The Indian Health ministry has taken different steps to ease the conductance of clinical trials in India by creating strong regulatory platform for ensuring safety, rights and well beings of the clinical research.
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Australian oncology-focused biotechnology company Novogen Ltd announced that it has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) for Cantrixil (TRX-E-002-1) in ovarian cancer.
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Neurotrope, Inc. announced that its wholly owned subsidiary, Neurotrope BioScience, Inc., has submitted to the Food and Drug Administration (FDA) an amended protocol for its Phase 2 clinical trial of lead candidate bryostatin-1 for the treatment of advanced Alzheimer’s disease. As planned in the original protocol, the primary efficacy outcome will occur at Week 13, and does not change with this amendment.
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- Read more about Ascendis Pharma begins phase 3 study of transcon growth hormone in children with GHD
Ascendis Pharma A/S, a clinical stage biopharmaceutical company that applies its innovative TransCon technology to address significant unmet medical needs, announced the initiation of the global phase 3 TransCon Growth Hormone heiGHt Trial in children with growth hormone deficiency (GHD).
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Acacia Pharma show Positive Pivotal Phase 3 Trial result of BAREMSIS
Acacia Pharma Group plc, the supportive care company developing products for US and international markets, announces positive results from a pivotal Phase 3 study investigating BAREMSIS™ (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (“PONV”). -
Intestinal flora has multiple influences on human health, but researchers have revealed that it is also likely to have an effect on the body's response to drugs. Recent research from Kumamoto University in Japan strongly suggests that changes in the intestinal flora, caused by antibacterial and antibiotic drugs or individual differences between people, may have an effect on a person's response to drugs including side effects. The research focused on the changes in proteins due to the condition of intestinal flora that affect the response to drugs in the liver and kidneys.
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USC researchers have tracked down two Zika proteins potentially responsible for thousands of microcephaly cases in Brazil and elsewhere -- taking one small step toward preventing Zika-infected mothers from birthing babies with abnormally small heads.
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Tuberculosis (TB) is a leading killer of people with HIV, and providing therapy for both illnesses simultaneously saves lives - according to new guidelines on the treatment of drug-susceptible TB developed jointly by the American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC) and Infectious Diseases Society of America (IDSA). Treatment of TB in the presence of HIV infection is one of several special situations addressed in the new guidelines, published today in the journal Clinical Infectious Diseases.
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Advaxis, Inc. announced that its Phase 2 “window of opportunity” clinical study of its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with late-stage HPV-associated oropharyngeal cancer (HPVOPC) met its stage 1 primary objective and is advancing into the second stage of the clinical study.
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Mallinckrodt plc, a leading global specialty pharmaceutical company, announced that it has entered into a merger agreement with Stratatech Corporation, a privately held regenerative medicine company focused on the development of unique, proprietary skin substitute products. Developmental products include StrataGraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. Financial terms of the transaction were not disclosed.
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