsourcing and current trends: How are they affecting business?

The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990â€™s to over US$17 billion in 2007.

Positive Opinion From Committee For Medicinal Products For Human Use (CHMP) For EvicelT Liquid Fibrin Sealant (Human)

OMRIX Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received a positive opinion for EVICELT Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery.

Ecalta (anidulafungin) Recommended For Use In NHS Scotland - Antifungal For Invasive Candidiasis

Pfizer Limited today welcomes the Scottish Medicines Consortium (SMC) advice, which recommends Ecalta® (anidulafungin), a new antifungal medicine for the treatment of invasive candidiasis in NHS Scotland.

NASONEX(R) Now Approved In Japan For The Treatment Of Allergic Rhinitis In Adult Patients

Schering-Plough Corporation (NYSE: SGP) announced that Schering-Plough K.K., the company's country operation in Japan, has received marketing approval for NASONEX(R) (mometasone furoate monohydrate) Nasal Spray 50mcg for the treatment of allergic rhinitis in adult patients.(1) NASONEX is an intranasal steroid that significantly improves nasal allergy symptoms when taken once each day. NASONEX is the first intranasal steroid to be approved in Japan for once-daily administration.

Anestvise Inc will Create New Jobs at New Manufacturing Facility in Eastern Europe

Anestvice Inc. www.anestvice.com , whose customers include major pharmaceutical industry players, specializes in manufacturing of medical devices...

FDA Approves Toviaz, A New Drug To Treat Overactive Bladder

The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.

FDA Proposes Label Requirements For Refused Imported Foods

The U.S. Food and Drug Administration issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk. "This system will make it more difficult for food importers to evade import controls after being denied admission into the United States," said Randall Lutter, Ph.D., deputy commissioner for policy. "It will complement our ongoing efforts to monitor food imports.

Abbott Receives FDA Approval For TRILIPIXT, First And Only Fibrate Indicated For Use In Combination With A Statin For Cholesterol Management

Recently, the U.S. Food and Drug Administration (FDA) approved Abbott's TRILIPIXT (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels.

Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.

ARKRAY USA Receives FDA Clearance On GLUCOCARD(TM) 01 Blood Glucose Monitoring System

ARKRAY USA, Inc. announced 510(k) clearance on GLUCOCARD(TM) 01 Blood Glucose Monitoring System. GLUCOCARD(TM) 01 This new, affordable system requires no coding, displays results in 7 seconds, and requires a tiny 0.3 microliter sample size. GLUCOCARD(TM) 01 is AST approved and has a 360-count test memory with time and date stamp. It also features a large, easy-to-read display for better viewing of test results.

AVI BioPharma Files IND For Clinical Trial Of Marburg Virus Treatment

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, announced the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for a clinical trial to evaluate the Company's antisense drug AVI-6003 for the treatment of Marburg virus infection. AVI plans to conduct the trial as part of its continued collaboration with the US Army Medical Research Institute of Infectious Diseases (USAMRIID).

FDA Reviewing Biomoda Submission For Cancer Screening Study

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 assay for detection of early lung cancer in veterans. The New Mexico state legislature allocated more than $1.

Biopharmaceutical companies focus their attention on outsourcing

In the world of clinical trails it is crucial that the process in which a product goes through the testing and regulatory process be swift at the same time remaining within the budget.

EU Approval For Cymbalta In Generalised Anxiety Disorder

The European Commission has approved the use of Cymbalta (duloxetine) in treating generalised anxiety disorder (GAD), paving the way for the drug to be launched in all 27 member-states of the European Union. The verdict will also allow Cymbalta to be marketed in Iceland, Liechtenstein and Norway. Jointly produced by Eli Lilly (U.S.) and Boehringer Ingelheim (Germany), Cymbalta is already approved for treating GAD in the United States and Mexico.

Wyeth And Progenics Receive Approval From European Commission For Relistor For Opioid-Induced Constipation In Advanced Illness Patients

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), announced that the companies have received marketing approval for RELISTORT (methylnaltrexone bromide) subcutaneous injection from the European Commission.

Massachusetts Department Of Public Health Announces Regulatory Action Against Town Of Hamilton And 24 EMS Workers

The Massachusetts Department of Public Health (DPH) today announced that it has suspended the ambulance license for the town of Hamilton based on an investigation of the training and certifications of a number of the town's emergency medical technicians (EMT). The Department has proposed that the license be revoked for a minimum of one year.

The World Is Getting Better!

According to Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization, the world is getting better, no matter what critics say.

FDA Panel Rejects Black Box Warning On Epilepsy Drugs

A panel of experts that advises the US Food and Drug Administration (FDA) voted last week to reject the Agency's proposal to make manufacturers of 11 epilepsy drugs put the strongest level of warning label on their products (the Black Box warning). The FDA had recommended the Black Box warning because studies showed the drugs had nearly double the risk of suicide compared to placebo, although in absolute terms it was still quite small.

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Gilda's Club Worldwide Spells 'HOPE' To Colon Cancer Patients And Survivors

Cancer advocacy organization Gilda's Club Worldwide offers a message of hope this holiday season to the millions touched by colon cancer with a one-of-a-kind mosaic mural at its New York City headquarters. The 15X6 foot mural was created by more than 165 colon cancer survivors from around the nation as part of a new MOSAIC of Colon Cancer Survivorship program celebrating the strides that have improved colon cancer treatment.

3M Strengthens Respirator Range With New Particulate Respirator With Nuisance Level Organic Vapour And Ozone Relief

Diversified technology company 3M is delighted to announce the launch of its new speciality product, the 9922 FFP2 Particulate Respirator. The latest addition to 3M's comprehensive range of maintenance free respirators provides comfortable protection against fine dusts and oil and water-based mists.

Symptoms Of Major Depression Relieved By St. John's Wort

New research provides support for the use of St. John's wort extracts in treating major depression. A Cochrane Systematic Review backs up previous research that showed the plant extract is effective in treating mild to moderate depressive disorders. "Overall, we found that the St.

Injury to myelinated axons in the CNS often has a devastating outcome in terms of neuronal loss, with accompanying loss of function.

Damage to the nervous system may result from traumatic injury, such as penetrating or blunt trauma, stroke, or neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), diabetic neuropathy or senile dementia...

Deaf Patients Confront Difficulties In Obtaining Basic Health Care

Inadequate healthcare is received by thousands of the United Kingdom's Deaf patients because they are struggling to communicate with their healthcare providers, according to an article released on October 1, 2008 in BMJ. The term Deaf is defined as individuals born Deaf and prefer to communicate in British Sign Language.

Updated Licence For Goserelin (Zoladex 3.6 Mg & Zoladex La 10.8mg) Reflects Survival Benefits In All Stages Of Prostate Cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated licence to goserelin 3.6mg and goserelin LA 10.8mg [i] to reflect survival benefits in all three stages of prostate cancer (localised, locally advanced and advanced also called metastatic).

AZILECT(R) Shown To Be A Selective MAO-B Inhibitor - Teva To Work With FDA To Modify The Azilect(R) Label

What Clinical Research Is All About

Jazz Pharmaceuticals And UCB Announce Positive Phase III Results For Sodium Oxybate In Fibromyalgia

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) and UCB (Euronext Brussels: UCB) announced today positive preliminary top-line results from the first of two Phase III clinical trials of sodium oxybate (JZP-6) for the treatment of fibromyalgia. The randomized, double-blind, placebo-controlled study achieved its key endpoints, demonstrating that sodium oxybate significantly decreased pain and fatigue, and improved daily function in patients with fibromyalgia.

National Consistency In Gov't Reimbursement For Breast Prostheses, Australia

The Australian Medical Association welcomed the long-awaited Federal Government rollout of a program that will help cancer survivors with the cost of new and replacement breast prostheses. AMA President, Dr Rosanna Capolingua, said the AMA had been concerned for patients and their ability to afford breast prostheses. "Up until now, women with breast cancer in different States of Australia received differing levels of support for breast prostheses.

First Human Use Of New Device To Make Arrhythmia Treatment Safer

On June 16, 2008, Barbara Ganschow of Palatine, IL, became the first person in the world to be successfully treated with a new device designed to make it safer and easier for heart specialists to create a hole in the cardiac atrial septum. The hole, created by the NRGTM Transseptal Needle, allows cardiac catheters to cross from the right side of the heart to the left side.

Kriger Graduates Have Come To Realize Their Potential Within The Industry And Have Gone On To Successful Careers.

Kriger www.krigerinternational.com has maintained it's status within the industry because these training courses lead to the creation of highly trained individuals, due to the rigorous tasks that each student must perform in the projects.

Landmark 15-Year Study Of UCLA Kidney Cancer Patients Shows Aggressive, Personalized Therapy Improves Survival

A study of nearly 1,500 patients treated for kidney cancer at UCLA in the last 15 years shows that an aggressive, tailored treatment approach results in better survival rates and uncovered subsets of kidney cancer that behave differently and need to be treated accordingly.

Phase 3 Data Demonstrate Efficacy And Tolerability Of Paliperidone Palmitate, An Investigational Long Acting Therapy For Schizophrenia

Paliperidone palmitate, an investigational long-acting therapy (LAT) demonstrated statistically significant symptom control compared with placebo according to the results of a 13-week study presented today (1). Statistical significance was evidenced at all doses tested (25, 100, and 150 mg equivalent [eq.a]), when given every 4 weeks with a 150 mg eq. initiation dose. A separate 53-week non-inferiority trial(b) evaluating paliperidone palmitate using only a 50 mg eq.

Orexigen(R) Therapeutics Presents Data On Its Proprietary Formulation Of Naltrexone Sustained Release (SR) Used In Contrave(R)

Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, presented data showing the investigational drug, Contrave(R) (naltrexone SR / bupropion SR), successfully achieved key objectives (lowered naltrexone Cmax, increased Tmax, comparable AUC) in two Phase 1 clinical trials.

Esploron is one of the innovative companies within the CRO industry.

Esploron www.esploron.com is one of the innovative companies within the CRO industry.

ACTEMRA (R) (tocilizumab) Significantly Reduced Signs And Symptoms Of Rheumatoid Arthritis In Patients Who Failed Prior Treatments

Data from two Phase III studies showed that patients who suffer from the debilitating and painful effects of rheumatoid arthritis (RA) achieved significant improvements in signs and symptoms when treated with ACTEMRA(R) (tocilizumab) alone or in combination with methotrexate compared with methotrexate alone.

Monthly Replacement Contact Lens Wearers Report A Decrease In Wearing Comfort Over The Course Of A Month, Research Shows

Monthly replacement contact lens wearers notice a decline in lens performance in weeks three and four of wear, a survey reveals. Findings from the research among monthly lens wearers in France, in which 20 different brands of lenses were represented, show a decrease in wearing comfort over the course of a month, with no significant differences between wearers of hydrogel and silicone hydrogel monthly replacement lenses.

Visipaque Linked To Lower Incidence Of Contrast-Induced Nephropathy And Cardiovascular Events In Chronic Kidney Disease Patients Compared To Iopromide

A first-ever 208-person study comparing the renal safety, occurrence of cardiovascular adverse events and diagnostic image quality of GE Healthcare's isosmolar contrast media (CM) iodixanol (Visipaque) and the low-osmolar CM iopromide in select patients concluded iodixanol is associated with lower incidence of contrast-induced neuropathy (CIN) and cardiovascular events (CV) than iopromide, when used in patients with chronic kidney disease.

Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).

Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.