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GlaxoSmithKline, Novartis Found Guilty Of Overcharging Alabama Medicaid Program, Must Pay State $114M

An Alabama state court jury on Tuesday found pharmaceutical companies GlaxoSmithKline and Novartis guilty of defrauding the state Medicaid program by charging artificially high prices for medications and ordered the two companies to pay more than $114 million in restitution, the

According To Cutting Edge Information, Companies Now Outsource Less Of Clinical Development Budget

Pharmaceutical companies across the industry have significantly cut outlays to outsourcing as a percentage of clinical development budgets, according to "Streamlining Clinical Trials," a new study by pharmaceutical business intelligence leader Cutting Edge Information. Comparison with earlier research by Cutting Edge Information in this arena reveals that reductions occur in every phase.

Nontoxic Nanoparticle Can Deliver And Track Drugs

A nontoxic nanoparticle developed by Penn State researchers is proving to be an all-around effective delivery system for both therapeutic drugs and the fluorescent dyes that can track their delivery.

Clinproxy recommends that sponsors use their expertise in creating a budget within their means.

It is a reality that the development of pharmaceutical drugs is a very expensive task. Yet, these costs are necessary due to the substantial investment of both resources and time of the companies in question.
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Covert Promotion Of Off-Label Drug Use

Several techniques are often employed by drug companies to secretly promote off-label use, according to a piece released on October 27, 2008 in the open-access journal PLoS Medicine. For most drugs, it is legal to prescribe them for off-label uses, which are not specified in the original approval of the drug. These uses are sometimes unavoidable -- for instance, most approvals do not include pregnant women, who may need medication.

KMR Group Assesses Discovery Research In Biopharma Industry

KMR GROUP, a firm analyzing biopharmaceutical R&D performance, announces the launch of a Discovery study to assess research performance and identify trends that promise to shape the most successful Discovery organizations of the future. The study is part of the Pharmaceutical Benchmarking Forum's initiatives for 2009 and already has a number of major company participants.

Cell Therapeutics Announces Study Data Set Cut-off For Phase III Pivotal Pixantrone (301) Trial

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that it has closed the data set for preliminary analysis of the primary endpoint in the phase III EXTEND (PIX301) trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL) and it has provided Novartis notice that the data set has been closed.

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
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'What Would You Do With A $10K Genome?' Applied Biosystems Asks The Life Science Industry

As part of its commitment to promote basic research in the life sciences, Applied Biosystems Inc. (NYSE:ABI) today announced the creation of a grant program for genomic, epigenomic and transcriptome studies. The $10K Genome Grant Program is based on the concept of sequencing an entire genome for $10,000. Applied Biosystems is launching this program to inspire new genomic sequencing studies on next-generation sequencing technology.

Mpex Pharmaceuticals Announces Initiation Of A Phase 2 Clinical Trial Of Aerosol MP-376 In COPD

Mpex Pharmaceuticals, Inc. announced that it has initiated a Phase 2 clinical study with MP-376 for use as a maintenance therapy in reducing the incidence of pulmonary exacerbations in patients with chronic obstructive pulmonary disease (COPD). MP-376 is the company's novel formulation of levofloxacin inhalation solution. The Phase 2, U.S.

New Phase II Data Show Safety Of Once-Daily Oral Factor Xa Inhibitor, DU-176b, Comparable To Warfarin

Patients with non-valvular atrial fibrillation receiving either 30 mg or 60 mg once-daily dose of DU- 176b, an investigational oral Factor Xa inhibitor, experienced comparable safety and tolerability compared to those taking warfarin, according to new Phase II data presented at the 50th Annual Meeting of the American Society of Hematology in San Francisco.

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.
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Supreme Court Might Review Whistle-Blower Case That Could Set Limits On Lawsuits Against Drugmakers, Biotech Firms

The U.S. Supreme Court is considering reviewing a case that could set new limits on whistle-blower lawsuits against drugmakers, biotechnology companies and other businesses, Bloomberg reports. The court has asked the Department of Justice for advice on the suit, which alleges that a North Carolina water district fraudulently sought federal money for storm cleanup. The case is based on the U.S.

Free Drug Samples May End Up Costing Uninsured More

Free drug samples provided to physicians by pharmaceutical companies could actually be costing uninsured patients more in the long run, according to a study done by researchers at Wake Forest University Baptist Medical Center and colleagues. The retrospective study looked at the prescribing habits of more than 70 physicians in a university-affiliated internal medicine practice in the months immediately before and after the closing of their drug sample closet.

China Sky One Medical, Inc. Announces 26 New Drugs In Clinical Trials

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Amex: CSY), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), announced that it successfully developed 26 new drugs that are currently in clinical trials. Heilongjiang Tianlong Pharmaceutical, Inc.

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner.
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Charter Medical Introduces Breakthrough Solution For Bio Tech, Pharmaceutical And Cellular Therapy Industries

LYDALL, INC. (NYSE: LDL) Charter Medical Ltd., a subsidiary of Lydall, Inc., has announced a breakthrough Bio-Container that utilizes an innovative new film technology. FREEZE-PAKT Bio-Containers are designed for use in cryogenic temperature applications providing robust performance as low as -196°C and remain flexible in a frozen state.

EMBO Honors 59 Leading Life Scientists

Fifty-nine leading life scientists from Europe and around the world were recognised yesterday by the European Molecular Biology Organization (EMBO) for their proven excellence in research. Fifty-one of the researchers, distinguished as EMBO Members, are from Europe and neighbouring countries, while eight equally respected scientists come from other parts of the world and join as Associate Members, bringing the current membership total to 1360.

Cutting Edge Information Study Finds Pharma Pricing Research Being Conducted Earlier

Pharmaceutical and biotech companies conduct pricing research much earlier in drug development than they once did. The new study, "Outcomes-Based Pharmaceutical Pricing: Meeting Stakeholder Needs," published by competitive intelligence firm Cutting Edge Information, finds that 56% of companies begin pricing-focused market research before Phase III of product development (http://www.

What Clinical Research Is All About

How can researchers prove to the government that a newly-discovered drug or device is safe and effective? This is where the clinical trial comes in. The clinical trial is a research study designed to determine if a new pharmaceutical or medical device is sufficiently safe and effective for human use.
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Institute Of Clinical Research Poster Abstracts Open For 30th Anniversary Conference - Innovation, Research And Operational

Entries are now open for poster abstracts for the 2009 Institute of Clinical Research (ICR) Annual Spring Conference and Exhibition which will focus on Essential Updates and Lively Debates.

Kucinich Introduces Legislation That Seeks To Lower Prescription Drug Costs By Replacing Medicare Part D

Rep. Dennis Kucinich (D-Ohio) recently introduced a bill (HR 6800) that would replace the Medicare prescription drug benefit with a new program in an effort to reduce costs, CQ HealthBeat reports.

Sen. Grassley Sends Letters To Wyeth, Medical Communications Firm Seeking Information About Journal Article

Senate Finance Committee ranking member Chuck Grassley (R-Iowa) on Friday sent separate letters to Wyeth and

Compliance in Developing countries is a balancing act

Clinproxy’s, www.clinproxy.com global spread continues to acknowledge to issues with regards to developing countries and the compliance required for clinical trials.
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Nanoscale Droplets With Cancer-Fighting Implications Produced By Scientists

UCLA scientists have succeeded in making unique nanoscale droplets that are much smaller than a human cell and can potentially be used to deliver pharmaceuticals. "What we found that was unexpected was within each oil droplet there was also a water droplet - a double emulsion," said Timothy Deming, professor and chair of the UCLA Department of Bioengineering and a member of both the California NanoSystems Institute (CNSI) at UCLA and UCLA's Jonsson Cancer Center.

CBO Savings Estimate For Follow-On Biologics Underscores Need For Congress To Move Quickly To Create Pathway For Follow-On Biologics

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the Congressional Budget Office (CBO) report issued projecting cost savings from S. 1695, the Biologics Price Competition and Innovation Act of 2007: "The CBO report shows that developing a pathway to review and approve follow-on biologics will result in cost savings to public and private purchasers of biologic products over a ten year period.

Trubion Reports Re-treatment Results Following Phase 1/2a And Phase 2b Studies Evaluating TRU-015 For Rheumatoid Arthritis

Trubion Pharmaceuticals Inc. (Nasdaq: TRBN) announced positive data from a Phase 1/2a study demonstrating that repeat administration with TRU-015 continues to produce persistent responses and significant improvements in rheumatoid arthritis (RA) signs and symptoms based on American College of Rheumatology (ACR) criteria.

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace.
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Genentech Confirms Receipt Of Proposal From Roche

Genentech, Inc. (NYSE:DNA) announced today that it has received a proposal from Roche to acquire all of the outstanding shares of Genentech stock not owned by Roche at a price of $89.00 in cash per share. Currently, Roche owns approximately 55.9% of the outstanding shares of Genentech.

Drug Information Association (DIA) Opens New Office In China

The Drug Information Association (DIA), the premier, multidisciplinary, non-profit association that provides a neutral forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes, has opened an office in Beijing, China. "China's pharmaceutical industry has become a major force in drug discovery and development," explains William Brassington, Acting DIA Worldwide Executive Director.

Rib-X Pharmaceuticals Reports Positive Top-Line Results From Phase 2 Study Of Delafloxacin

Rib-X Pharmaceuticals, Inc. ("Rib-X" or the "Company"), a development-stage company focused on the discovery, development and commercialization of novel antibiotics for the treatment of antibiotic-resistant infections, announced positive topline results from a Phase 2 clinical trial with the intravenous form of its novel anionic quinolone antibiotic, delafloxacin (RX-3341).

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

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

Scientists at the National Institute of Standards and Technology (NIST) have developed a technique to measure the formation of clumps of proteins in protein-based pharmaceuticals. This first systematic study clarifies the conditions under which scientists can be assured that their instruments are faithfully measuring the formation of protein aggregates, a major concern because of its impact on quality control and safety in biologic drug manufacturing.

Resistance To Use Of Generic Medications By Physicians 'Discouraging,' Editorial States

"Health care reformers have high hopes that the relentless rise in prescription drug costs can be slowed by replacing brand-name medicines with cheaper generic versions," but "so many physicians are so captive of the drug industry that it would take a huge effort to persuade more patients and doctors to use generics," a New York Times editorial states.

Medicaid Paid Nearly $198M For More Than 100 Unapproved Drugs From 2004-2007, According To AP Analysis

Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved prescription drugs for beneficiaries, according to an Associated Press analysis of federal data, the AP/San Francisco Chronicle reports.

Limdato’s Grasp On Streamlining Clinical Trials

Limdato, www.limdato.com understands that executing a successful clinical trial requires a seamless coordination and communication with all individuals involved on levels on the trial
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Sanofi-aventis And Bristol-Myers Squibb Back NICE's Decision To Review Guidance On Vascular Disease - New Evidence Could Affect Change In Guidance, UK

Sanofi-aventis and Bristol-Myers Squibb back today's decision by NICE (the National Institute for Health and Clinical Excellence) to review its guidance on vascular disease for clopidogrel (Plavix®) and dipyridamole. NICE originally planned to defer review of the guidance, called Technology Appraisal Number 90 (TAG90), until November 2010. During the recent NICE consultation process, a number of organisations, highlighted the pressing need for an earlier review.

Japanese Technology Showcase 2009: Global Access To Japanese Innovations In The Physical And Life Sciences

Nagoya University and Japan Science and Technology Agency (JST), will present an innovations event entitled "Next Generation Japanese Technology Showcase" to be held on January 14th, 2009 at the Cornell Club New York in Mid-town Manhattan. The showcase will feature early to advanced stage developments in the fields of physical and life sciences from several prominent Japanese universities.

JAMA Commentary Examines Terminally Ill Patients' Access To Experimental Drugs

"Access to Experimental Drugs for Terminally Ill Patients," Journal of the American Medical Association: In the commentary, Benjamin Falit and Cary Gross of the Robert Wood Johnson Foundation Clinical Scholars Program and Yale University's

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

The research was conducted on 24 patients ranging in age from 13 to 74 years (the average age was 46.6 ±5.4), who underwent surgery in the urology clinic of the Rostov State Medical University. It was sponsored by Anestvice Inc...
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Helix Receives Approval To Open Sites In Germany For Its Ongoing Clinical Trial With Topical Interferon Alpha-2b In Patients With Ano-Genital Warts

Helix BioPharma announced that it has received the necessary regulatory approvals to open clinical sites in Germany to expand upon its clinical trial with Topical Interferon Alpha-2b in patients with ano-genital warts, which is presently underway in Sweden. "We are pleased to have received approval to open these additional clinical sites," said John Docherty, President of Helix BioPharma.

Pain Therapeutics Receives Complete Response Letter From FDA For REMOXY(R)

DURECT Corporation (Nasdaq: DRRX) reported that Pain Therapeutics, Inc. (Nasdaq: PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY(R), an abuse-resistant controlled-release form of oxycodone. Based on its review, the FDA has determined that the NDA is not approved in its present form. According to King Pharmaceuticals, Inc.

Chemical Society To Honor 'Heroes Of Chemistry' During National Meeting

Bruce Roth's name may not be on the tip of many tongues, but his invention has been on more than 26 million in the United States alone. Inventor of Lipitor, the cholesterol-lowering pill that is the world's largest selling drug, Roth is among 25 unsung scientific heroes who are being inducted into an American Chemical Society (ACS) hall of fame called the Heroes of Chemistry. The other new Heroes include Karen E.

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...
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SuperGen's PIM Kinase Inhibitor, SGI-1776, Effective In Pre-Clinical Models Of Acute Lymphoblastic Leukemia

SuperGen Inc. (Nasdaq: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that its oral PIM kinase inhibitor, SGI-1776, is effective both in vitro and in vivo in preclinical models of acute lymphoblastic leukemia (ALL) (Abstract #1922). This research was presented at the 50th Annual Meeting of the American Society of Hematology.

Merck Serono's Erbitux Nominated For International Prix Galien Award - Transforming Head And Neck Cancer Treatment

Merck Serono's Erbitux® is one of the finalists for the prestigious International Prix Galien Award for excellence in pharmaceutical development and innovation due to its role in transforming the treatment of head and neck cancer. Erbitux is the first and only targeted therapy approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN) and works in a completely different way to conventional chemotherapies.

HIV/AIDS Drug Access Problems In Mozambique Cannot Be Solved Solely Through Antiretroviral Plant, Health Official Says

A pharmaceutical plant in Mozambique's capital of Maputo that will produce generic antiretroviral drugs cannot be the sole solution to problems associated with access to treatment, Health Minister Ivo Garrido said recently, AIM/AllAfrica.com reports.

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.
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Novavax Announces Preclinical Data For Respiratory Syncytial Virus Vaccine Candidate

Novavax, Inc. (Nasdaq: NVAX) announced that Dr. Trudy Morrison, PhD, Professor of Molecular Genetics and Microbiology, University of Massachusetts Medical School, will be presenting the results of a preclinical study of a vaccine candidate for the prevention of respiratory syncytial virus ("RSV") at the 2nd Vaccine Congress in Boston, MA on December 9, 2008. This study was funded by Novavax, Inc.

Sea Lane Biotechnologies Unveils A Potential New Class Of Biotherapeutics

Sea Lane Biotechnologies, LLC (Sea Lane) announced the first demonstration of a new class of biotherapeutic molecules called SurrobodiesT with the potential to impart transformative new abilities and benefits into next generation biologic treatments. Surrobodies build upon the increasing success of biotherapeutic antibodies whose sales in the US total more than $16 billion annually and are growing rapidly.

New Paradigm For Medicinal Chemistry Offered By International Public-Private Partnership

The Wellcome Trust has announced a £4.1 million investment in a new initiative to generate small molecule inhibitors - "chemical probes" - for 25 proteins involved in epigenetic signalling, and to release these probes into the public domain with no restriction on use. Early stage information sharing on chemical probes is highly unusual and breaks with the tradition of keeping such data confidential.

Limdato’s Grasp On Streamlining Clinical Trials

Limdato, www.limdato.com understands that executing a successful clinical trial requires a seamless coordination and communication with all individuals involved on levels on the trial
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CHMP Recommends Approval In The European Union (EU) For New Options For Patients With Certain Primary Brain Tumors

Schering-Plough Corporation (NYSE: SGP) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of the intravenous (IV) formulation of TEMODAL(R) (temozolomide) as an alternative to the already approved oral form of temozolomide in the EU. The CHMP also has issued a positive opinion recommending approval of a sachet packaging presentation for TEMODAL Capsules.

Among Older Adults, Prescription And Over-the-Counter Medications Are Commonly Used Together

A survey suggests that nearly half of older adults in the U.S. use prescription and over-the-counter medications together, and that about 4 percent of older adults are potentially at risk of an adverse drug reaction because of an interaction between medications, according to a study in the December 24/31 issue ofJAMA. The researchers also found that nearly 30 percent use at least 5 prescription medications.

Genentech Special Committee Of Independent Directors Responds To Roche Proposal

The special committee of the Board of Directors of Genentech, Inc. (NYSE:DNA) announced that, after careful consideration, it has unanimously concluded that Roche's proposal to acquire the shares of Genentech not owned by Roche for $89.00 per share substantially undervalues the company. Therefore, the special committee does not support the proposal.

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.
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New PhRMA Guidelines Ban Gifts To Physicians From Drug Company Marketing Campaigns

Pharmaceutical Research and Manufacturers of America on Thursday is expected to announce new voluntary guidelines prohibiting gifts to doctors as part of pharmaceutical companies' marketing efforts, the New York Times reports.

DIA's Pharmacovigilance And Risk Management Conference To Address Current Complexities And Controversies

The Drug Information Association will host its 8th Annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies (January 11-15; Washington, DC).

8,000 Pharmaceutical Scientists To Gather In Atlanta For The American Association Of Pharmaceutical Scientists' Annual Meeting And Exposition

On November 16-20, 2008, 8,000 of the world's most prominent pharmaceutical scientists will put their best research on paper and present their findings at the AAPS Annual Meeting and Exposition. This year's meeting will take place in Atlanta at the Georgia World Congress Center.

The World Is Getting Better!

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

From pharmaceutical company funding to the mentioning of brand name medications, there are several potential sources of bias in medical news media coverage. According to a report published in the October 1 issue of JAMA, news articles frequently fail to report these sources of bias and other conflicts of interest. Both physicians and laymen consider news articles an important source of medical information. Michael Hochman, M.D.

States Consider Legislation To Restrict Access To Physician Prescribing Information For Data Mining Companies

A number of states have begun to consider legislation that would restrict access to physician prescribing information for data mining companies as part of a "backlash against pharmaceutical marketing efforts," the AP/Arizona Republic reports. Data mining companies, such as

Switchable Bio-Adhesion

Researchers have developed a new type of property-changing polymer: It is water-repellent at 37 degrees Celsius, which makes it an ideal culture substrate for biological cells. At room temperature it attracts water, allowing the cells to be detached easily from the substrate.

In the United States, CROs receive an estimated 60% of the clinical research outsourced from pharmaceutical companies.

Typically, large CROs compete on the basis of medical and scientific expertise in specific therapeutic areas; the ability to manage large-scale trials on a global basis with strategically located facilities
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Animal Testing - MEP Wants Law Changed, Duplicate Experiments Mean Too Many Animals Suffering, Europe

Plaid MEP Jill Evans (Wales) believes a twenty year old European law on animal testing is in urgent need of updating because it allows too many animals to suffer unnecessarily. The MEP says many experiments are being duplicated, leading to animal suffering that could be avoided. The MEP wants the European Commission to establish a Europe-wide database, accessible to researchers, to help reduce the number of animals suffering in experiments.

TheraQuest's IND For Abuse Deterrent Strong Opioid (TQ-1015) Accepted By FDA

TheraQuest Biosciences, Inc. a development stage pain management company announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug ("IND") application for TQ-1015, its abuse deterrent extended release strong opioid. TQ-1015 is being developed using SECUREL(R), TheraQuest's proprietary abuse deterrent technology.


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.


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