Latest News About Regulatory Affairs!

Antiangiogenic And Anti-Inflammatory Drugs: Are They Safe?

Since Rofecoxib (Vioxx) was withdrawn from the worldwide market based on the safety findings of the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, the uncertainty around the cardiovascular safety of NSAIDs and COX-2 inhibitors remains and leaves practitioners with difficult management decisions for the hundreds of millions of patients worldwide who continue to require pain-relieving therapy to maintain an acceptable quality of life.

The Scottish Medicines Consortium (SMC) Approves Avamys (fluticasone Furoate) For Allergic Rhinitis

The Scottish Medicines Consortium (SMC) has today accepted Avamys for use within NHS Scotland. Avamys is a new intranasal steroid (INS) manufactured by GlaxoSmithKline (GSK), for the treatment of the symptoms of allergic rhinitis (AR).1 Approximately 16 million people in the UK, which equates to over a quarter of the population, suffers from allergic rhinitis.

FDA Grants Orphan Drug Designation To Oncophage For The Treatment Of Glioma

Antigenics Inc. (NASDAQ: AGEN) announced that Oncophage® (vitespen) has been granted orphan drug status for the treatment of glioma (brain cancer) by the US Food and Drug Administration (FDA). In March, the European Medicines Agency (EMEA) granted a similar designation for Oncophage. "Glioma is such an aggressive and challenging cancer that when patients are diagnosed with recurrence of this life threatening disease, they rarely live beyond six months," said Andrew T.

Kriger Research Group International joins TrialStat's CROFIRST Program

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

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.

Guided Therapeutics, Inc. Reports Preliminary Findings From FDA Pivotal Clinical Trial

Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced that its LightTouchT non-invasive cervical cancer detection technology properly identified cervical disease missed by Pap tests and conventional pathology in a multi-site Food and Drug Administration (FDA) pivotal clinical trial. Based on the outcome of the study, GT plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch.

Patients enrolment is a greatest challenge for the clinical research industry in the USA, Canada and European Union.

Patients enrolment is a greatest challenge for the clinical research industry in the USA, Canada and European Union.
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Xarelto(R) Approved In Canada - Venous Blood Clot Prevention After Elective Total Knee And Hip Replacement Surgery

Health Canada has granted Bayer HealthCare marketing authorization for the anticoagulant Xarelto® (rivaroxaban), taken as one tablet, once-daily, for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery. This decision marks the first approval for Xarelto worldwide. Bayer will start marketing the product immediately.

CTI To Meet With The FDA To Discuss Filing Of A Supplemental Biologics License Application For Zevalin(R)

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that the Company has scheduled a meeting with the U.S. Food and Drug Administration (FDA) in September to discuss the possibility of filing a supplemental Biologics License Application (sBLA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma.

FDA: More Than $1.5 Million Of Adulterated Food, Food Ingredients Seized

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized more than $1.5 million worth of food products, including herbs and botanicals, stored under filthy conditions at the American Mercantile Corporation of Memphis, Tenn. During an inspection of American Mercantile in March, FDA investigators discovered evidence of extensive rodent and insect infestation throughout the company's warehouse. The company failed to correct these problems.

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...
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Government Of Canada Takes Action On An Additional Four Substances Assessed Under Canada's World-Leading Chemicals Management Plan

The Honourable Leona Aglukkaq, Minister of Health, and Canada's Environment Minister, the Honourable Jim Prentice, today announced the release of the final screening assessment reports and proposed risk management approaches for 19 substances included in Batch 3 on the Government's chemicals management website. "This is an important step towards further protecting the health of Canadians and our environment," said Minister Aglukkaq.

HHS Extends Deadline For Bidders In Competitive Range For Recombinant Anthrax Vaccine Contract To Submit Development Plan To FDA For Review

Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Department of Health and Human Services (HHS) issued an additional amendment to its request for proposal for an Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic National Stockpile.

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.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.
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Hayashi Legislation Prompts Court Ruling To Expand Access To Prenatal Care - California

The San Francisco Superior Court has struck down a state law requiring that low-income working women must have resided in California for at least six months before they can be eligible to receive prenatal and other medical care services through California's Access for Infants and Mothers (AIM) insurance program.

FDA Tells Cheerios Cereal Makers Their Health Claims Contain "Serious Violations"

The US Food and Drug Administration has written a warning letter to General Mills, the makers of the popular breakfast cereal Cheerios, explaining that they have reviewed the labelling of the product and found it contains "serious violations" of federal regulations.

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.

Why Clinical Research Companies Cannot Hire CRA’s Without Experience?

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and clinical research organization, there are three main reasons that actual experience is essential:
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Hyperion Therapeutics Completes Phase 2 Data Analysis And Schedules End Of Phase 2 Meeting With FDA For HPN-100

Hyperion Therapeutics, Inc. reported completion of data analysis for its Phase 2 clinical trial designed to evaluate the safety, tolerability and ammonia scavenging effects of HPN-100 versus BUPHENYL(R) (sodium phenylbutyrate), the current standard of care in patients with urea cycle disorders. Data from the trial will be presented at an upcoming medical conference.

Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date.

SEROQUEL XRT And SEROQUEL(R) Approved In Europe For New Indications For The Treatment Of Bipolar Disorder

AstraZeneca today announced that the once-daily formulation SEROQUEL XRT (quetiapine fumarate extended release tablets) and SEROQUEL® (quetiapine fumarate) have been approved via the Mutual Recognition Procedure for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for treatment of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has been approved for treatment of moderate to severe manic episodes in bipolar disorder.

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.
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Neuralstem's ALS Trial On Clinical Hold

Neuralstem, Inc. (NYSE Alternext US: CUR) announced its spinal cord stem cell trial to treat ALS is on clinical hold and that the Federal Drug Administration (FDA) has provided the Company with specific comments, questions and recommendations for modifications to its protocol. "The FDA has presented us with their review of our entire Investigational New Drug (IND) application," said Richard Garr, Neuralstem's President & CEO.

Lower Age For Plan B Access Is 'Break From Ideologically Driven Policies,' NYT Editorial Says

FDA's decision Wednesday to allow nonprescription access to the emergency contraceptive Plan B for individuals ages 17 and older was a "further break from the Bush administration's ideologically d

U.S. Grown Jalapeno And Serrano Peppers Not Connected To Salmonella Saintpaul Outbreak

The U.S. Food and Drug Administration is advising consumers that jalapeno and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalapeno peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.

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
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Meridian Bioscience Receives FDA Clearance For New Rapid Campylobacter Test

Meridian Bioscience, Inc. (NASDAQ: VIVO) announced that it has received FDA clearance from the U.S. Food and Drug Administration (FDA) for a new rapid test for Campylobacter, ImmunoCard STAT!® CAMPY. This new test provides fast and accurate detection of Campylobacter bacteria, one of the most common causes of diarrheal illness and the most common bacterial cause of foodborne illness in the United States. Approximately 20 million stool culture tests are conducted each year in the U.S.

Centocor, Inc. Submits Application To FDA Requesting Approval Of Golimumab For The Treatment Of Rheumatoid Arthritis

Centocor, Inc. announced that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Somaxon Provides Update On New Drug Application For Silenor(R) (doxepin) For The Treatment Of Insomnia

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia. Somaxon held a meeting with the Division of Neurology Products of the U.

The Birth of the Profession of Clinical Research Associate

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

NMT Medical Receives PMA Approval For STARFlex(R) As A Ventricular Septal Defect Repair Implant

NMT Medical, Inc. (NASDAQ: NMTI), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced that it received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) enabling commercial sale of the Company's

Kensey Nash Announces IDE Submission For Cartilage Repair Device

Kensey Nash Corporation (Nasdaq: KNSY) announced that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to study the use of the Company's unique biomaterials technology for treating articular cartilage defects of the knee. The clinical trial will utilize the Company's Cartilage Repair Device, which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions.

Pharmalef Developments plays a vital role in proper documenting the drug development process.

New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market.
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European Medicines Agency Makes Recommendations For Safer Use Of Ritalin and Other Methylphenidate-containing Medicines In The EU

The European Medicines Agency (EMEA) has concluded that methylphenidate-containing medicines remain suitable for the treatment of children aged six years or older and adolescents with attention deficit/hyperactivity disorder (ADHD). It has also recommended that the product information be made consistent across the European Union (EU) so that all patients, carers and prescribers have the same information for safer and more appropriate use of these medicines.

Kaiser Daily Health Policy Report Feature Highlights Recent Blog Entries

"Blog Watch" offers readers a roundup of health policy-related blog posts.The American Prospect's Ezra Klein looks at different options Senate Democrats might attempt for budget reconciliation.

Servier Commited To Working With Nice To Ensure Timely Re-Evaluation Of Osteoporosis Guidance, UK

Following the successful Judicial Review instigated by Servier Laboratories Limited, the licence holder of Protelos® (strontium ranelate), against the National Institute for Health and Clinical Excellence (NICE) guidance for the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women,1,2 Mr Justice Holman today set out a clear process for the re-evaluation of the guidance.

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.
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Revlimid(R) Receives Preliminary Positive Recommendation From NICE For Use In The NHS In England And Wales

Celgene International SĂ rl (Nasdaq:CELG) today announced that the company has received a preliminary positive recommendation from NICE for the use of REVLIMID in the NHS in England and Wales. The recommendation specifies the use of REVLIMID, in combination with dexamethasone, as an option for the treatment of patients with multiple myeloma who have received two or more prior therapies.

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.

FDA Approves Expanded Label For CANCIDAS(R) As The 1st And Only Echinocandin Therapy For Pediatric Patients With Indicated Fungal Infections

Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for CANCIDAS®, which makes it the first and only echinocandin therapy approved in the United States for the treatment of pediatric patients aged 3 months to 17 years with indicated fungal infections.

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.
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Obama Nominates Former NYC Health Chief Hamburg For FDA Head, Baltimore Health Chief As Deputy

President Obama on Saturday announced his selection of former New York City Health Commissioner Margaret Hamburg as his nominee for FDA commissioner and Baltimore health commissioner Joshua Sharfstein as Hamburg's deputy, the AP/Arizona Daily Star reports (AP/Arizona Daily Star, 3/15). According to the

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.

U.S FDA Grants Pralatrexate Orphan Drug Designation For The Treatment Of Patients With Follicular Lymphoma

Allos Therapeutics, Inc. (Nasdaq:ALTH), a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the Company's novel antifolate, pralatrexate (PDX), for the treatment of patients with follicular lymphoma.

CROs in the new millennium

The Clinical Research Organization industry has reached a new level of development in clinical trials. There are now more than twelve hundred CROs with the greatest number existing in Europe, followed by North America and Asia.
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European Medicines Agency Proposes Pilot Program To Rationalize International GMP Inspection Activities

As part of its collaboration with international medicines regulators on goods manufacturing practice (GMP) inspections, the European Medicines Agency (EMEA) has coordinated a group of participating regulators (EU Member States, the US Food and Drug Agency (FDA) and the Australian Therapeutic Goods Administration) and has published a proposal for coordinating inspection plans between them to avoid duplicating inspection work.

European CHMP Adopts Positive Opinion For Aztreonam Lysine

Gilead Sciences, Inc.

MDRNA, Inc. Receives Full FDA Approval Of Generic Calcitonin-Salmon Nasal Spray For Osteoporosis

MDRNA, Inc. (NASDAQ: MRNA) announced that it has obtained full U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis and that Par Pharmaceutical Companies, Inc. (NYSE: PAR) has launched the product.

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.
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FDA: Insulin Pens And Insulin Cartridges Must Not Be Shared

The U.S. Food and Drug Administration issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses. Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge.

FDA To Strengthen Warnings On Diabetes Drug After 2 More Deaths

Futher to an alert it issued in October 2007, the US Food and Drug Administration (FDA) is planning to strengthen the warnings on diabetes drug Byetta (exenatide) after receiving reports of another 6 patients having to be admitted to hospital, two of whom died, because they got hemorrhagic or necrotizing pancreatitis after taking the drug. The four surviving patients are now recovering, said the FDA.

Product For Use In Pediatric Cardiac Surgery: Hebrew University Professor's Work Leads To FDA Approval

A material developed at the Hebrew University of Jerusalem that is designed to prevent adhesions (scar tissue) following surgery has led to approval by the U.S. Food and Drug Administration (FDA) of a product for use in pediatric cardiac surgery patients. The product is the result of Prof. Daniel Cohn's invention of novel, tailor-made, biodegradable polymers for the prevention of post-surgical adhesions. SyntheMed Inc. of Iselin, N.J. in the U.S.

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.
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Untangling DNA Regulation - MIT Biologists Theorize Role For DNA Packaging In Stem Cell Development

MIT biologists have discovered that the organization of DNA's packing material plays a critical role in directing stem cells to become different types of adult cells. The work, to be published in the journal Cell on Nov. 14, could also shed light on the possible role of DNA packaging in cancer development.

FDA Warns Public Of Extortion Scam By FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered.

FDA Scientists Request Investigation Into Agency Approval Of Breast Imaging Device

Scientists at FDA have requested that Congress and President-elect Obama investigate their allegations that an FDA official approved the sale of a breast cancer imaging device over the objections of the front-line scientists after receiving a phone call from a Connecticut congressman, according to the New York Times.

Understanding Your Liability and Confidentiality in Clinical Trials

Clinproxy, www.clinproxy.com fully understands the issues, laws risks and best practices relating to disclosures of confidential information about clinical trials.
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RISPERDAL(R) CONSTA(R) Approved In Japan

Alkermes, Inc. (NASDAQ: ALKS) today announced that Janssen Pharmaceutica K.K. received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to market RISPERDAL® CONSTA® [(risperidone) long-acting injection] for the treatment of schizophrenia. RISPERDAL CONSTA is the first long-acting atypical antipsychotic to be available in Japan. Janssen Pharmaceutica K.K.

Bayer's Novel Oral Anticoagulant Xarelto(R) (Rivaroxaban) Gets European Licence

Today the UK's 160,000 elective hip and knee replacement patients1 will be eligible to receive Bayer Schering Pharma's new oral anticoagulant, rivaroxaban. This follows European Commission authorisation of its licence for the prevention of venous thromboembolism (deep vein thrombosis (DVT) and pulmonary embolism (PE)), in patients undergoing elective hip or knee replacement surgery.

Advaxis Responds To FDA's Questions Phase II Trial Of Lovaxin C For The Treatment Of Cervical Intraepithelial Neoplasia

Advaxis Incorporated (OTCBB: ADXS) has provided a complete response to the FDAs questions regarding the proposed use in humans of Lovaxin C, a live Listeria vaccine directed against HPV induced disease, in the treatment of CIN. Lovaxin C is a bioengineered microbe that infects the immune system and delivers a proprietary protein comprised of an HPV antigen fused to a fragment of the Listeria protein LLO, to stimulate multiple simultaneous immune mechanisms.

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..
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Ziosoft Receives FDA Clearance For CT Brain Perfusion Application

Ziosoft®, Inc., a leader in advanced visualization and analysis software for medical imaging, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CT brain perfusion application. The brain perfusion application is a powerful analysis tool used with the Ziostation thin-client system.

FDA Advisory Committee Provides Opinion On Oritavancin For The Treatment Of Complicated Skin And Skin Structure Infections

Targanta Therapeutics Corporation (Nasdaq: TARG) today announced that oritavancin, the Company's investigational antibiotic therapy for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive pathogens, including methicillin resistant Staphylococcus aureus (MRSA), received a mixed review from the United States Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee.


Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .
In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture.

One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound.
The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material.

Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV.

This step can be repeated in the future in order to produce more of compound III.
Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.

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.

At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.
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.

In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.
US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex.

This company is also developing a family of other promising novel chemical compounds.

Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans.
Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.

Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.
Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef 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.

Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.

Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer.

Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union.
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 individual’s health care needs, developing a wide range of products.

In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.
Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market.

Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations.
Pharmalef Developments is a home for team-oriented professionalsPharmalef 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.

They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities.

They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.
CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008

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. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838

1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.

2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.

3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.

4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.

5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.

6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.

7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.

8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.

9. The method according to claim 8, wherein said head trauma injury is closed head injury.

10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.

11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.

12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.

13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.

14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.

15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.

16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.

17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.

18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.

19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.

20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.

21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.


Viev all historical articles...

ATS Medical Announces Australian Regulatory Approval For ATS 3f Aortic Bioprosthesis

ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for commercialization of the ATS 3f(R) Aortic Bioprosthesis. The Company looks forward to offering this unique tissue valve as the standard of care for the Australian market.

Grunenthal Submits European Marketing Authorisation Application For Centrally Acting Analgesic Tapentadol

German pain expert Grunenthal GmbH announced that it has submitted the Marketing Authorisation Application (MAA) for tapentadol prolonged- and immediate-release (PR/IR) tablets to several European authorities including BfArM (Germany) who will act as Reference Member State for the Decentralised Procedure (DCP). Grunenthal is seeking an indication for the treatment of severe acute and severe chronic pain requiring centrally acting analgesics therapy in adults 18 years and older.

Proposed Treatment For H1N1 Swine Flu Announced By Energex Systems, Inc.

Energex Systems Inc. announced that it has notified the FDA of its interest in applying for an Emergency Use Approval that would permit the company to offer its HemoModulation therapy for the treatment of type A, H1N1, otherwise known as swine flu. HemoModulation therapy was shown to inactivate the virus in mice. This same therapy has been under review by the FDA and is in human clinical trials for Hepatitis C and HIV.

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...
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PharmaEngine Receives Approval Of US IND Application For A Phase II Study Of PEP02 (Liposome Irinotecan Injection) In Pancreatic Cancer

PharmaEngine, Inc. announced today that it has received approval of an Investigational New Drug (IND) application from the U.S. FDA for PEP02, a liposome formulation of irinotecan in a phase II study in patients with metastatic pancreatic cancer. Previous phase I data showed excellent pharmacokinetics, tolerability and efficacy of PEP02 in advanced solid tumor patients in a poster presented at 2008 ASCO Annual Meeting.

New Treatment For Generalized Anxiety Disorder Approved By Health Canada

Health Canada has approved Cymbalta® (duloxetine HCl) for the symptomatic relief of anxiety causing clinically significant distress in patients with generalized anxiety disorder (GAD), Eli Lilly Canada Inc. and Boehringer Ingelheim (Canada) Ltd. announced today.

FDA Near To Gaining Regulatory Control Over Tobacco Products

The American Lung Association cheers the Senate's overwhelming vote in favor of the Family Smoking Prevention and Tobacco Control Act (HR 1256) today. "Today marks an historic culmination of a more than 20 year journey to provide the U.S. Food and Drug Administration (FDA) urgently needed regulatory control over the tobacco industry," said Paul G. Billings American Lung Association Vice President for Policy and Advocacy.

Clinqua Inc. has embraced the concept that cooperation with other aspiring companies is the key to unlocking success in the clinical and biopharmaceutical research industry.

Clinqua is a Contract Research Organization www.clinqua.com that is attempting to change the age old notions that plagued the Clinical and Biopharmaceutical Industry, where in the past it was believed that for a company to survive it had to exist in competition with all others.
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Genentech Submits Application To U.S. Food And Drug Administration For Avastin In The Most Aggressive Form Of Brain Cancer

Genentech, Inc. (NYSE: DNA) announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) as a therapy for people with previously treated glioblastoma. If accepted by the FDA, the application would be considered for an accelerated approval that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.

Ziosoft Receives FDA Clearance For CT Brain Perfusion Application

Ziosoft®, Inc., a leader in advanced visualization and analysis software for medical imaging, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CT brain perfusion application. The brain perfusion application is a powerful analysis tool used with the Ziostation thin-client system.

CMA Applauds Senate Passage Of FDA Tobacco Rules

The California Medical Association supports the passage of the Family Smoking Prevention and Tobacco Control Act that would allow the U.S. Food and Drug Administration to finally set standards for cigarettes and regulate chemicals. In 1963, CMA was the first among state medical societies to create policy to inform people about the harmful effects of cigarette smoking. "California's physicians have been outspoken on the ill effects of cigarettes for over 40 years," said Dr.

Anestvice Pressure Controller (APC) – 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) – device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery...
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CinryzeT Receives FDA Approval For Prophylaxis Against Hereditary Angioedema Attacks

Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB) today announced that the U.S. Food and Drug Administration (FDA) approved CinryzeT (C1 inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency. Cinryze is expected to be commercially available for prophylaxis against HAE later this year.

GlaxoSmithKline Responds To FDA On Cervarix® And Plans To Submit Final Study Data For Approval

GlaxoSmithKline provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of Cervarix®, 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 Warns Consumers Not To Eat Certain Mussel Products From Bantry Bay Seafood

The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. Azaspiracid toxins are odorless, tasteless, and cannot be destroyed or neutralized by freezing or cooking, including boiling.

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...
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France Gives First Approval For Named Patient Supply Of Cerepro(R)

Ark Therapeutics Group plc ("Ark" or the "Company") (AKT:LSE) today announces that the first Named Patient Supply (NPS) for Cerepro® has been approved by the French Medicines Control Agency (AFSSAPS) following a 'nominative' ATU application (Autorisation Temporaire d'Utilisation) made by a neuro-surgeon in France. Cerepro® (sitimagene ceradenovec), Ark's novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma.

Hydroxycut(R) Recalled

The U.S. Food and Drug Administration (FDA) announced the recall of 14 Hydroxycut® supplements due to reports of serious liver damage in patients who took the recommended dosages. Liver damage linked to Hydroxycut® use has resulted in at least one death and one liver transplant. The recalled products are marketed as weight-loss supplements under the Iovate and MuscleTech brand names.

Ark's Trinam(R) Awarded Fast Track Status By FDA

Ark Therapeutics Group plc ("Ark" or "the Company") announces that Trinam® has been awarded Fast Track designation by the US Food and Drug Administration ("FDA"). Trinam® is Ark's novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. This designation covers Trinam® as a treatment for the prevention of de novo stenosis at vascular surgical anastamoses.

Legal Issues in Clinical Research

Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval.
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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.

BioDelivery Sciences Submits REMS For ONSOLIS To FDA For Approval

BioDelivery Sciences International, Inc., (NASDAQ:BDSI) announced that it has resubmitted its New Drug Application (NDA) for the company's lead product ONSOLIST to the Food and Drug Administration (FDA). The company continues to anticipate that the resubmission, which includes a Risk Evaluation and Mitigation Strategy (REMS) for ONSOLIS, will be approved in the first half of 2009.

European Medicines Agency Recommends Update Of Product Information OfTysabri And Risk Of Progressive Multifocal Leukoencephalopathy (PML)

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Tysabri (natalizumab) be updated to further increase awareness about the risk of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS) who have been treated with the medicine. PML is a rare brain infection whose symptoms are similar to those of an MS attack.

Anestvise Inc. is Delivering Quality and Enabling Technology

Anestvice Inc. www.anestvice.com sponsors clinical trials towards manufacture of new medical devices...
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Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .
In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture.

One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound.
The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material.

Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV.

This step can be repeated in the future in order to produce more of compound III.
Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.

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.

At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.
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.

In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.
US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex.

This company is also developing a family of other promising novel chemical compounds.

Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans.
Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.

Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.
Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef 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.

Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.

Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer.

Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union.
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 individual’s health care needs, developing a wide range of products.

In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.
Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market.

Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations.
Pharmalef Developments is a home for team-oriented professionalsPharmalef 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.

They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities.

They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.
CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008

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. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838

1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.

2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.

3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.

4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.

5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.

6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.

7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.

8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.

9. The method according to claim 8, wherein said head trauma injury is closed head injury.

10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.

11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.

12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.

13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.

14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.

15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.

16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.

17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.

18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.

19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.

20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.

21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.

613-686-5745 Clinical training is not a Scam, you should take training courses that are not a scam. Not a clinical trial scam for training in the clinical trail industry. Clinical Research Associate Courses maybe not a scam but not really a scam you learn alot about Clinic trials. Don't tell me its a scam as I think it does not work. Opinions of Clinical Training seem to say these courses are a scam. This is not truly a scam, scams are not good and clinical trails is not one of them. Take Clinical courses and you won't be scammed. Is Clinical Research Associates Training a scam? 613-686-5745

And a pair of them on 800notes.com. pharmaceutical company you hope to one day work for. Similar to comments bearing the same signature and left elsewhere, it includes talk of defamation, and “offensive or harassing content” removing this blog trinity includes a recruiting agency, a pharma company, and a school

INSTITUTIONS THAT OFFERS A PRACTICAL ORIENTED COURSE IN CLINICAL RESEARCH.ClinfoSource online GCP training courses WARN OF ONE INSTITUTE. STAY AWAY. they will help you find a job in India. certificates courses, numerous spelling and grammar mistakes. Looking for clinical research staff nation-wide to prepare and initiate clinical trials. report a fraud. report this scam. moving forward in their clinical trial as it was approved.Espoir and PharmAlef are a complete and utter fraud

qualified for any clinical trials-related positions, but we highly recommend you get a clinical trials certificate. QA experience: GMP, GLP and GCP certificate through the training and certification  programs accredited by the International Biopharmaceutical Association. Certificate form Kriger and Bachelor's degree in science and clinical research experience preferred. I am still interested in pursuing a career in clinical research. 613-686-5745

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