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REGISTRATION OF CLINICAL TRIALS IN CTRI CAN BE ONLY DONE PROSPECTIVELY FROM 1ST APRIL 2018

clinical research CLINICAL TRIAL CTRI Drugs Controller General of India (DCGI) INDIA Indian Council of Medical Research (ICMR) REGISTRATION OF CLINICAL TRIALS IN INDIA

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INTERNATIONAL RESEARCH FUNDERS AND NGOS PLANS TO IMPLEMENT WHO STANDARD IN REPORTING CLINICAL RESEARCH RESULTS.

Coalition for Epidemic Preparedness Innovations ICMR Institut Pasteur Médecins Sans Frontières and Epicentre Norwegian Research Council PATH UK Medical Research Council WHO

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GLEN MARK RECIEVES USFDA CLEARENCE FOR CONDUCTING CLINICAL TRIAL FOR ANTI MYLOMMA DRUGS.

Anti myeloma CLINICAL TRIAL GBR 1342 Glenmark USFDA

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ONTARIO VETERINARY COLLEGE CANCER STUDY ON ANIMALS LEADS TO HUMAN CLINICAL TRIALS

booster vaccine Byram Bridle oncolytic virus Ontario Veterinary College OVC University of Guelph

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Weight-management drug Saxenda gets approval from FDA

January 02, 2015

FDA glucagon-like peptide-1 liraglutide Novo Nordisk obesity overweight Saxenda The U.S. Food and Drug Administration Victoza Weight-management drug

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Clinical Trial for Ebola vaccine approved by China

December 28, 2014

China Ebola virus Xinhua news agency

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FDA APPROVES GENETIC TEST TO HELP SOME COLON CANCER PATIENTS, PHYSICIANS CONSIDERING ERBITUX THERAPY

Bristol-Myers Squib cetuximab colorectal cancer CRC Eli Lilly and Company Erbitux gene mutation.epidermal growth factor receptor (EGFR) QIAGEN Manchester Ltd therascreen KRAS RGQ PCR Kit

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FDA APPROVES ZELBORAF AND COMPANION DIAGNOSTIC TEST FOR LATE-STAGE SKIN CANCER

August 23, 2011

BRAF V600E cobas 4800 BRAF V600 Mutation Test dacarbazine skin cancer Zelboraf (vemurafenib)

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ADCETRIS TO TREAT TWO TYPES OF LYMPHOMA

August 23, 2011

Adcetris CD30 FDA Hodgkin lymphoma (HL) lymphoma cells NATIONAL CANCER INSTITUTE systemic anaplastic large cell lymphoma (ALCL)

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FDA ISSUES NEW GUIDELINES TO IMPROVE QUALITY OF CLINICAL TRIAL

August 21, 2011

FDA New guidelines

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CARDIAC MYOSIN ACTIVATORS: A NEW CLASS OF DRUGS FOR HEART FAILURE TREATMENT

August 21, 2011

cardiac myosin activators heart failure treatment myosin Omecamtiv mercabil

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PFIZER CONDUCTS FIRST “VIRTUAL” CLINICAL TRIAL

August 06, 2011

FDA OAB Treatment Experience – REMOTE overactive bladder PFIZER PFIZER CONDUCTS FIRST VIRTUAL CLINICAL TRIAL

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RECENT MEDICAL DEVICE RECALLS BY FDA

FDA MEDICAL DEVICES

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ROLE OF SITE MANAGEMENT ORGANIZATION FOR CONDUCTING TRIALS IN INDIA

India promises to be one of the hottest destinations for conducting global clinical research owing to a large number of hospitals, experienced doctors, huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings. But even now India shares only a small market of clinical research when compared to the current global opportunity. As India is becoming a promising destination for many pharma and biotech based company, it is expected that the clinical trials conducted in India also will grow to several folds. The main attraction of global pharma companies to start their function in India is reduced cost to conduct clinical trials, when compared to the other part of the world. So to attract more companies to conduct trials in India we should also take in to consideration of conducting clinical trials in a cost effective manner. Here comes the important of Site Management Organization (SMO) for conducting clinical trials in India.

FDA APPROVES GENETIC TEST TO HELP SOME COLON CANCER PATIENTS, PHYSICIANS CONSIDERING ERBITUX THERAPY

The U.S. Food and Drug Administration have approved the first genetic test that can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the absence of a gene mutation. The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in patients whose CRC has spread to other parts of their body (metastasized). Studies have found that Eribitux is not effective in those who have the mutation.

ADCETRIS TO TREAT TWO TYPES OF LYMPHOMA

The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient’s own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

ONTARIO VETERINARY COLLEGE CANCER STUDY ON ANIMALS LEADS TO HUMAN CLINICAL TRIALS

Prof. Byram Bridle, University of Guelph Credit: University of Guelph A breakthrough in a cancer study in animals conducted by Ontario Veterinary College (OVC) at the University of Guelph will transform the the cancer therapy in humans.The findings in study conducted by the researchers in mice and in other animals such as cats are paving way for human clinical trials for various types of cancer. They have found that injecting oncolytic viruses (viruses that target cancer cells) intravenously into the spleen allows immune responses to be boosted much more rapidly and to much higher magnitudes than traditional vaccine methods. Typically, physicians need to wait weeks or months to administer a booster vaccine, with the down time potentially deadly.

CARDIAC MYOSIN ACTIVATORS: A NEW CLASS OF DRUGS FOR HEART FAILURE TREATMENT

University of Hull have designed a new class of drug for heart failure treatment which has shown positive results during phase II of the clinical trial conducted by the university. Omecamtiv mercabil is the first in a new class of drugs called cardiac myosin activators, which work in a different way to existing heart failure therapies.Rather than making the heart beat more often, the drug makes the heart muscles contract for longer, thereby increasing the volume of blood pumped with each stroke.It does this by extending the interaction between the proteins that cause muscle contraction, myosin and actin, thereby prolonging the contraction of the heart's left ventricle.

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