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CLINICAL TRIAL UPDATES

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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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FDA APPROVES GADAVIST AS IMAGING AGENT FOR CENTRAL NERVOUS SYSTEM SCANS

FDA GADAVIST GADOBUTROL GADOLINIUM BASED CONTARST AGENT MRI

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SAREUM REPORT POSITIVE TESTS ON CANCER DRUGS

CANCER DRUG DISCOVERY Chk1 INHIBITOR GEMCITABINE SAREUM

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FDA APPROVES NEW DRUG TO TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE

COPD EMPHYSEMA FDA FLARE-UPS ROFLUMILAST

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FDA APPROVES EDARBI TO TREAT HIGH BLOOD PRESSURE

BENICAR DIOVAN EDARBI FDA HIGH BLOOD PRESSURE OLMERSARTAN VALSARTAN

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BOTOX EFFECTIVE IN VAGINAL SPASM

February 27, 2011

acute vaginismus BOTOX botulinum Toxin A FDA VAGINAL SPASM

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INDIA HIV VACCINE UNDERGOES FIRST PHASE OF CLINICAL TRIAL

February 24, 2011

CLINICAL TRIAL INDIA HIV VACCINE.FIRST PHASE National AIDS Research Institute (NARI) tgAAC09

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IMMUPHARMA UPDATES ON CANCER COMPOUND PHASE I/IIA CLINICAL TRIAL

February 22, 2011

glioblastoma IMMUPHARMA pancreatic cancer PROSTATE CANCER

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JOHNSON & JOHNSON UNIT RECALLS 70,000 SYRINGES OF ANTIPSYCHOTIC DRUG INVEGA DUE TO CRACKS

February 22, 2011

antipsychotic Invega Sustenna Johnson & Johnson schizophrenia

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ANTIPSYCHOTIC DRUG LABELS UPDATED ON USE DURING PREGNANCY AND RISK OF ABNORMAL MUSCLE MOVEMENTS AND WITHDRAWAL SYMPTOMS IN NEWBORNS

February 22, 2011

Abilify and Invega ANTIPSYCHOTIC DRUG Clozaril FDA Geodon Haldol Risperdal Seroquel Zyprexa

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FDA DRUG SAFETY COMMUNICATION: NEW WARNINGS AGAINST USE OF TERBUTALINE TO TREAT PRETERM LABOR

February 18, 2011

American College of Obstetricians and Gynecologists. bronchospasm FDA preterm labor Terbutaline

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MEDICAL EXPERTS ISSUE WARNING ABOUT COMMON PRACTICE OF TABLET SPLITTING

January 14, 2011

Faculty of Pharmaceutical Sciences at Ghent University tablet splitting

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FDA LIMITS ACETAMINOPHEN IN PRESCRIPTION COMBINATION PRODUCTS; REQUIRES LIVER TOXICITY WARNINGS

January 14, 2011

acetaminophen FDA

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FDA DRUG SAFETY COMMUNICATION: SEVERE LIVER INJURY ASSOCIATED WITH THE USE OF DRONEDARONE (MARKETED AS MULTAQ)

January 14, 2011

Dronedarone FDA Multaq

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Abilify
acetaminophen
Acrux
acute coronary syndrome (ACS)
acute vaginismus
Adcetris
alanine aminotransferase (ALT)
American College of Obstetricians and Gynecologists.
and Invega
Anti myeloma

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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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