Latest News About Regulatory Affairs!

UT Southwestern Digestive Specialists Freeze Out Esophagus Cancer With New Therapy

UT Southwestern Medical Center gastroenterologists are using a new method to freeze damaged cells in the esophagus, preventing them from turning cancerous. The Food and Drug Administration-approved cryoablation therapy helps Barrett's esophagus patients with dysplasia, a condition in which normal cells are transformed into potentially cancerous ones.

FDA And PATH Malaria Vaccine Initiative Announce Research Collaboration

The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. "This collaboration with the PATH-MVI supports the overall mission of the FDA and specifically the Agency's work under our Critical Path Initiative," said Jesse L. Goodman, M.D., M.P.H.

Safety Of Imported Foods Addressed In New Publication

As the proportion of imported foods in the food supply continues to increase, Americans are putting themselves at a potentially greater risk for foodborne disease as some countries may not have the same sanitary standards as the U.S. Imported Foods: Microbiological Issues and Challenges, the latest book in the ASM Press series Emerging Issues in Food Safety, thoroughly explains one of the greatest weaknesses in the U.S. food safety system and outlines steps necessary to remedy it.

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...

Board Certification Turns 75, USA - American Board Of Medical Specialties

American Board of Medical Specialties (ABMS), the organization that oversees the board certification process of specialty physicians in the United States, is observing 75 years of public service by reflecting on the significance of specialty boards and the board certification system in public medicine and renewing its public commitment to provide meaningful information about a physician's board certification. The organization was officially formed Sept. 20, 1933.

FDA Approves Energex Systems, Inc. Non-Drug Therapy For HIV Research

Energex Systems, Inc. announced that it has been granted approval from the Federal Food and Drug Administration (FDA) to utilize its experimental HemoModulationT therapy in a clinical trial of HIV infected patients. The purpose of the study will be to demonstrate safety and monitor viral load changes in patients who are not yet eligible for antiviral drug therapy. HIV is a retrovirus that attacks the immune system, destroying or impairing its function.

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.

Understanding the Importance of ICH GCP is Vital to the Continued Safety of Clinical Patients.

Several Kriger www.krigerinternational.com course sessions are dedicated to understanding concepts and principles that have helped mold the industry into what it is today. This gives each student the opportunity to understand how the industry is progressing...

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.

Insomnia - EMEA Issues Positive Opinion For LUNIVIA(R) (Eszopiclone) Marketing Authorization Application (MAA) In Europe

Sepracor Inc. (Nasdaq: SEPR) today announced that the EMEA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending to grant a marketing authorization for LUNIVIA® brand eszopiclone in the European Union (EU) for the treatment of insomnia. The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short-term. LUNIVIA is marketed in the U.S.

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.

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.

Marketing Authorization Application For Satraplatin Is To Be Withdrawn

GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) reported that the Company has been informed by its partner for satraplatin in Europe that they plan to withdraw the Marketing Authorization Application (MAA) for satraplatin plus prednisone for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.

Supplemental New Drug Application For Risperdal® Consta® Submitted To The FDA For The Treatment Of Bipolar Disorder

Alkermes, Inc. (NASDAQ: ALKS) today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a supplemental New Drug Application (sNDA) for RISPERDAL® CONSTA® [(risperidone) Long-Acting Injection] to the U.S. Food and Drug Administration (FDA) for approval as monotherapy in the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adults.

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.

Kriger Courses Are Indispensable To Break Into The Biopharmaceutical And Clinical Research Industry.

From what many of our students have said, Kriger www.kriger.com and their professional development courses are not only inspiring but also indispensable when trying to start a career in the biopharmaceutical and clinical research industry.

FDA Approves Rapaflo For The Treatment Of Symptoms Due To An Enlarged Prostate Gland

The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. BPH is a male disease wherein the prostate gland - located between the bladder, which stores urine, and the urethra, the tube through which urine exits the body - enlarges in men as they age. By age 50, roughly 50 percent of all men suffer from BPH.

FDA Posts Names Of Prescription Drugs Being Investigated For Potential Safety Problems

FDA officials on Friday said the agency will begin publishing quarterly a list of drugs being investigated for potential safety risks, the Washington Post reports. The

World's First Blood-Based Diagnostic Test For Human Appendicitis - FDA 510(k) Clinical Trial Progress For AppyScore

AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported the enrollment level in the ongoing FDA 510(k) clinical trial for AppyScore(TM), the world's first blood-based diagnostic test for human appendicitis, has reached approximately 70%.

It is recommended that sponsor companies should first check what budget they can allocate, and then seek Clinqua Inc. expertise in achieving their goal.

It is an undesirable reality, but the development of pharmaceutical drugs is a costly undertaking. Yet, these costs are necessitated by the substantial investment of both time and resources of the companies in question. It stands to reason that if a company is willing to invest millions of dollars that they would seek individuals and companies that had the professionals, resources, and capacity to minimize overhead costs and the time needed to bring a drug to the market.

Merck Serono Submits New License Application For Erbitux In 1st-Line Non-Small Cell Lung Cancer In Europe

Merck Serono announced that it has submitted an application to the European Medicines Agency (EMEA) to license Erbitux (cetuximab) for the 1st-line treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small cell lung cancer (NSCLC). The submission is supported by data from the Phase III FLEXa study presented this year at a plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting.

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.

New FDA Produce Irradiation Rule

The Food and Drug Administration's new (Aug. 22) regulation that will allow irradiation pasteurization to be used on fresh spinach and iceberg lettuce to kill illness-causing bacteria is a step that two Iowa State University professors have long advocated. Dennis Olson is a professor of animal science and directs Iowa State's Linear Accelerator Facility, one of only two commercial-sized irradiation facilities for food research and demonstration on a U.S. university campus.

US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril Derivatives

Cereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex.

American Veterinary Medical Association Addresses Livestock Health Issues Before U.S. Congress

The American Veterinary Medical Association (AVMA) testified today before the U.S. Congress on advancements to animal health in the livestock industry, describing for lawmakers progress made improving public health and reaffirming the importance of treating food animals with antibiotic medicines. Addressing the U.S. House of Representatives Committee on Agriculture's Subcommittee on Livestock, Dairy, and Poultry, Dr.

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.

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.

Kriger Courses Are Indispensable To Break Into The Biopharmaceutical And Clinical Research Industry.

Vectibix(R) Now Available For The Treatment Of Advanced Colorectal Cancer In Belgium

Amgen Belgium announces the availability of Vectibix® (panitumumab), the first fully human anti-EGFR monoclonal antibody indicated as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) with non-mutated (wild-type) KRASgene after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy protocols.

FDA Approves ACIPHEX(R) (rabeprazole Sodium) 20 Mg For Short-Term Treatment Of GERD In Adolescents

Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above. Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients.

Intercell Making Strides Towards Imminent Approval Of Its Japanese Encephalitis Vaccine In The United States

Following the positive feedback from the FDA, Intercell announced today an update on the regulatory approval processes for its Japanese Encephalitis vaccine in the United States, Europe and Australia. In the US, Intercell has concluded all submissions requested by the FDA towards licensure. The remaining final formal alignment steps on Product Insert leaflet and Product Release protocol have been initiated.

Kriger Research Group International joins TrialStat's CROFIRST Program

Worldwide Contract Research Organization (CRO) Deploys ClinicalAnalytics 4.0 for its Clinical Trials

Committee On The Safety Of Devices (CSD): New Members Required - Application Deadline Reminder, MHRA, UK

The Committee on the Safety of Devices is looking for candidates to replace The Chair, one lay member and 12 specialist members with current experience in one of the following fields: -- Accident and Emergency Medicine -- Cardiology -- Clinical Chemistry -- Dentistry

FDA Approves Johnson & Johnson's Prezista For HIV-Positive People Who Have Never Taken Antiretrovirals

FDA on Tuesday approved Johnson & Johnson's protease inhibitor Prezista for use by people who have never taken antiretroviral drugs in the past, the Wall Street Journal reports. FDA in 2006 approved Prezista for HIV-positive people who had developed resistance to other drugs.

EU Moves Must Not Put GPs At Catch-22 Risk, Warns Medical And Dental Defence Union Of Scotland

EU moves to clarify citizens' rights to cross-border healthcare could foist on GPs the responsibility of acting as "gatekeepers" for the NHS, warns the Medical and Dental Defence Union of Scotland (MDDUS) today (Tuesday, 4 November 2008). And as such doctors could face a GMC hearing or a discrimination tribunal, caught in a Catch-22 that damns them if they act and damns them if they don't, says the MDDUS.

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...

The European Medicines Agency Recommends Suspension Of The Marketingauthorisation Of Acomplia

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU).

FDA Clears MBL Bullous Pemphigoid ELISA Test

MBL International Corporation of Woburn, Massachusetts is announcing that the United States Food and Drug Administration, FDA, has cleared the BP180 and BP230 ELISA Kits for the detection of Bullous Pemphigoid (BP), the new kits have been CE marked as well. The new kits are seen as an advance in diagnosing Bullous Pemphigoid.

Historic Appeals Case Against The Tobacco Industry Positions Court To Decide On Key Tobacco Control Issues

Statement of the American Lung Association: Today, The U.S. Department of Justice and Public Health Intervenors, including the American Lung Association, presented oral arguments before the United States Court of Appeals in a landmark case against the tobacco industry.

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.

Sanofi-Aventis Pharma S.A. Withdraws Its Application For An Extension Ofindication For Taxotere And Docetaxel Winthrop (docetaxel)

The European Medicines Agency (EMEA) has been formally notified by Sanofi-Aventis Pharma S.A. of its decision to withdraw its application for an extension of indication for the centrally authorised medicines Taxotere (docetaxel) 20 mg/0.5 ml and 80 mg/2 ml, concentrate and solvent for solution for infusion and Docetaxel Winthrop (docetaxel) 20 mg/0.5 ml and 80 mg/2 ml, concentrate and solvent for solution for infusion.

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).

UCB Receives Not-Approvable Letter From FDA For Lacosamide For Diabetic Neuropathic Pain

UCB announced that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults. The company will seek clarification from the FDA of its position and of the additional information required to obtain final marketing approval.

Pharmalef Inc. is starting collaboration in development of new oral delivery platform

Pharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.

Cepheid Molecular Diagnostic Test For Positive Blood Culture Bottles Categorized 'Moderate Complexity' By FDA

Cepheid (Nasdaq: CPHD) announced the U.S. Food & Drug Administration (FDA) categorized Cepheid's Xpert(TM) MRSA/SA Blood Culture (BC) test as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in positive patient blood culture bottles.

Alcohol Dependence Drug Can Cause Adverse Reactions Warned FDA

The US Food and Drug Administration (FDA) issued an alert to healthcare professionals on Tuesday advising them of the risk of adverse injection site reactions in patients given injections of Vivitrol (generic name naltrexone), a drug that is used to treat alcohol dependence. Vivitrol ( naltrexone) is marketed in the US by Cephalon Inc.

Imported Baby Formula Flying Off Shelves As China Fails To Control Tainted Milk Products

Imported baby formula is flying off the shelves in China, as the Chinese government fails to convince consumers that it is able to stop corrupt manufacturers from adding toxic chemicals to milk products. A report by the BBC said that food inspectors in China are not able to control the companies that are adding toxic substances such as melamine to milk powder that is fed to children.

What the Title of Home-based Clinical Research Associate Really Means

The title of Clinical Research Associate is deceiving to some degree. Many people think of â€œassociateâ€ as a secondary low paying job. â€œClinical Monitorâ€ is a title that better describes what CRA job entails. A clinical research associate does not, in fact, assist anyone; the associate coordinates the smooth progress of a clinical trial.

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.

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.

Statement On FDA's Approval Of XENAZINE(R) For The Treatment Of Chorea Associated With Huntington's Disease

The Hereditary Disease Foundation (HDF) is extremely pleased the U.S. Food and Drug Administration has approved Xenazine, or tetrabenazine, for the treatment of chorea associated with Huntington's disease. "Chorea is a major cause of disability and death in patients with Huntington's disease.

Anestvice Pressure Controller (APC) â€“ device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery

Anestvice ( www.anestvice.com )Pressure Controller (APC) â€“ device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery...

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.

FDA To Post Quarterly Report Of Potential Safety Issues

The U.S. Food and Drug Administration announced that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007.

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.

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 Abbott's XIENCE(TM) V Drug Eluting Stent

Abbott announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's TAXUS(R) paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. XIENCE V will be launched in the United States immediately.

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.

FDA Warns Consumers About Potential Problems At Two Baltimore Pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

ClinQua Inc: Regulatory Agencies Do Not Require Clinical Trials To Be Expensive!

Mr. David Mills former ClinQua Clinical Trials Inc. www.clinqua.com executive argues that the inevitable burden of clinical investigation is cost, and unfortunately, the weight of that burden falls onto consumers...

Abbott Begins Post-Approval Study Of XIENCE VT Drug Eluting Stent

Abbott announced the start of the XIENCE VT USA post-approval study, with six hospital centers already recruiting and enrolling patients just one week after the U.S. Food and Drug Administration approved the XIENCE VT Everolimus Eluting Coronary Stent System. The XIENCE V USA study will evaluate the safety and effectiveness of the XIENCE V drug eluting stent in a real-world clinical setting out to five years. Jack Jones, M.D.

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.

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.

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...

PPD Confirms Takeda's NDA Submission Of Alogliptin And ACTOS(R) To U.S. FDA - Single Tablet For Diabetes Type 2

PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited has submitted a new drug application to the U.S. Food and Drug Administration for marketing approval of alogliptin (SYR-322) and ACTOS® (pioglitazone HCl) in a single tablet for the treatment of type 2 diabetes. "We are very pleased with Takeda's progression of the development of alogliptin/ACTOS," said Fred Eshelman, PPD's chief executive officer.

European Commission Announces Marketing Authorisation For 50mg Once Weekly Enbrel(R) For Patients With Moderate-To-Severe Psoriasis

The European Commission announced a new 50mg Enbrel® (etanercept) once weekly dosage regimen as an alternative to the currently approved 25mg Enbrel® twice weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis. Based on the outcome of the extensive European 318 study in adult patients with moderate-to-severe plaque psoriasis, the European Commission issued the marketing authorisation for the European Union for a once weekly 50mg Enbrel® dosing.

Viev all historical articles...

Joint Commission Accreditation: Lab Decisions Will No Longer Affect Hospital Decisions

Beginning January 1, 2009, under new Joint Commission policy, laboratory accreditation decisions will no longer immediately impact hospital accreditation decisions. This policy establishes comparability in the way that a laboratory with an adverse accreditation decision rendered by The Joint Commission or one of its cooperative partners, College of American Pathologists (CAP) or COLA, impacts the hospital or other organization with which the laboratory is affiliated.

Possibilities For HHS Secretary, FDA Commissioner In Obama Administration Discussed

Democratic congressional staffers and others have begun "floating names for top health posts" in the administration of President-elect Barack Obama that include several possibilities for HHS secretary, the Wall Street Journal's "

Nation's Economic Downturn Threatens Continuity Of Care For Chronic Conditions, USA

DMAA: The Care Continuum Alliance, responding to reports that many Americans are forgoing basic medical care in the economic downturn, today called for renewed vigilance in the fight against chronic disease and support for care management "While some forms of belt-tightening make sense

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

American Veterinary Medical Association Addresses Livestock Health Issues Before U.S. Congress

DHSS Proposes New Rules At N.J.A.C. 8:57-3 Governing The New Jersey Immunization Information System

The Communicable Disease Service of the Division of Epidemiology, Environmental and Occupational Health in the Public Health Services Branch of the Department of Health and Senior Services (Department) is proposing new rules at N.J.A.C. 8:57-3, governing the New Jersey Immunization Information System (NJIIS). The notice of proposal appears in the October 20, 2008 issue of the New Jersey Register. On April 21, 2008 at 40 N.J.R.

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

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.

New Drug Application For Inhaled Treprostinil Submitted To The U.S. Food And Drug Administration

United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary, Lung Rx, Inc., announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of an inhaled formulation of treprostinil (ITRE) for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disease. The submission starts a 60-day period during which the FDA will examine the application for completeness.

Mundipharma Submits New Analgesic Targin (Prolonged Release Oxycodone / Naloxone Combination) For European Approval

Mundipharma announced that Targin, an oral prolonged-release oxycodone / naloxone combination tablet, has been submitted for regulatory approval in Europe. Targin is a combination of a strong opioid receptor agonist, oxycodone, and a locally acting opioid receptor antagonist, naloxone.

Marketing Authorization Application For Satraplatin Is To Be Withdrawn

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

Arana Files IND For Lead Anti-Inflammatory Product ART621 In Rheumatoid Arthritis (RA) Indication

Biotechnology company Arana Therapeutics Limited (ASX: AAH) announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug Administration) for the anti-inflammatory product ART621 in a rheumatoid arthritis (RA) indication. The IND includes a Phase II dose ranging study of ART621/221 in RA which is planned to be an international multi-centred trial of approximately 200 patients.

Coapt Systems Launches FDA Cleared Novielle Voice (TM) For Restoration Of Voice Loss

Coapt Systems Inc. announced the launch of its Novielle Voice family of injectable fillers at the 112th annual meeting of the American Academy of Otolaryngology -- Head and Neck Surgery (AAO-HNS) in Chicago, IL, September 21-24, 2008. The U.S. Food and Drug Administration (FDA) cleared Novielle Voice Gel and Novielle Voice GelPlus earlier this year for restoration of voice loss.

Dynavax And Merck Provide Update On U.S. FDA Clinical Hold On Investigational Vaccine HEPLISAVT

Dynavax Technologies Corporation (NASDAQ:DVAX) and Merck & Co., Inc. have received communication from the U.S. Food and Drug Administration (FDA) regarding the two companies' response to the agency's request for safety information relating to the clinical hold on the two Investigational New Drug (IND) Applications for HEPLISAVTM, an investigational hepatitis B virus (HBV) vaccine.

ClinQua Inc. is one of CRO's focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits.

ClinQua Inc. www.clinqua.com is one of CRO's (Contract Research Organizations), who specialize in evaluating the demands of the trial and eliminating redundant protocols and focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits.

FDA Warns Bayer About Two Illegal Aspirins

The US Food and Drug Administration (FDA) has written warning letters to drug company Bayer HealthCare about two over the counter (OTC) aspirins that contain supplements and claim to be effective not only for pain relief but against heart disease, and this constitutes a use for which the drugs have not been given approval and therefore makes them illegal said the agency in a statement on Tuesday.

FDA Approves Bausch & Lomb AkreosT Advanced Optics Aspheric Lens

Bausch & Lomb announced it has received U.S. Food and Drug Administration (FDA) approval to market the AkreosT Advanced Optics Aspheric Lens (model AO60) in the United States. The Akreos AO Lens is a single-piece, foldable acrylic intraocular lens with a unique four-haptic design and aspheric optics designed to be aberration-free.

Cancer Drug Vidaza(R) Receives Positive Opinion From European Regulatory Authority For Treatment Of MDS And AML

The positive opinion includes important survival data from the AZA-001 trial in higher-risk MDS patients. The CHMP, which reviews applications for all 27 Member States in the European Union (EU) as well as Norway and Iceland, has recommended approval for azacitidine. The CHMP's positive opinion will be forwarded to the European Commission, which generally follows the recommendation of the CHMP and typically issues final marketing approval within two to three months.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury. It significant decreases in the degree of edema developed after injury was found following treatment postponed one hour after traumatic injury..

Bayer Agrees To Stop Running Ads For Oral Contraceptive YAZ That FDA Says Are 'Misleading'

Earlier this week, the pharmaceutical company Bayer agreed to stop airing commercials for the oral contraceptive YAZ in response to an Oct. 3 warning letter from FDA telling the company that the advertisements overstate the benefits of the drug. According to the FDA letter, the commercials "broaden the drug's indication, overstate the efficacy of YAZ and minimize serious risks associated with the use of the drug.

FDA Approves 2008-2009 Flu Vaccines

The U.S. Food and Drug Administration (FDA) announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc.

Cadbury Recalls Chocolate Products Made In China

Various media sources are reporting that Cadbury, the world's largest confectionery manufacturer, is recalling 11 Chinese made products distributed in the Far East, including Dairy Milk bars, after finding they contained traces of melamine, the toxin that is suspected to have killed four babies and made over 54,000 others ill with kidney related problems after they ingested contaminated milk products made in China.