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SurVaxM: A novel anti-cancer immunotherapy for the treatment of glioblastoma brain cancers

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SurVaxM: A novel anti-cancer immunotherapy for the treatment of glioblastoma brain cancers

Nov 15, 2019: Shanghai Fosun Pharmaceutical and MimiVax LLC have entered into a China-exclusive licensing agreement for the clinical development and commercialization of SurVaxM.

SurVaxM is first-in-class, patented peptide immunogen targeting Survivin Antigen on tumor cells, a novel anti-cancer immunotherapy in the treatment of newly diagnosed glioblastoma brain cancers.

Glioblastoma is an adult-common malignant neuroepithelial neoplasm in the central nervous system, the tumor has a fast growth rate, with 70-80% of patients surviving a disease course of only 3 to 6 months ( most devastating type in the WHO  classification  of central nervous system tumors).  

Presently, patient’s survival time is in the range of 14.5 to 16.6 months when treated with surgery, radiotherapy, chemotherapy and other supportive therapy.SurVaxM stimulates the production T-cell and B cell immunity simultaneously with unique cellular and antibody-mediated anti-tumor responses.

https://www.fosunpharma.com/en/news/news-details-3786.html

Initiation Of First Large-Scale Registry :To Evaluate Real-World Lipid Management And The Effectiveness Of PCSK9 Inhibitors

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Initiation Of First Large-Scale Registry :To Evaluate Real-World Lipid Management And The Effectiveness Of PCSK9 Inhibitors

Nov. 15, 2019: Amgen and the Duke Clinical Research Institute (DCRI) announced plans to initiate the Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 inhibitors (cvMOBIUS) study in order to calculate lipid management and the impact of PCSK9 inhibitors on cardiovascular (CV) outcomes.

The  study performed  across the U.S. and Canada and will start patient enrollment by this month.”The clinical evidence assisting  the efficacy and safety of PCSK9 inhibitors including Repatha® (evolocumab) in patients with cardiovascular disease is well established, but still there is lot to learn about the benefits of these medicines in the real world.”

One of the  most important modifiable risk factors for cardiovascular diseaseis “LDL-C, so lipid management is an vital element in reducing future CV events and improving clinical outcomes for high-risk patients.” https://www.amgen.com/media/news-releases/2019/11/amgen-and-the-duke-clinical-research-institute-announce-initiation-of-first-large-scale-registry-to-evaluate-real-world-lipid-management-and-the-effectiveness-of-pcsk9-inhibitors/

Single, subanesthetic-dose of ketamine infusion relatively free of side effects for patients with treatment-resistant depression

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Single, subanesthetic-dose of ketamine infusion relatively free of side effects for patients with treatment-resistant depression

Nov 15, 2019: NIH researchers found that a single, subanesthetic-dose of ketamine infusion was relatively free of side effects for patients with treatment-resistant depression symptoms within hours in people who have not responded to conventional antidepressants, which typically take weeks or months to work. No drug-related serious adverse events or increased ketamine cravings with a single-administration.”“side effect of ketamine infusion found like feeling strange or loopy, difficulty speaking, visual distortions,” most side effects peaked within an hour of ketamine administration and were gone within two hours.  https://www.nih.gov/news-events/news-releases/side-effects-mild-brief-single-antidepressant-dose-intravenous-ketamine

New Novartis medicine Adakveo® (crizanlizumab) approved by FDA for the treatment of individuals living with sickle cell disease

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New Novartis medicine Adakveo® (crizanlizumab) approved by FDA for the treatment of individuals living with sickle cell disease

Nov 15, 2019: FDA approved Novartis’s Adakveo (crizanlizumab-tmca) for the treatment to reduce the frequency of vaso-occlusive crisis in sickle cell disease for patients age 16 years and older. it is first targeted therapy of its kind. It inhibits selectin protein that contributes cell sticking and results in a vaso-occlusive crisis. The FDA granted Priority Review, Orphan Drug designation and Breakthrough Therapy designation for Adakveo. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-crizanlizumab-tmca-sickle-cell-disease

BMS and Pfizer to start a new randamized controlled trial accessing the impact of atrial fibrillation screening on health outcomes in older individuals

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BMS and Pfizer to start a new randamized controlled trial accessing the impact of atrial fibrillation screening on health outcomes in older individuals

Nov 16, 2019: PRINCETON, N.J. and Bristol-Myers Squibb-Pfizer Alliance announced the initiation of a new randomized controlled trial (GUARD-AF) for undiagnosed atrial fibrillation in elderly individuals.  The estimated case of AFib is about 8 million people in the U.S.  in 2019. https://www.pfizer.com/news/press-release/press-release-detail/bristol_myers_squibb_and_pfizer_announce_randomized_controlled_trial_to_evaluate_the_effect_of_atrial_fibrillation_screening_on_health_outcomes_in_older_individuals

FDA approves Talicia To Treat bacterial infection Linked To Stomach Cancer

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FDA approves Talicia To Treat bacterial infection Linked To Stomach Cancer

Nov 16, 2019: Bacterial infection affects millions of American adults in a year and is one of the strongest known causes of stomach cancer, Talicia could have a comprehensive impact in treating this infection. Talicia is a combination of omeprazole magnesium, amoxicillin and rifabutin used for the treatment of Helicobacter pylori (H. pylori) infection.

FDA approves Taliciaas it shows positive results of two Phase 3 studies in H. pylori-positive adult patients complaining of epigastric pain and/or discomfort. https://www.drugs.com/history/talicia.htmlhttps://www.drugs.com/newdrugs/fda-approves-talicia-omeprazole-magnesium-amoxicillin-rifabutin-h-pylori-infection-adults-5098.html

Zydus Cadila gets tentative approval from USFDA for Apremilast tablets for the treatment of psoriatic arthritis

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Zydus Cadila gets tentative approval from USFDA for Apremilast tablets for the treatment of psoriatic arthritis

Nov 16, 2019: USFDA approved Zydus Cadila’s Apremilast tablets for the treatment of psoriatic arthritis and moderate to severe plaque psoriasis. The US health regulator to market generic to market the tablets in the strengths of 10 mg, 20 mg, and 30 mg. https://zyduscadila.com/

New antibacterial drug approved by FDA to treat complicated urinary tract infections for antimicrobial resistance

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New antibacterial drug approved by FDA to treat complicated urinary tract infections for antimicrobial resistance

Nov 14, 2019: The U.S. Food and Drug Administration (FDA)  approved Shionogi’s Fetroja (cefiderocol), an antibacterial drug used for the patients of 18 years of age or older with complicated urinary tract infections (cUTI), also kidney infections caused by susceptible Gram-negative microorganisms.

Patients known history of severe hypersensitivity to beta-lactam antibacterial drugs are restricted to use this drug. https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibacterial-drug-treat-complicated-urinary-tract-infections-part-ongoing-efforts

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