Many receptor models used in drug design may not be useful after all It may very well be that models used for the design of new drugs have to be regarded as impractical. This is the sobering though important conclusion of the work of two Leiden University scientists published in Science this week. The editorial board of the renowned journal even decided to accelerate the publication on the crystal structure of the adenosine A2A receptor via Science Express.
Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced new findings regarding the correlation between serologic markers and the diagnostic predictions of children with Crohn's disease following an analysis of PROMETHEUS(R) IBD Serology 7 test results.
Converging Nanotechnology and the Life Science Industry Wednesday 11th February 2009, London The Nanotechnology Knowledge Transfer Network (NanoKTN), one of the UK's primary knowledge-based networks for Micro and Nanotechnologies, has announced that their first Nano 4 Life event will take place on Wednesday 11th February hosted by The Wellcome Trust in London.
Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsor’s budget. (613) 686-5745 Cerepotec Pharmalef
The U.S. Supreme Court on Monday heard opening arguments in Wyeth v. Levine, a case that could determine whether patients have the ability to file product liability lawsuits against pharmaceutical companies in state courts (Kaiser Daily Health Policy Report, 11/4).
FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft report compiled by the Government Accountability Office, the
EuropaBio, the European Biotech Industry Association, acknowledges the review of Directive 86/609, the laboratory animal protection Directive, but calls for a reduction of the bureaucratic burden the Directive places on SMEs. The legislation updates the rules and standards for breeding, use, housing and care of laboratory animals which were adopted over twenty years ago and now need to reflect advances in science and technology.
GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta based biotechnology company, developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced it has shipped both DNA and MVA components of its AIDS vaccine to the HIV Vaccine Trials Network (HVTN) pharmacy, for use in the upcoming Phase 2a human clinical trial. This Phase 2a study will involve 150 vaccinees and 75 placebo (control) participants.
Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, presented data showing the investigational drug, Contrave(R) (naltrexone SR / bupropion SR), successfully achieved key objectives (lowered naltrexone Cmax, increased Tmax, comparable AUC) in two Phase 1 clinical trials.
Fitch Ratings has affirmed Eli Lilly and Co.'s (Eli Lilly) ratings as follows: --Issuer Default Rating (IDR) 'AA'; --Bank loan 'AA'; --Senior unsecured debt 'AA'; --Short-term IDR 'F1+'. The Rating Outlook is Stable. The ratings apply to approximately $4.61 billion of outstanding debt.
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. (613) 686-5745 Cerepotec Pharmalef
On 1 July 2008, a new Code of Practice comes into effect across Europe to ensure relationships between the pharmaceutical industry and patient organisations are transparent and ethical. The "Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations", adopted in October 2007, applies to the 2,200 companies that the European Pharmaceutical Industry Association EFPIA represents directly and indirectly in 31 European countries.
GlaxoSmithKline (NYSE: GSK) announced findings from a cross-sectional study which showed that 26 percent of primary care patients 40 years of age and older with a history of smoking and symptoms of chronic bronchitis actually had airway obstruction consistent with chronic obstructive pulmonary disease (COPD) - yet were not diagnosed with the disease.
A Web portal providing U.S. physicians with access to free, accredited CME courses about pharmaceutical industry marketing techniques and their effect on prescribing practices has been expanded to include additional courses. The
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. (613) 686-5745 Cerepotec Pharmalef
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.
After failure of 1st generation thrombopoietic growth factors due to immunogencity, the 2nd generation is focused on oral TPO mimetics, now followed by a 3rd generation of engineered biologics with potential for higher potency and efficacy The Business Intelligence firm La Merie S.L. reported in its most recent pipeline update of thrombopoiesis stimulating agents that eight thrombopoietin (TPO) mimetics are in clinical stages of development.
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.
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"With a liberal supermajority in Washington increasingly possible," the pharmaceutical industry is "trying to buy up protection in the hopes that Democrats will go easier on them," a
The three finalists of the 2008 EUROPEAN BIOTECHNICA AWARD have been determined. The biotechnology companies nominated are Cambridge-based Astex Therapeutics Limited (UK), GENEART AG from Regensburg (Germany) and immatics biotechnologies GmbH based in Tübingen (Germany). The prize, worth EUR 100,000, is awarded to innovative European biotechnology and life sciences companies.
U.S. Senator Herb Kohl (D-WI), Chairman of the U.S. Special Committee on Aging, reacted to the release of a new voluntary code of conduct by the Pharmaceuticals Research and Manufacturers Association (PhRMA), the drug industry's foremost trade association. Kohl is behind several initiatives to force greater transparency in the way drug companies interact with doctors, in an effort to curb spiraling prescription drug costs.
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. (613) 686-5745 Cerepotec Pharmalef
Drug molecules seldom act simply on one protein but on protein complexes and networks. A deeper understanding of these 'cooperative assemblies' should lead to better targeting of drugs New research into how proteins in human cells interact and 'talk' to each other is leading to a better understanding of how drug molecules work and should result in more effective therapies, according to a leading European scientist.
The Medicare Payment Advisory Commission on Thursday adopted five recommendations to Congress that would require disclosure of the health care industry's financial ties to physicians and other health care professionals, CQ HealthBeat reports. MedPAC will present the recommendations to Congress in March.
"A spoonful of sugar helps the medicine go down" -- parents know in reality it just isn't that easy. That's why Insight Pharmaceuticals has introduced Sucrets(R) ICE -- unique, frozen single-use packages that offer cooling, soothing relief to both children's and adults' harshest sore throats. Sucrets ICE is the newest member of the Sucrets family of products that has been trusted by doctors and moms for more than 75 years.
CROs were first organized as outsourcing service companies that provided only clinical trial management. Today, many CROs have expanded their scope of services to provide comprehensive management of the complex drug trial processe (613) 686-5745 Cerepotec Pharmalef
An innovative plan to get new life-saving drugs into the hands of millions of people around the world who need medicines but can't afford the massive costs will be unveiled to key decision makers in London and Washington over the coming weeks.
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for cancer and serious viral infections, today announced that it has completed enrollment in the first stage of its Phase II trial evaluating a combination regimen of bavituximab with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC).
When chemists want to produce a lot of a substance -- such as a newly designed drug -- they often turn to catalysts, molecules that speed chemical reactions. Many jobs require highly specialized catalysts, and finding one in just the right shape to connect with certain molecules can be difficult. Natural catalysts, such as enzymes in the human body that help us digest food, get around this problem by shape-shifting to suit the task at hand.
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. (613) 686-5745 Cerepotec Pharmalef
Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and severity of delayed graft function (DGF) in patients undergoing solid organ transplantation. Ralf Rosskamp, M.D.
The United States (U.S.) Court of Appeals for the Federal Circuit has issued a ruling that affirms the preliminary injunction ordered by the U.S. District Court in Boston barring Roche from selling its pegylated-erythropoietin (peg-EPO) product MIRCERA in the U.S.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time.
The process of clinical trials can be costly to say the least. Clinical affairs consumes an average of 37% of R&D budgets. (613) 686-5745 Cerepotec Pharmalef
A recent breakthrough was published in the scientific journal In Vitro Cellular & Developmental Biology showing the benefit of using recombinant lactoferrin (Lacromin) to promote growth of HEK 293 cells using a serum-free and animal-free media. Lactoferrin is a protein derived from colostrum and has been made using recombinant techniques in an animal-free system by InVitria (see Lacromin). HEK 293 cells are used by biotechnology and biopharmaceutical companies to produce human therapeutics.
Boston Scientific Corporation (NYSE: BSX) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Express2(TM) Atom(TM) Paclitaxel-Eluting Coronary Stent System. The TAXUS Express Atom Stent is a highly deliverable drug-eluting stent (DES) specifically designed for treating small coronary vessels. It is the only DES approved by the FDA for use in vessels as small as 2.25 mm in diameter. No other DES for sale in the U.S.
Sandoz has received a positive opinion from European regulators for its third biosimilar medicine, filgrastim, marking another important milestone in its efforts to bring affordable high-quality biopharmaceuticals to patients worldwide. Filgrastim is indicated for use in treating neutropenia, a condition characterized by lack of neutrophils - one of the most common types of white blood cells - that is often associated with chemotherapy or bone marrow transplants.
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UQ researcher Dr Shizhang Qiao is working on developing a new self-assembly technology to synthesise new nanoparticles for selective separation of biomolecules. Working at the
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.
Attorney General Martha Coakley's office, along with 32 other attorneys general, reached a record $62 million settlement with Eli Lilly and Company (Eli Lilly) resolving allegations of improper marketing of the atypical antipsychotic drug, Zyprexa. It is the largest ever multi-state consumer protection-based pharmaceutical settlement, following closely on the heels of the May 2008, $58 million settlement agreement with Merck regarding its product, Vioxx.
Damage to the nervous system may result from traumatic injury, such as penetrating or blunt trauma, stroke, or neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), diabetic neuropathy or senile dementia... (613) 686-5745 Cerepotec Pharmalef
The U.S. Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE) a contract to develop Quality by Design guidance on design space specifications. The intention of this award is development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology.
FDA by itself cannot guarantee drug safety and state-level lawsuits are "a vital deterrent" to help protect consumers against drugmakers that do not disclose all risks associated with a treatment, editors of the New England Journal of Medicine wrote in a friend-of-the-court brief on Thursday, the
As part of a broader congressional investigation into the possible influence of the pharmaceutical industry on physicians and the health care industry, Senate Finance Committee ranking member Charles Grassley (R-Iowa) on Friday sent separate letters to Wyeth and the medical communication company DesignWrite about the hormone-replacement therapy drug Prempro, the
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The U.S. Pharmacopeial (USP) Convention's 2008 Annual Scientific Meeting (ASM) will be held in Kansas City, Mo., September 24 to 26. The meeting is an opportunity to interact with the USP experts responsible for establishing internationally recognized standards for prescription and over-the-counter medicines, food ingredients and dietary supplements. The focus will be on Quality of Manufactured Medicines, Food Ingredients and Dietary Supplements.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the malignant melanoma drug market, driven by the launch of emerging agents, will experience robust annual 12 percent growth through 2012 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
University of Queensland research into how hospital doctors prescribe medication is leading to safer patient outcomes. Dr Ian Coombes, a trained pharmacist, undertook research into safe prescribing practices for junior doctors as part of his PhD with UQ's Schools of Pharmacy and
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 (613) 686-5745 Cerepotec Pharmalef
United Nations Secretary-General Ban Ki-moon on Thursday said that many large pharmaceutical companies -- including Abbott Labs, Boehringer Ingelheim, GlaxoSmithKline and Pfizer -- plan to increase their efforts to develop HIV/AIDS drugs and diagnostics for impoverished regions, Reuters reports.
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
Mylan on Wednesday announced a deal with Indian drug maker Famy Care to develop and sell 22 generic oral contraceptive products, the Pittsburgh Tribune-Review reports (Stouffer, Pittsburgh Tribune-Review, 8/7). Mylan plans to seek
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. (613) 686-5745 Cerepotec Pharmalef
Eisai Inc. and Pfizer Inc (NYSE: PFE) announced results from a new open-label study that showed Hispanics with mild to moderate Alzheimer's disease (AD) experienced significant improvement in cognition compared to baseline after 12 weeks of treatment with ARICEPT. This is the first clinical trial looking at an AD prescription medication exclusively in Hispanics, and is important given the high risk of AD among this large population.
Novavax, Inc. (Nasdaq: NVAX) and the University of Massachusetts Medical School announced results from a preclinical study of a Respiratory Syncytial Virus ("RSV") vaccine candidate. Novavax has licensed exclusive worldwide rights from the University of Massachusetts Medical School to certain technology for the development and commercialization of Paramyxovirus vaccines incorporating certain Virus-Like-Particles ("VLPs").
A new report co-authored by Manhattan Institute senior fellow Benjamin Zycher, and Joseph DiMasi, and Christopher-Paul Milne, researchers from the Tufts Center for the Study of Drug Development, examines case histories for thirty-five important pharmaceutical innovations. Skeptics of the private industry assert that the development of new medicines is most attributable to publicly funded sources.
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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, will host the 8th Middle East Regulatory Conference (20-21 January 2009; Manama, Bahrain).
Dear Healthcare Professional, Restrictions on the import of unlicensed Melatonin products following the grant of a marketing authorisation for Circadin 2mg tablets At the beginning of June 2008, a licensed modified release melatonin product, Circadin (Lundbeck), became available in the UK.
Paratek Pharmaceuticals, Inc. announced the Company's lead product, amadacycline, formerly PTK 0796, a first-in-class aminomethylcycline, will be the subject of a Late Breaker poster presentation at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). ICAAC will be held in Washington, D.C. from October 25 - October 28, 2008. About Paratek Pharmaceuticals Paratek Pharmaceuticals, Inc.
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. (613) 686-5745 Cerepotec Pharmalef
On 2nd March 2009, some 40 senior-level pharmaceutical leaders will gather together in Barcelona Barcelona to discuss the drivers for change in pharma and how they can move and change quickly to sustain growth in these turbulent times. The event has been born out of the huge pressures pharma is facing right now: pricing pressures; increasing payor power and decreasing prescriber power; and the mounting stress on margins.
The law firm of Izard Nobel LLP, which has significant experience representing investors in prosecuting claims of securities fraud, announces that a lawsuit seeking class action status has been filed in the United States District Court for the Southern District of New York on behalf of those who purchased Biovail Corporation ("Biovail" or the "Company") (NYSE: BVF) between December 14, 2006 and July 19, 2007, inclusive (the "Class Period").
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2,400 leaders from the biotechnology and pharmaceutical industry gathered last week for the 14th annual BIO-Europe partnering conference, which saw an astounding 10,250 one-to-one partnering meetings between industry dealmakers. More complete coverage of the event can be found at here. The conference drew over 1,350 companies from almost 50 countries around the world.
Iressa's sales are poised to increase on positive clinical results suggesting that AstraZeneca's targeted lung cancer therapy performs better than standard chemotherapy in many patients, according to a new report, "Oncology Market Forecast to 2013", published by pharmaceutical business intelligence leader Cutting Edge Information.
Reflecting the continuing commitment of America's pharmaceutical research and biotechnology companies to pursue policies and practices that best serve the needs of patients and the healthcare community, the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors has adopted measures to enhance the PhRMA Code on Interactions with Healthcare Professionals. The newly revised
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. (613) 686-5745 Cerepotec Pharmalef
A Boston program through which city workers can buy low-cost Canadian prescription drugs will receive its last shipment of drugs in December, after the Canadian drug supplier terminated its involvement because of a lack of participants, the Boston Globe reports.
Research led by Dr. David Spence of Robarts Research Institute at The University of Western Ontario shows that with more intensive medical therapy, the risk of stroke has become so low that at least 95 per cent of patients with asymptomatic carotid stenosis (ACS) would be better off with medical therapy than with surgery or stenting. ACS is a narrowing in the carotid artery, which supplies blood to the brain, which has not yet resulted in a stroke or transient ischemic attack (TIA).
Geneart AG from Regensburg, Germany, is the winner of the 2008 EUROPEAN BIOTECHNICA AWARD. Second place went to immatics biotechnologies GmbH from Tübingen, Germany, while the third prize was awarded to Astex Therapeutics Limited from Cambridge, UK. The aim of the award - which is now worth a total of 100,000 Euros in prizes - is to celebrate the achievements of innovative European companies in the field of biotechnology and the life sciences.
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... (613) 686-5745 Cerepotec Pharmalef
At the opening of the BIO-Europe 2008 Partnering Conference, Roche, Merck Serono and Abbott announced today to join forces in the development of the Biotechnology Cluster Rhine-Neckar (BioRN) towards a leading position in the field of medical biotechnology in Europe. The BioRN cluster was recently awarded a 40 million euro federal grant by the German Ministry for Education and Research as one of the top five high-tech clusters in Germany.
Indian generic pharmaceutical company Cipla recently received full FDA approval to sell and market in the U.S. an oral generic version of the antiretroviral drug zidovudine, the Drug Industry Daily reports. Cipla's application for zidovudine was considered under the expedited review provisions of the
The field of medical product safety continues to grow in complexity, with both clinical trial safety and post-marketing pharmacovigilance becoming ever more critical in the development and marketed use of medical products. In response, the Drug Information Association (DIA) will host
Clinproxy, www.clinproxy.com fully understands the issues, laws risks and best practices relating to disclosures of confidential information about clinical trials. (613) 686-5745 Cerepotec Pharmalef
Frost & Sullivan recently hosted its prestigious 'Excellence in Healthcare' Awards Banquet at the Excelsior Hotel in Cologne, Germany. Awards presented on the night recognise the quality and merit of companies active in a diverse range of Healthcare sectors, including Patient Monitoring, Obesity Surgery Devices, Laboratory Information Systems, Trans-Dermal Drug Delivery, Wound and Pain Management, Dental Implant and Bioinformatics.
The FDA have confirmed they will be providing an insight into Polymorphic Forms in Abbreviated New Drug Applications (ANDAs). Andre Raw, Ph.D, Senior Regulatory Chemist at the Office of Generic Drugs, based at the Centre of Drug Evaluation and Research (CDER) will be delivering the information via a presentation at the 6th annual IQPC Polymorphism & Crystallisation conference which takes place 11-13th March 2009 in London. Dr.
Roche brought together more than 70 leading experts from research institutes and universities across Asia at its second Drug Delivery Symposium held in Shanghai, China early in December. The invited academics were selected for their leading-edge, innovative research that could contribute to solving numerous challenges in delivering drugs ranging from existing small molecules to future siRNA therapeutics.
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. (613) 686-5745 Cerepotec Pharmalef
The Pharmaceutical Society of Australia (PSA) supports the National Drugs and Poisons Schedule Committee (NDPSC) decision to maintain the current scheduling status for ibuprofen-codeine combination pain-relief products while it considers potential limits to pack sizes. The NDPSC publicly released the results of decisions made at its June meeting. The record of reasons can be
Tickets are now on sale for eyeforpharma's Patient Adherence, Persistence and Compliance USA Summit, October 23-24, Boston and are selling out fast. Last year the event sold out with over 200 delegates, a ratio of 80% pharma and over 90% positive feedback. The chairman has been announced recently as Daryl J.
Omeros Corporation announced favorable results from a Phase 1 vehicle-controlled study of OMS201, another of Omeros' PharmacoSurgery(TM) product candidates, for use during urological surgery. The Phase 1 study of OMS201 enrolled patients undergoing endoscopic removal of urinary stones, and was designed to evaluate the systemic absorption and safety of the drug product.
As a drug makes its way through the different phases of pre-clinical and clinical trials in human testing, the public and the company can rest assured that their product has been thoroughly tested and that each... (613) 686-5745 Cerepotec Pharmalef
Nile Therapeutics, Inc. (Nasdaq: NLTX), announced interim data from its multi-center, open-label Phase 2a clinical study of CD-NP, a novel chimeric natriuretic peptide, in patients hospitalized for acute heart failure.
Canada's biotechnology CEOs are calling for an economic stimulus package that includes targeted measures designed to protect $1.7 billion of annual spending and preserve high-value "21st century" jobs in Canada in the face of a severe economic times.
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.
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... (613) 686-5745 Cerepotec Pharmalef
Schering-Plough Corp., (NYSE: SGP), a leading provider of fertility treatments, announced today that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS). This application will follow the Centralized Procedure.
FDA's approval process and postmarket oversight of Danco Laboratories' medication abortion drug Mifeprex, also known as RU-486, were "consisten[t]" with how the agency handles other drugs with restricted distribution, according to a Government Accountability Office report released Tuesday,
An "intensifying focus on safety and a diminished tolerance for side effects" by FDA have "dramatically lowered" the chances that experimental medications will reach the market and have led to a recent decrease in approvals of new treatments, according to pharmaceutical companies, the Wall Street Journal reports.
Professor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage... (613) 686-5745 Cerepotec Pharmalef
Roche announced that ample supplies of its prescription antiviral medication Tamiflu (oseltamivir phosphate) will be widely available throughout the U.S. this flu season. Tamiflu, cited by the Centers for Disease Control and Prevention (CDC) as an important second line of defense against flu, is indicated for the treatment and prevention of influenza in adults and children one year and older.
Pfizer Inc (NYSE: PFE) and Medivation, Inc.(NASDAQ: MDVN) announced today that they have entered into an agreement to develop and commercialize Dimebon, Medivation's investigational drug for treatment of Alzheimer's disease and Huntington's disease. Dimebon currently is being evaluated in an international, confirmatory Phase III trial in patients with mild-to-moderate Alzheimer's disease (http://www.connectionstudy.
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Peptimmune, Inc. a privately held biotechnology company, announced today the grant of US Patent Number 7,381,790 (the '790 patent) which protects the composition of matter for its PI-2301 peptide copolymer for the treatment of autoimmune diseases. PI-2301 is currently in a Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study in subjects with multiple sclerosis.
Representatives from international regulatory agencies, industry, and academia will meet in Buenos Aires, Argentina on November 20-21 at the Drug Information Association's (DIA's) 5th Latin American Congress of Clinical Research. Many factors have contributed to the increased number of clinical trials being conducted throughout Latin America.
As partnering transactions continue at record-breaking rates and deals continue as the defining industry trend, the critical question confronting big pharma is not if they should embrace earlier stage deals, but how to best take advantage of them. As the top 20 big pharma companies attend
The draft recommendations announced today by NICE in the second technology appraisal consultation document (ACD) suggest that Tyverb (lapatinib) should not be used in the NHS, except in clinical trials. "Given our involvement, it is difficult to comment without the appearance of self interest, however we strongly believe that the wrong decision has been made for patients, doctors and the NHS," said Simon Jose, General Manager for GSK UK Pharmaceuticals.
Athera Biotechnologies AB and Dyax Corp. (NASDAQ:DYAX) announced that they have entered into a collaboration to discover and to develop therapeutic products for the prevention or treatment of cardiovascular inflammatory diseases. The collaboration follows the recent publication of work by Athera scientific founders, Professors Frostegard and de Faire of the Karolinska Institutet.
In an ever growing global market of supply and demand, it remains unimaginable to engage in practices that are ambitiously expensive when there are endless opportunities to utilize more appropriately priced methods which would in turn yield the same results. T (613) 686-5745 Cerepotec Pharmalef
Raptor Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board: RPTP), announced the initiation of patient dosing in a Phase 2a clinical trial, in collaboration with the University of California, San Diego ("UCSD"), to evaluate cysteamine bitartrate ("cysteamine") in adolescents diagnosed with Non-alcoholic Steatohepatitis ("NASH").
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.
Research and Markets has announced the addition of Decision Resources, Inc.'s new report "Women's Health Series: How Have New Oral Contraceptives Changed the Market" to their offering. Introduction The oral contraceptive market is mature, with a high level of competition and a stable patient population. Dozens of oral contraceptives are available worldwide; most are comparable in terms of efficacy in their primary indication (preventing pregnancy) and safety.
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The US Food and Drug Administration (FDA) has approved a 30-minute onset of action for Focalin(R) XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), bringing potential benefits for young patients and their families during the important morning period when they are preparing for school.
Both Democratic presidential nominee Sen. Barack Obama (Ill.) and Republican presidential nominee Sen. John McCain (Ariz.) support prescription drug reimportation but cite the need to ensure the safety of medications purchased from other nations,
CV Therapeutics, Inc. (Nasdaq: CVTX) announced that the company has enrolled the first patient in a Phase 1 trial of CVT-3619, a novel oral compound for potential treatment of cardiometabolic diseases. The U.S. Food and Drug Administration recently accepted the Company's investigational new drug application for CVT-3619, a partial A1 adenosine receptor agonist.
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... (613) 686-5745 Cerepotec Pharmalef
Pharmaceutical companies have slashed more than 6,000 U.S. sales reps from their ranks in 2008, and additional field sales force cutbacks are expected in early 2009 as companies continue to implement cost-cutting measures. These cutbacks come on the heels of several studies showing that oversized field sales forces have saturated the market and that physicians are increasingly reluctant to see reps in their offices.
Historically, bile acids have been recognized primarily as natural detergents that regulate the absorption of dietary lipids and cholesterol homeostasis. However, recent research advances provide evidence that bile acids have broader systemic endocrine functions, acting as important mediators of glucose metabolism and insulin signaling. The featured article in the current issue of Nature Reviews Drug Discovery (Vol.
Programming biological cells so that they behave like engineering parts is the focus of research at a new UK centre launched today, thanks to an £8 million grant from the Engineering and Physical Sciences Research Council (EPSRC). The new centre will focus on synthetic biology. This is a field in which engineers work with molecular bioscientists to produce biologically-based parts, by modifying DNA.
According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. (613) 686-5745 Cerepotec Pharmalef
Personalized medicine -- the ability to predict how patients will react to certain medications based on their genetic profiles -- will lead to changes in clinical trials and the business model for the pharmaceutical industry, as well as the FDA approval process for new treatments, agency commissioner Andrew von Eschenbach said on Friday during a speech to business students at St.
Minnesota U.S. Senate Democratic candidate Al Franken on Wednesday said the federal government should negotiate with drug companies to lower seniors' drug prices, permit re-importation of prescription medications from other countries and ban mass-market drug advertising, the St. Paul Pioneer Press reports.
VIA Pharmaceuticals, Inc. (Nasdaq: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular disease, announced that it has completed the last patient visit in its Phase 2 acute coronary syndrome (ACS) study, including the sub-study of patients who received an additional 3 months of treatment followed by a multi-detector computed tomography (MDCT) scan.
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... (613) 686-5745 Cerepotec Pharmalef
Amgen (Nasdaq: AMGN) announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate(TM) (romiplostim) in the European Union (EU). The CHMP recommends Nplate for adult chronic immune (idiopathic) thrombocytopenia purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Recent reports have brought attention to the Food and Drug Administration's (FDA's) plan to list those drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians, and patients. The
Six transalpine regions, representing five European countries, have just formalized the creation of the Alps Bio Cluster, a European cluster initiative that aims to unite research, industrial and training resources in the biotech and medtech sectors over an extended transalpine area.
Limdato, www.limdato.com knows that you will never see effective monitoring results unless you know the “red flag” issues in your trial. (613) 686-5745 Cerepotec Pharmalef
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.
ProPublica on Thursday examined a U.S. investigation into whether Indian pharmaceutical company Ranbaxy engaged in a "pattern of systemic fraudulent conduct" by concealing its drug manufacturing process violated FDA standards, including HIV/AIDS medications used in the
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.
Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to overcome, but the truth is that everybody working in this industry had to start somewhere and as the industry grows positions need to be filled. (613) 686-5745 Cerepotec Pharmalef
Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended suspension of the marketing authorisation for IONSYS(R) (fentanyl iontophoretic transdermal system), indicated for the management of acute moderate to severe post-operative pain for use in a hospital setting only.
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.
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
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.