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clinical trials india Welcome

 Welcome to Excel Life Sciences a  Clinical Trial Management Organization in India.

Your success. At Excel Life Sciences (ELS) that’s our commitment to you. To navigate today’s rapidly changing operating and regulatory environment, you need a partner with the experience necessary to understand your needs and help you achieve your goals. As the leading Trial Management Organization in India and through our trusted partnerships worldwide, we have the capabilities and bandwidth to take on any project large or small. And with offices and executive leadership based in the United States, you can be sure that we’re available when you are. Our extensive expertise comes from:

 
  • 125 years combined experience in Clinical Medicine, Pharmaceutical Medicine and Biometrics
  • 45 years of regulatory experience and top US and India senior regulatory executives on the ELS advisory board
  • 225 successfully conducted clinical trials at over 500 sites
  • 120 IND approvals and contribution to 20+ NDA approvals in US, Europe and Asia

 

 
clinical trials india What's New at ELS
  clinical trials india

Excel Life Sciences Continues Expansion Adding Two Seasoned Executive Team Members

ELS , a clinical trial management organization in India announces it has added 2 seasoned industry professionals—Dan McDonald as VP, Business Strategy and Heather Balcarcel as Director of Marketing-- to its Executive Leadership Team. These additions reflect ELS’ aggressive growth trends and plans for 2008 and beyond, as it supports a growing portfolio of clients in the United States and Europe and addresses strong demand from sponsors looking to expand their clinical trials into India.

Click Here to View Full Press Release.

 
Latest News

Eli Lilly and Company Agrees to Buy ImClone Systems Incorporated for $6.5 Billion

INDIANAPOLIS and NEW YORK, Oct 06, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Eli Lilly and Company (NYSE: LLY) and ImClone Systems Inc. (Nasdaq: IMCL) today announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion. The offer...

Biocryst Pharmaceuticals Cuts Staff by 20 Percent

BioCryst Pharmaceuticals Inc. trimmed its staff by 20 percent, including 17 jobs at its Birmingham headquarters.

Genetic Tests May Pinpoint Who Should Get Roche And Genentech, Inc.'s Avastin, Indiana University School of Medicine Study

LONDON (Reuters) - Genetic tests could in future show who will respond best to Genentech and Roche's blockbuster cancer drug Avastin -- a positive development for patients but not necessarily for sales.

Chondroitin Sulphate Linked To Lower Knee Swelling, Scientists At University of Utah School of Medicine And University of Maryland Say

Nutra Ingredients -- 03-Oct-2008 - Supplements of chondroitin sulphate may reduce swelling in the knee of osteoarthritis sufferers, according to new analysis of GAIT II.

Free Drug Samples Carry Risks For Children; First Of Its Kind Study Finds Safety Concerns In Frequently Distributed Samples, Study

EurekAlert! -- Cambridge, MA...Free prescription drug samples distributed to children may be unsafe, according to a study by physicians from Cambridge Health Alliance and Hasbro Children's Hospital. The national study, the first to look at free drug sample use among children, appears in the October 2008 issue of Pediatrics.

Roche Holding AG , Genentech, Inc. Says Two Drugs Don't Boost Lung Cancer Survival

ZURICH/LONDON, Oct 6 (Reuters) - Roche Holding AG and Genentech Inc said on Monday a study into the benefits of combining their Tarceva and Avastin drugs for lung cancer patients did not show an increase in overall survival.

Chemo Jab 'Can Cure Early Cancer', Medical Research Council Says

Telegraph -- The jab, of a chemotherapy drug already used to treat ovarian and lung cancer, could now replace the traditional three weeks of radiotherapy as the standard way to fight the disease.

Scientists Identify Gene Variant Involved In Isolated Cleft Lip, National Institutes of Health (NIH) Study

NIH -- About 20 percent of isolated cleft lip, one of the worlds most common birth defects, may be due to a one-letter difference in the DNA sequence of a gene involved in facial development, researchers supported by the National Institutes of Health report.

Inflammatory Bowel Gene Uncovered By German And UK Researchers; Nature Genetics Reports

BBC News -- Genetic variations which predispose people to a common inflammatory bowel condition have been uncovered by a team of German and UK researchers.

Urine Samples Could Reveal Breast Cancer Risk, Children's Hospital Boston Study

Medical News Today -- A few drops of urine may reveal whether a woman is at risk for breast cancer, researchers led by Marsha Moses, PhD, of the Vascular Biology Program at Children's Hospital Boston, have found. In tests, the urine of women with each of two types of breast cancer had markedly elevated levels of certain biomarkers that indicate increased angiogenesis -- known as MMP-9 and ADAM-12 ...

Newly Identified Cells Make Fat, Howard Hughes Medical Institute And Rockefeller University Study

Rockefeller University -- To understand where fat comes from, you have to start with a skinny mouse. By using such a creature, and observing the growth of fat after injections of different kinds of immature cells, Rockefeller University scientists have discovered an important fat precursor cell that may in time explain how changes in the numbers of fat cells might increase and lead to obesity. The...

Perrigo Company Acquires Mexican Manufacturer for $25 Million

ALLEGAN, Mich., Oct. 6 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) announced today that it has acquired Laboratorios Diba, S.A. for approximately $25 million in cash. Based in Guadalajara, Mexico, privately-held Laboratorios Diba is a store brand manufacturer of over-the-counter (OTC) and prescription pharmaceuticals, including antibiotics, hormonals and opthalmics. The acquisition...

Biolex Therapeutics Enters Into Agreement to Acquire Full Locteron(R) Commercial Rights; Will Pay up to $138 Million

PITTSBORO, NC--(MARKET WIRE)--Oct 6, 2008 -- Biolex Therapeutics, Inc. announced that it has entered into an agreement with OctoPlus N.V. to acquire OctoPlus' 50 percent share of commercial rights to the Locteron product candidate for hepatitis C. Under the agreement, Biolex will take full responsibility for development and commercialization of Locteron. OctoPlus will retain a royalty interest in the...

Galenea and Otsuka Pharmaceutical Co., Ltd. Extend & Expand Schizophrenia Research Collaboration Worth $75 Million

CAMBRIDGE, Mass. and TOKYO, Oct. 6 /PRNewswire/ -- Galenea Corp. and Otsuka Pharmaceutical Co., Ltd. announced today the extension and expansion of their research and development collaboration. The two companies have been working together since January 2005 to discover and develop novel therapies for schizophrenia and other central nervous system (CNS) diseases. The new agreement calls for a one year...

CombinatoRx, Incorporated Says Drug Fails Trial, Shares Slump

Oct 6 (Reuters) - CombinatoRx Inc said its lead drug candidate to treat knee osteoarthritis failed to meet the main goal of a mid-stage trial, sending its shares crashing 83 percent. The main goal of the trial was to test the efficacy of the drug, Synavive or CRx-102, in reducing pain while walking on a flat surface, compared with a dummy drug.

Indian Biotech Sector To Touch $5 Bn By 2010

Financial Express -- Indian biotechnology sector is expected to become a five billion-dollar (around Rs 23,400 crore) industry by 2010, says a report.

Dendreon Corporation's Provenge Cuts Death Risk, Shares Soar

SEATTLE, Oct. 6 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) announced today that it has completed the planned interim analysis of the Phase 3, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial designed to assess the safety and efficacy of the investigational active cellular immunotherapy...

Alpharma Inc. and King Pharmaceuticals??, Inc. Enter into Confidentiality Agreement

Oct 6 (Reuters) - Alpharma Inc, which rejected a takeover bid by King Pharmaceuticals Inc last month, announced that the parties had entered into a confidentiality agreement, indicating their willingness to negotiate on a price.

Salix Pharmaceuticals, Ltd. Says Rifaximin Demonstrates Highly Statistically Significant Results in Prevention of Hepatic Encephalopathy in Pivotal Phase 3 Study

RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP - News) today announced the successful completion and outcome of its pivotal Phase 3 trial to evaluate the efficacy, safety and tolerability of rifaximin in preventing hepatic encephalopathy, or HE. This study demonstrates that the protocol-specified, intent-to-treat, primary endpoint comparison of a 6-month course of rifaximin...

Variations In Key Genes Increase Caucasians??? Risk Of Heroin Addiction, Rockefeller University Study

Rockerfeller University -- Sometimes, small changes do add up. In the case of addictive diseases, tiny variations in a few genes can increase or decrease the likelihood of some people developing a dependency on heroin. Now, by examining a select group of genetic variants in more than 400 former severe heroin addicts, Rockefeller University researchers have identified several genetic variations in American...

Emory University Psychiatrist Did Not Report Drug Income

Pharmalot -- For several years, Charles Nemeroff assured Emory University, where he chaired the psychiatry department, that he wouldnt accept more than $10,000 in consulting fees from Glaxo, since he was the primary investigator on an NIH-funded grant for research into a Glaxo drug.

3 European Scientists Share Nobel Medicine Prize

STOCKHOLM, Sweden (AP) Three European scientists shared the 2008 Nobel Prize in medicine on Monday for separate discoveries of viruses that cause AIDS and cervical cancer, breakthroughs that helped doctors fight the deadly diseases.

Discovery Of Natural Compounds That Could Slow Blood Vessel Growth, Johns Hopkins University School of Medicine Study

ScienceDaily (Oct. 4, 2008) Using computer models and live cell experiments, biomedical engineers at the Johns Hopkins University School of Medicine have discovered more than 100 human protein fragments that can slow or stop the growth of cells that make up new blood vessels.

Form Of Crohn's Disease Traced To Disabled Gut Cells, Washington University School of Medicine Study

ScienceDaily (Oct. 5, 2008) Scientists report online in Nature that they have linked the health of specialized gut immune cells to a gene associated with Crohn's disease, an often debilitating and increasingly prevalent inflammatory bowel disorder.

Biolex Therapeutics Completes $60 Million Series D Financing to Accelerate Development of Locteron(R) in Hepatitis C

PITTSBORO, NC--(MARKET WIRE)--Oct 6, 2008 -- Biolex Therapeutics, Inc. announced the closing of a $60 million Series D financing led by Clarus Ventures, a leading biotechnology investor, with OrbiMed Advisors participating as a new investor. Existing investors participating in the financing included Intersouth Partners, Quaker BioVentures, Johnson & Johnson Development Corporation, Investor Growth...

Antisocial Behavior May Be Caused By Low Stress Hormone Levels, University of Cambridge Study

ScienceDaily (Oct. 5, 2008) A link between reduced levels of the 'stress hormone' cortisol and antisocial behaviour in male adolescents has been discovered by a research team at the University of Cambridge.

Pfizer Inc. , Boehringer Ingelheim Corporation's Spiriva Shows Little Aid to Long-Term Lung Function

BURLINGTON, ON, Oct. 5 /CNW/ - Results of the UPLIFT(R) trial(1), presented today at the European Respiratory Society (ERS) Annual Congress, demonstrated that when patients with Chronic Obstructive Pulmonary Disease (COPD) received tiotropium (SPIRIVA(R)), there was a statistically significant 16% decrease in the risk of death (p0.016). This is important new research because COPD is Canada's fourth...

Biocept, Inc. Announces CEO and Director Appointments

SAN DIEGO, Oct. 6 /PRNewswire/ -- Biocept, Inc. ("Biocept"), an emerging leader in biotechnology, announced today the appointment of Stephen M. Coutts, Ph.D. as CEO, President and Director and the appointment of Edward A. Dennis, Ph.D., as Director. Biocept also announced the resignation of its former CEO, President and Director, Gordon F. Janko.</p><p>"We are pleased to welcome Dr. Coutts, a highly...

DNA-based Vaccine Shows Promise Against Avian Flu, Rockefeller University Study

Rockefeller University -- Though it has fallen from the headlines, a global pandemic caused by bird flu still has the United States Centers for Disease Control and Prevention on high alert. Yet, to date, the only vaccines that have proven even semi-effective are produced in chicken eggs, take five to six months to prepare and act against a single variant of the H5N1 virus, which mutates incredibly...

Dr Reddy's Multi-Drug 'Polypill' Finally To Tackle Heart Problems, University of Auckland Will Begin Study

New Scientist -- Tests of a single, cheap tablet combining a range of drugs that protect against heart disease and stroke have begun.

Malaysia's Biotech Industry Expected To Grow 22 Percent Annually, Says PM

KUALA LUMPUR, Oct 6 (Bernama) -- Malaysia's biotech industry which is currently valued at RM1.3 billion is expected to grow 22 percent annually, driven largely by the development of oil palm, Prime Minister Datuk Seri Abdullah Ahmad Badawi said Monday.

Johnson & Johnson's Remicade Tops Azathioprine in Crohn's Disease Study

<p> ORLANDO, Fla., Oct. 6 /PRNewswire/ -- Data presented for the first time from the Phase 3b Study of Patients with Crohn's Disease Naive to Immunomodulators and Biologic Therapy (SONIC) may provide new insights into the approach to care of patients with moderate to severe Crohn's disease. According to findings from the SONIC trial, a significantly greater proportion of patients with moderate to...

Genentech, Inc. Says Raptiva Patient Develops Brain Disorder

GENEVA, Switzerland, October 2 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that Genentech Inc. has reported a case of progressive multifocal leukoencephalopathy (PML) in a 70-year old patient who had received Raptiva(R) (efalizumab) for more than four years of treatment of chronic plaque psoriasis. Genentech markets Raptiva(R) in the United States....

Genentech, Inc. , Glycart Biotechnology AG and Roche Enter into Collaboration Agreement; will Record $105 Million in R&D Expense

Genentech, Inc. (NYSE:DNA), GlycArt, a company wholly-owned by Roche, and Roche (SWX:ROG) have entered into a collaboration agreement, including a license from GlycArt to Genentech, for the joint development and commercialization of GlycArts GA101 molecule. The companies will be developing GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target...

New Class Of Drugs Might Cause Congenital Heart Defects; Lithium Therapy For Bipolar Disorder May Be Dangerous For Women Of Childbearing Age, Thomas Jefferson University Study

EurekAlert -- Individuals with bipolar disorder are usually treated with 'mood stabilizing' drugs, one of which is lithium an inhibitor of GSK-3 proteins. As new drugs that are more powerful inhibitors of GSK-3 are under development despite controversial studies suggesting a link between lithium therapy and congenital heart defects, Thomas Force and colleagues, at Thomas Jefferson University, Philadelphia...

Asthma Meds Don't Work As Well In Overweight Patients, Study

NEW YORK (Reuters Health) - Lab experiments indicate that people with asthma who are overweight or obese have a reduced response to steroid treatment, compared with their lean counterparts.

Court Affirms Amgen EPO Patents, Roche Loses Big Patent Case Brought By

THOUSAND OAKS, Calif. - (Business Wire) Amgen (NASDAQ:AMGN) announced today that the United States (U.S.) District Court in Boston issued its written decision upholding the prior jury verdict and court rulings regarding the infringement, validity and enforceability of 10 claims of four of Amgens erythropoietin (EPO) patents. The Court also ruled that Amgen is entitled to a permanent injunction prohibiting...

Children's National Medical Center and University of Iowa Researchers Develop Novel Anti-Tumor Vaccine

EurekAlert! -- WASHINGTON, DCA novel anti-tumor vaccine for neuroblastoma and melanoma developed by scientists and clinicians at Children's National Medical Center in collaboration with investigators from the University of Iowa is showing significant impact on tumor growth in mice, according to new research published in the October edition of the research journal Cancer Immunology, Immunotherapy...

York Pharma PLC Announces The Acquisition Of Leading Dermatological & Wound Care Brands; Company has Raised $51.2 Million to Finance the Product Acquisition and Support Future Operations

HITCHEN, England--(BUSINESS WIRE)--York Pharma Plc (AIM: YRK) announces the acquisition of the worldwide commercial rights to two leading skin care and wound healing products. At the same time the company has raised $51.2 million to finance the product acquisition and support future operations.</p><p>The acquisition will enable the York management team to leverage Yorks existing sales and marketing...

Eli Lilly and Company and Deciphera Pharmaceuticals Announce Licensing and Collaboration Agreement

INDIANAPOLIS, Ind. and LAWRENCE, Kan., Oct. 3 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY - News) and privately-held Deciphera Pharmaceuticals, LLC today announced that the two companies have entered into a collaboration and worldwide licensing agreement related to Deciphera's preclinical B-Raf kinase inhibitor program for the study of potential oncology therapeutics.</p><p>The collaboration...

Calorie Overload Sends The Brain Haywire, University of Wisconsin-Madison Research Team Discovers Brain Pathway Responsible For Obesity

EurekAlert -- University of Wisconsin-Madison researchers, for the first time, have found a messaging system in the brain that directly affects food intake and body weight. Reported in the Oct. 3, 2008 issue of Cell, the findings--from a study in mice--point to a completely new approach to treating and preventing obesity in humans. The discovery also offers hope for new ways to treat related disorders...

Crucell N.V. Wins Ebola, Marburg Contract, Shares Up

LEIDEN, NETHERLANDS--(MARKET WIRE)--Oct 3, 2008 -- Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced that it received a National Institutes of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) contract aimed at advancing the development of a multivalent filovirus vaccine that includes both Ebola and Marburg viruses. The contract...

University of California, Riverside Researchers Propose Minocycline As A Promising Drug For Patients With Fragile X Syndrome

EurekAlert -- A UC Riverside-led team of biomedical scientists has found that a readily available drug called minocycline, used widely to treat acne and skin infections, can be used to treat Fragile X syndrome, the most common inherited cause of mental impairment and the most common cause of autism.

Opko Health, Inc. Acquires Worldwide Ophthalmic Rights to Teva Pharmaceutical Industries Limited's Budesonide for Inflammatory and Allergic Ocular Conditions

MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (AMEX:OPK) today announced that it has acquired exclusive worldwide rights from Teva Pharmaceuticals Industries Ltd. (TEVA) to Tevas proprietary formulation of budesonide for the treatment of various inflammatory and allergic conditions of the eye. Tevas proprietary budesonide product is currently marketed in Italy under the tradename XAVIN for the treatment...

Anesiva, Inc. Secures Financing for Up to $30 Million

SOUTH SAN FRANCISCO, Calif., Oct. 2 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV - News), a specialty pharmaceutical company focused on pain management, announced that it has successfully secured a term loan for up to $30 million. The financing was led by Oxford Finance Corporation, and was co-funded by CIT Healthcare LLC and Compass Horizon Funding Company LLC. The first tranche of $20 million...

University of Toronto Researchers Reveal Epstein-Barr Virus Protein Contributes To Cancer

EurekAlert -- Researchers at the University of Toronto have shown that the EBNA1 protein of Epstein-Barr virus (EBV) disrupts structures in the nucleus of nasopharyngeal carcinoma (NPC) cells, thereby interfering with cellular processes that normally prevent cancer development. The study, published October 3rd in the open-access journal PLoS Pathogens, describes a novel mechanism by which viral proteins...

Liver Transplant Recipients Almost 3 Times More Likely To Develop Cancer, Finnish Study, Journal

EurekAlert! -- Cancer incidence is higher among liver transplant recipients in Finland compared to the general population, according to a new study in the October issue of Liver Transplantation, a journal by John Wiley & Sons. The article is also available online at Wiley Interscience (www.interscience.wiley.com).

Belgians Seize Two Million Counterfeit Drugs Destined For Africa

BBC -- More than two million counterfeit drugs destined for Africa have been seized in Belgium, customs officials say. They said the shipment from India, including copies of an anti-malaria drug, was the biggest seizure of fake medication ever made in Europe.

EU Says Zentiva, Sanofi-Aventis (France) Deal Notification Incomplete

BRUSSELS, Oct 3 (Reuters) - The notification to EU competition regulators of plans by French pharmaceuticals producer Sanofi-Aventis to buy Czech generic drugmaker Zentiva is incomplete, the European Commission said.

DNA Of Good Bacteria Drives Intestinal Response To Infection, National Institute of Allergy And Infectious Diseases (NIAID) Study

NIH -- A new study shows that the DNA of so-called "good bacteria" that normally live in the intestines may help defend the body against infection.

Millisecond Brain Signals Predict Response To Fast-Acting Antidepressant, National Institutes of Health (NIH) Study

NIH -- Images of the brains fastest signals reveal an electromagnetic marker that predicts a patients response to a fast-acting antidepressant, researchers have discovered.

BioMS Medical's Phase III U.S. Multiple Sclerosis Trial Receives Positive Safety Review from Data Safety Monitoring Board

EDMONTON, Oct. 3 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS - News), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's U.S. pivotal phase III MAESTRO-03 trial of dirucotide (MBP8298) in patients with secondary progressive MS has completed a safety analysis and recommended that the trial...

Olfactory Bulb Glial Cell Transplant Preserves Muscles In Paraplegic Rats, and Study

ScienceDaily (Oct. 3, 2008) Researchers from the Centro de Biologa Molecular Severo Ochoa (CSIC-UAM), Crdoba University and the Instituto de Biomedicina de Valencia (CSIC) have analysed the degree of preservation in the skeletal muscles of paraplegic rats treated with a transplant of Olfactory bulb glial cells (OBG).

Ferro Corporation Announces Agreement to Sell Fine Chemical Business for $66 Million in Cash

CLEVELAND--(BUSINESS WIRE)--Ferro Corporation (NYSE: FOE) announced today that it has signed an asset purchase agreement with Novolyte Technologies LP, an affiliate of Arsenal Capital Management LP, to sell its Fine Chemicals business for $66 million in cash.</p><p>This sale is consistent with our vision of focusing Ferros businesses around our core capabilities of particle engineering, formulation...

Elan Corporation PLC Unit Sale Delayed by Credit Crisis Says Sources

LONDON/NEW YORK, Oct 3 (Reuters) - Plans by Ireland's Elan Corp to sell its drug delivery unit in an auction have been delayed by the credit crisis but some discussions are still continuing, people familiar with the situation said.

Chromium Picolinate May Boost Satiety, Reduce Hunger, Pennington Biomedical Research Center And University of Florida Study

Nutra Ingredients -- 02-Oct-2008 - Daily supplements of chromium picolinate may reduce food intakes, hunger levels, and cravings for fat, according to a new study from the US.

French Scientists Close To Cracking Wheat's Genetic Code, Study

LONDON (Reuters) - Scientists believe they have found a way to map the hugely complex genetic code of wheat, the staple food for 35 percent of the world's population.

Eli Lilly and Company in Late Talks to Buy ImClone Systems Incorporated for $6.1 Billion

PHILADELPHIA, Oct 1 (Reuters) - ImClone Systems Inc in talks to be acquired by Eli Lilly and Co, sources familiar with the situation said on Wednesday, after ImClone had rebuffed a sweetened takeover offer from Bristol-Myers Squibb Co.

FDA Urged To Recall Cold Medicines For Children

AP -- With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.

Sanofi-Aventis (France) Set to Cut 800 Posts in France Says

PARIS, Oct 1 (Reuters) - French drugmaker Sanofi-Aventis is set to announce around 800 job cuts in France on Thursday, the CFDT trade union said.

Pfizer Inc. Drug Maraviroc Helps Advanced HIV At 48-Week Mark

BOSTON (Reuters) - The Pfizer Inc. AIDS drug maraviroc helps thwart the HIV virus in nearly half of people who have developed resistance to other treatments, according to two related studies published on Wednesday.

Radioactive Scorpion Venom Could Be Used To Fight Brain Cancer, University of Chicago Study; Dosing Began In TransMolecular, Inc.'s Phase 1/2 Clinical Trial Of 131I-TM601

Telegraph -- Radioactive scorpion venom sounds like the ultimate poison but it is now being tested as a treatment for malignant brain cancer. Scientists have discovered that a non-toxic extract from the venom seeks out and locks onto malignant cells after it is injected into the body.

Maryland Stem Cell Commission Warns Of Funding Cuts As It Seeks Research Applications

Baltimore Business Journal -- The state is now seeking applications for stem cell research grants but officials warned the $19 million fund could shrink in the coming weeks.</p><p>The states stem cell fund could be a target for cuts as Gov. Martin OMalley prepares to make budget reductions at the Board of Public Works Oct. 15 meeting, according to the Maryland Stem Cell Commission. Waning...

Merck & Co., Inc. Discontinues Development of Investigational Medicine Taranabant for Obesity

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. will not seek regulatory approval for taranabant, an investigational medicine, to treat obesity and is discontinuing its Phase III clinical development program for taranabant for obesity.</p><p>"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the...

FDA Approves Use of Bristol-Myers Squibb Company's REYATAZ(R) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

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

Specific Gene Found In Adolescent Men With Delinquent Peers, Study

FSU -- Birds of a feather flock together, according to the old adage, and adolescent males who possess a certain type of variation in a specific gene are more likely to flock to delinquent peers, according to a landmark study led by Florida State University criminologist Kevin M. Beaver.

Analogue Or Human Insulins OK For Type 2 Diabetes, Study

NEW YORK (Reuters Health) - People with type 2 diabetes who need insulin to control their blood glucose levels can choose either human insulin or a structurally similar synthetic version to do the job, a study shows.

The Dietary Supplement Genistein Can Undermine Breast Cancer Treatment, University of Illinois Virginia State University and the National Center for Toxicological Research Study

UIUC -- Women taking aromatase inhibitors to treat breast cancer or prevent its recurrence should think twice before also taking a soy-based dietary supplement, researchers report. Genistein, a soy isoflavone that mimics the effects of estrogen in the body, can negate the effectiveness of aromatase inhibitors, which are designed to reduce the levels of estrogens that can promote tumor growth in some...

News Media Often Do Not Report Potential Sources Of Bias In Medical Research, JAMA Reports

ScienceDaily (Oct. 2, 2008) An analysis of news media coverage of medical studies indicates that news articles often fail to report pharmaceutical company funding and frequently refer to medications by their brand names, both potential sources of bias, according to a study in the October 1 issue of JAMA.

New Way To Make Malaria Medicine Also First Step In Finding New Antibiotics, University of Illinois Study

ScienceDaily (Oct. 1, 2008) University of Illinois microbiology professor William Metcalf and his collaborators have developed a way to mass-produce an antimalarial compound, potentially making the treatment of malaria less expensive.

Groundbreaking Discovery May Lead To Stronger Antibiotics; University of Virginia Researchers Establish Landmark Technique to Decode Proteins in Cells

UVA -- The last decade has seen a dramatic decline in the effectiveness of antibiotics, resulting in a mounting public health crisis across the world. A new breakthrough by University of Virginia researchers provides physicians and patients a potential new approach toward the creation of less resistant and more effective antibiotics.

GenVec Inc. Receives Third-Year Funding from National Institute of Allergy And Infectious Diseases (NIAID) for HIV Vaccine Contract Valued Up to $52 Million

GAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq:GNVC) announced today that the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), has executed its second option period (year three) under a previously announced, five-year contract with GenVec valued at up to $52 million for the production of HIV vaccines. GenVec will receive up to...

GlaxoSmithKline Settles U.S. Paxil Lawsuit for $40 Million

LONDON, Oct 2 (Reuters) - GlaxoSmithKline has agreed to settle a long-standing U.S. case over its antidepressant Paxil by paying insurers $40 million to reimburse health plans that paid for children and adolescents to receive the drug.

'Hub' Of Fear Memory Formation Identified In Brain Cells, Emory University School of Medicine Study

Emory Univ. -- A protein required for the earliest steps in embryonic development also plays a key role in solidifying fear memories in the brains of adult animals, scientists have revealed. An apparent hub for changes in the connections between brain cells, beta-catenin could be a potential target for drugs to enhance or interfere with memory formation.

Spurring Medical Innovation, Help FDA Meet 21st Century Challenges And Advance Patient Access To Safer And More Effective Drugs And Medical Devices

Medical News Today -- Today, October 1, 2008, the Manhattan Institute's Center for Medical Progress announces the launch of Project FDA. Project FDA is an initiative designed to help the Food and Drug Administration develop the 21st Century technologies and regulations that can accelerate medical innovation, and get safer and more effective treatments to patients faster, cheaper, and smarter than is...

Bones May Weaken After Weight Loss Surgery, Columbia University Study

NEW YORK (Reuters Health) - Patients lose bone density after weight loss surgery, and the more weight they lose, the greater the drop, new research shows.

National Cancer Institute Launches First-Ever Study To Determine If Biomarkers Can Help Guide Treatment For Lung Cancer

NCI-- Today, a large national clinical trial for non-small cell lung cancer was launched to validate whether a biomarker can predict clinical benefit in the treatment of this disease. Biomarkers, which are molecules found in the body that can signal an abnormal process or disease, would identify a target known as epidermal growth factor receptor (EGFR). This receptor can be increased in some lung cancers...

Intradigm Corporation Raises $18.5 Million in Series B Financing

PALO ALTO, Calif., Oct. 2 /PRNewswire/ -- Intradigm Corporation, a leading developer of targeted, systemic RNA interference (RNAi) therapeutics, today announced that the company raised $18.5 million in a Series B financing. The financing was led by Lilly Ventures with participation from other new investors, Roche Venture Fund and MP Healthcare Venture Management. Existing investors, Frazier Healthcare...

Kids Who Wheeze With Rhinovirus at Higher Asthma Risk; But Study Can't Say Whether Germs Cause Condition Or Just Identify Those Who May Get It, University of Wisconsin Study

THURSDAY, Oct. 2 (HealthDay News) -- Young children who wheeze when they have rhinovirus infection -- the most common cause of colds -- are at much greater risk of developing asthma later during childhood, a new study says.

Frozen Liver Raises Hopes Of Organ 'Bank', Researchers From Say

New Scientist -- A "BANK" of donated organs ready for use is one step closer thanks to the successful freezing, thawing and transplantation of a pig's liver. If human livers, which are about the same size, can survive this process, more people in need of transplants could receive them.

Celldex Therapeutics, Inc. Receives $10 Million Milestone Payment

NEEDHAM, Mass.--(BUSINESS WIRE)--Celldex Therapeutics, Inc. (NASDAQ: CLDX - News) today announced that it has received a milestone payment of $10,000,000 from an affiliate of Paul Capital Healthcare (PCH). The payment was triggered by the market launch of Rotarix in the United States. Rotarix is marketed worldwide by GlaxoSmithKline (GSK).</p><p>We are thrilled that GSK has successfully launched...

VWR International, Inc. Acquires OmniLab Biosystems AG

WEST CHESTER, Pa.--(BUSINESS WIRE)--VWR International, LLC, a leading global laboratory supply company, announced today that it has acquired OMNILAB AG, a Swiss scientific laboratory supply distributor headquartered in Mettmenstetten near Zurich.</p><p>OMNILAB was founded in 1990 and is one of Switzerlands largest independent suppliers of laboratory equipment and consumables. OMNILAB is recognized...

MedWatch: Medtronic, Inc. Neuromodulation INDURA One-Piece Intrathecal Catheters

FDA announces class 1 recall: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. Read more from the <a href"http://www.fda.gov/cdrh/recalls/recall-062608.html" target"_blank"><b>FDA</b></a>.

First in Nation: Judges Say Can Charge Employers for Its Health Plan

NYT -- In a decision that could set the stage for a test of the supremacy of a longstanding federal labor law, a panel of federal judges found Tuesday that San Francisco had the right to charge employers to help pay for its universal health care plan, the first in the nation.

GlaxoSmithKline May Shed 6% of R&D Staff to Save Costs

LONDON, Sept 30 (Reuters) - GlaxoSmithKline said on Tuesday it was planning to cut up to 850 research and development jobs in Britain and the United States, in a bid to improve productivity.

Idera Pharmaceuticals, Inc. Drug IMO-2055 Disappoints as Kidney Cancer Treatment

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced preliminary data from the first part of a Phase 2 clinical study conducted by the Company of IMO-2055 monotherapy in patients with metastatic or recurrent clear cell renal carcinoma (RCC). The primary objective was not achieved in the study. The primary objective was tumor response based on RECIST (Response...

Gene Could Link Obesity, Colon Cancer, University of Alabama at Birmingham Study

MedPage -- BIRMINGHAM, Ala., Sept. 30 -- The risk of colorectal cancer may be reduced by the presence of a genetic variation that also lowers adiponectin hormone secretion by fat cells, researchers found.

Sanofi-Aventis (France), Daiichi Sankyo Co Ltd. Delay Japan's First Imported Vaccine

Sept. 30 (Bloomberg) -- Sanofi-Aventis SA and Daiichi Sankyo Co. delayed plans to sell the first imported vaccine in Japan because it's taking longer than expected to make the product meet the country's standards.

Large Doses Of Vitamin C Supplements May Reduce The Effectiveness Of Cancer Drugs, Memorial Sloan-Kettering Cancer Center Researchers Have Warned

Medical News Today -- Experiments on lab cultured cells and mice suggested that high amounts of vitamin C derivative at the cellular level, as results from taking supplements, may actually reduce the effect of anti-cancer drugs by helping the cancer cells live longer.

Faulty Gene "Is Link To Dyslexia," Oxford University Study

LONDON (Reuters) - The common genetic variation linked to dyslexia may also help explain why some people without the learning difficulty are not good readers, researchers said on Wednesday.

New $30M California Institute To Focus On AIDS Vaccine; The Scripps Research Institute and International AIDS Vaccine Initiative Joint Venture

WASHINGTON (Reuters) - A new AIDS vaccine research center dedicated to solving one of the stickiest problems holding back development of such a vaccine will open in California, researchers announced on Tuesday.

New Genes Linked To Gout, National Heart, Lung, and Blood Institute Study

EurekAlert -- Researchers have identified two new genes and confirmed the role of a third gene associated with increased risk of higher levels of uric acid in the blood, which can lead to gout, a common, painful form of arthritis. Combined, the three genetic variations were associated with up to a 40-fold increased risk in developing gout. The findings suggest that genetic testing could one day...

Asian-White Couples Face Distinct Pregnancy Risks, Stanford University School of Medicine and Study

STANFORD, Calif. - Pregnant women who are part of an Asian-white couple face an increased risk of gestational diabetes as compared with couples in which both partners are white, according to a new study from Lucile Packard Children's Hospital and the Stanford University School of Medicine.

MediGene AG Spins Out mTCR Program - Independent Company Founded

Martinsried/Munich, October 1, 2008. MediGene AG (Frankfurt, Prime Standard: MDG) and three private investors have founded Immunocore Ltd, which will focus on the technology platform for monoclonal T-cell receptors (mTCR) of MediGene's UK subsidiary MediGene Ltd. MediGene holds a 38.5% stake in Immunocore Ltd and will be the largest shareholder of the new company. </p><p> The further development...

Hormone Therapy Doesn't Raise Heart Risk in Study

WASHINGTON (Reuters) - Women who take hormone replacement therapy to treat menopause symptoms do not have a higher than usual risk of heart attack, especially if they use a cream or skin patch or take "cyclic" hormone combinations, Danish researchers reported on Tuesday.

Genes Influence Effectiveness Of Weight-Loss Drug; Patients With Specific Genetic Make-Up Experienced Increased Weight Loss With Sibutramine, Mayo Clinic Study

Bethesda, MD (Oct. 1, 2008) Obese patients with a specific genetic make-up lose more weight when taking the weight loss drug sibutramine and undergoing behavioral therapy compared to those without this genetic make-up, reports a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

Fewer Doses Of Anthrax Vaccine Protect Just As Well, Centers for Disease Control and Prevention (CDC) Study

WASHINGTON, Sept 30 (Reuters) - Giving fewer doses of the anthrax vaccine protects a person just as well from the bacteria that causes the disease, which could extend limited supplies of the shots, researchers said on Tuesday.

Antisocial Behavior Hormone Link; "Fight Or Flight" Hormone Limits Aggression, University of Cambridge Study

LONDON (Reuters) - Stress hormone cortisol, involved in our "fight or flight" response, may also limit aggressive antisocial behavior, British researchers said on Wednesday.

Advanced Life Sciences Holdings, Inc., Wyeth Unit in Pact for Pneumonia Drug

Oct 1 (Reuters) - Advanced Life Sciences Holdings Inc said a unit of Wyeth bought a 4.9 percent stake in the biopharmaceutical company as part of an agreement related to antibiotic cethromycin, sending its shares up 36 percent.

OXiGENE Announces Strategic Collaboration With to Fund Up to $40 Million to Advance Pipeline

WALTHAM, Mass., Oct. 1, 2008 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, has entered into a strategic collaboration with Symphony Capital Partners, L.P. (Symphony) that will provide OXiGENE with up to $40 million to further advance its pipeline of vascular disrupting agent...

Emergent BioSolutions Wins $404M Anthrax Vaccine Award

Emergent Biosolutions Inc. has won a contract to provide more anthrax vaccine to the U.S. government worth as much as $404 million.

Ironwood Raises $50 Million to Advance Linaclotide Through Phase 3

<p> CAMBRIDGE, Mass., Oct. 1 /PRNewswire/ -- Ironwood Pharmaceuticals, Inc. today announced it has raised $50 million in a private equity financing. This capital will be utilized to support the ongoing Phase 3 development program evaluating linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC), to invest in a growing pipeline of internally...

VGX Pharmaceuticals (Formerly Known as Viral Genomix, Inc.) Awarded $23.5 Million National Institutes of Health (NIH) Contract to Develop DNA-Based Preventive HIV Vaccine Delivered Via Electroporation

U.S. Government Grant Supports Preclinical and Clinical Development, Manufacturing and Other Activities for VGXs HIV DNA Vaccine Candidate</p><p>BLUE BELL, Pa.--(BUSINESS WIRE)--VGX Pharmaceuticals (VGX), a developer of DNA vaccines against cancer and infectious diseases that has entered into a definitive merger agreement with Inovio Biomedical (AMEX:INO), announced today that the National Institute...

Solvay Pharmaceuticals, Inc. Scratches Plan for $300 Million Birmingham Plant

Solvay Pharmaceuticals Inc. has scrapped plans to build a $300 million flu drug plant which Birmingham Mayor Larry Langford said was destined for the city.

Novel Mechanism For Regulation Of Gene Expression Identified, Stowers Institute for Medical Research Study

ScienceDaily (Oct. 1, 2008) The Stowers Institutes Conaway Lab has demonstrated that an enzyme called Uch37 is kept in check when it is part of a human chromatin remodeling complex, INO80. The results were published in the September 26 issue of Molecular Cell.

FDA to Spend $2.5 Billion on Technology Upgrade

The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years. The contract is the cornerstone of the FDAs Information Technology for the 21st Century (ICT21) bioinformatics initiative, an extensive IT modernization program encompassing data...

Researchers At University of Oklahoma Health Sciences Center Create First Model For Retina Receptors

EurekAlert! -- A team of scientists at the University of Oklahoma Health Sciences Center has created the first genetic research model for a microscopic part of the eye that when missing causes blindness. The research appears in a recent issue of the Journal of Biological Chemistry.

Inotek Pharmaceuticals Corporation Appoints as President and CEO

- Addition of former Bausch & Lomb and Merck Executive completes transformation of management team -</p><p>BEVERLY, Mass.--(BUSINESS WIRE)--Inotek Pharmaceuticals Corporation announced today that it has hired Paul G. Howes as President, CEO and Director. Mr. Howes brings more than twenty years of senior level pharmaceutical experience to Inotek, most recently serving as President of the Americas...

Run Out Of Pain Killers Again? New System To Provide Detailed Tracking For Pharmaceuticals --

ScienceDaily (Sep. 30, 2008) Research scientists at SINTEF have developed a control dashboard for the pharmaceuticals industry. This enables all pharmacies, wholesalers and manufacturers to check where products are in the supply chain, availability, what stocks the neighbouring pharmacy has and the future prognoses.

Sanofi-Aventis (France) Loses Again in Bid to Keep Generic Plavix Off German Market

Sanofi-Aventis and partner Bristol-Myers Squibb have sufferd a new setback in their bid to reduce the damage caused by the sale in Germany of a generic version of their blockbuster blood thinner Plavix.

Bayer HealthCare Wins European Approval for Xarelto Pill

FRANKFURT, Oct 1 (Reuters) - Bayer's blood thinning pill Xarelto has been approved by the European Commission for the prevention of blood clots after hip or knee replacement surgery, the German drugmaker said on Wednesday.

BioPharm Executive: There Goes Wall Street

<img src"http://www.biospace.com/images/enewsletters/images_BE/pic_karl.jpg" width"100" height"123" hspace"5" vspace"3" align"left" /><b>There Goes Wall Street</b><br><br>It's difficult to even think about the life sciences industry these days...many of us have one eye glued to <b>CSPAN</b> and the other to our dwindling 401(k) accounts. Drug company execs that recently toured Congressional...

Blood Thinning Drug Warfarin Linked To Increased Bleeding In Brain, University of Cincinnati Study

ScienceDaily (Sep. 29, 2008) A new study shows that people who take the commonly used blood thinning drug warfarin may have larger amounts of bleeding in the brain and increased risk of death if they suffer a hemorrhagic stroke.

Pfizer Inc. Halts Heart Disease, Obesity Research; Focuses on Cancer

Sept. 30 (Bloomberg) -- Pfizer Inc., the world's largest drugmaker, is ending early-stage development of treatments for a range of illnesses from obesity to heart disease, to focus on more profitable diseases.

Popular COPD Treatment Increases Risk For Cardiac Events, Cardiac Death, Wake Forest University School of Medicine And Study

ScienceDaily (Sep. 29, 2008) New research out of Wake Forest University School of Medicine shows that use of the most commonly prescribed once-a-day treatment for chronic obstructive pulmonary disease (COPD) for longer than one month increases the risk of cardiovascular death, heart attack or stroke by more than 50 percent.

Dietary Supplements Glucosamine and/or Chondroitin Fare No Better than Placebo in Slowing Structural Damage of Knee Osteoarthritis, University of Utah School of Medicine and National Institutes of Health (NIH) Study

NIH -- The dietary supplements glucosamine and chondroitin sulfate, together or alone, appeared to fare no better than placebo in slowing loss of cartilage in osteoarthritis of the knee, researchers from the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) team report in the October issue of Arthritis & Rheumatism.[1] Interpreting the study results is complicated, however, because participants...

A.P. Pharma, Inc. Drug Fails to Meet Superiority Goal

REDWOOD CITY, Calif.--(BUSINESS WIRE)--A.P. Pharma, Inc. (NASDAQ:APPA - News), a specialty pharmaceutical company, announced today positive results from its pivotal Phase 3 study comparing the efficacy of APF530 (the Companys proprietary, sustained release formulation of granisetron) with Aloxi for the prevention of chemotherapy induced nausea and vomiting (CINV). Patients in the study were classified...

Ambrilia Biopharma Inc. Prioritizes its Divestment Strategy and Takes Cost-Cutting Actions to Extend Cash; Reduces Headcount By 33%

MONTREAL, QUEBEC--(Marketwire - September 29, 2008) - Ambrilia Biopharma Inc. (TSX: AMB) today announced that it has elected to prioritize its divestment strategy of monetizing (selling or licensing) its clinical assets C2L and goserelin before year-end along with cost-cutting actions which result in a hold on its antiviral R&D activities, significant reduction in cash consumption and a 33% decrease...

California Governor Schwarzenegger Vetoes Stem Cell Bill

SF Business Times -- Gov. Arnold Schwarzenegger vetoed SB 1565, aimed at making stem cell therapies and diagnostics funded by Californias multibillion-dollar stem cell research agency affordable and accessible.</p><p>The bill also would have made it easier for the California Institute for Regenerative Medicine to fund research beyond politically charged embryonic stem cells.</p><p>In vetoing...

Statins Don't Increase "Lou Gehrig's" Risk, FDA Reports

MedPage -- A new analysis by the US Food and Drug Administration (FDA) of data from over 40 clinical trials did not show a link between statins, drugs used to lower cholesterol, and higher risk of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease". The FDA said there is no need to change prescribing practice.

Birth Size Is A Marker Of Susceptibility To Breast Cancer Later In Life, London School of Hygiene and Tropical Medicine Study

EurekAlert -- Birth size, and in particular birth length, correlates with subsequent risk of breast cancer in adulthood, according to a new study published in PLoS Medicine by researchers at the London School of Hygiene and Tropical Medicine.

Q-Med AB Terminates Collaboration With Medy-Tox Inc.

Q-Med AB and Medy-Tox Inc., a pharmaceuticals company based in South Korea, have together decided to terminate the collaboration that the parties entered into during 2007. The collaboration comprised the development and commercialization of new products based on botulium toxin and potential for Q-Med to distribute Medy-Toxs existing botulinum toxin type A product.</p><p>The parties have both signed...

Hepatitis B Vaccine Not Associated with Multiple Sclerosis, Study

PARIS, Sept. 26 -- Hepatitis B vaccine generally does not increase the risk of multiple sclerosis or other conditions involving central nervous system inflammatory demyelination, although one brand seems to, a case-control study showed.

Common Gene Mutation Lowers Risk for Bipolar Disorder, University of Edinburgh Study

MONDAY, Sept. 29 (HealthDay News) -- New research suggests that a missing section of DNA in a certain gene may hold the key to whether a person does or does not develop bipolar disorder.

Advinus Therapeutics (P) Ltd. And Ortho-McNeil-Janssen Pharmaceuticals, Inc. Establish Drug Discovery And Development Collaboration; To Receive Milestone Payments Up To US $247 Million

BANGALORE, India--(BUSINESS WIRE)--Advinus Therapeutics (P) Ltd., a TATA Enterprise has announced a drug discovery and development collaboration with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI).</p><p>Under the agreement, Advinus and OMJPI have agreed to develop drug candidates for various disease targets. Advinus will be responsible for drug discovery and early clinical development (until...

Upcoming Events

FDA News and Rx Trials Institute’s:
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Sep 23-25
Philadelphia, PA

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Oct 22
Webinar
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Nov 11
Boston, MA


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General Information regarding regulatory requirements in India

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The CTRI is an online register of clinical trials being conducted in India.

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The Indian Council of Medical Research (ICMR), New Delhi is the apex body in India for the formulation, coordination and promotion of biomedical research.


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