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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.

  • 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.

  • 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.

  • 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.

  • SANUWAVE Health, Inc. announced that it has submitted to the U.S. Food and Drug Administration (FDA) a de novo petition requesting Agency review and classification of the dermaPACE System for treating Diabetic Foot Ulcers (DFU) as a Class II device. Through the course of two trials, 336 patients were randomized in double-blind, parallel group, sham controlled, multicenter, 24-week pivotal clinical trials that were designed to quantify the safety and effectiveness of the noninvasive procedures with the dermaPACE System (dermaPACE®).

  • Eli Lilly and Company announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. The MONARCH 2, phase 3 trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

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