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Due to Potential Battery Failure Getinge’s Maquet / Datascope Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP)

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Due to Potential Battery Failure Getinge’s Maquet / Datascope Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP)

Nov 19, 2019: USFDA provides an update on failure related to Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices (Cardiosave Hybrid and Cardiosave Rescue).

From the previous letter to health care providers, the FDA informed providers about the devices shutting down while running on battery power, leading to pump stop and loss of hemodynamic support.

FDA has received over 60 additional medical device reports related to this issue, including two patient deaths and one serious patient injury after the previous communication on November 1, 2018.

The FDA continues to work with the manufacturer to inspect and deal with the root cause of these IABP devices shutting down while running on battery power. At present Maquet/Datascope is developing a Cardiosave battery maintenance software upgrade. https://www.fda.gov/medical-devices/letters-health-care-providers/update-device-failure-associated-getinges-maquetdatascope-intra-aortic-balloon-pumps-letter-health

First-in-human clinical trial to evaluate CAR-Treg Cell Therapy TX200 for Kidney Transplantation approved for Phase 1/2 Clinical Trial

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First-in-human clinical trial to evaluate CAR-Treg Cell Therapy TX200 for Kidney Transplantation approved for Phase 1/2 Clinical Trial

Nov 19, 2019: Sangamo Therapeutics announced that the UK Medicines Healthcare Products Regulatory Agency (MHRA) has granted authorization of the first-in-human clinical trial to evaluate a Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) therapy TX200  for the prevention of immune-mediated rejection following HLA-A2 mismatched kidney transplantation for end-stage renal disease (ESRD).

In 2020 Sangamo expects to open this  first clinical sites for the STEADFAST study.This inventive and personalized cellular therapy approach for HLA-A2 mismatched kidney transplantation is planned to regulate the body’s immune system specifically and locally to promote reception of an immunologically mismatched donor organ.

TX200 is an autologous (cells collected from the patient) HLA-A2-targeted CAR-Treg cell therapy. The patient’s regulatory T cells (Tregs)  plays vital role in regulating the immune response and inflammation, are collected and genetically engineered with a Chimeric Antigen Receptor (CAR) intended to bind to HLA-A2(protein).

TX200 HLA-A2 CAR-Treg cells are planned to accumulate and restrict within the new kidney where the HLA‑A2 protein is present, in order to utilizing the ability of Tregs to suppress immune responses against the transplanted kidney.

This aims to help the recipient’s immune system to  accept the new kidney and induce immunological tolerance, potentially allowing tapering and eventual elimination of accompanying standard-of-care immune suppressive treatments. https://investor.sangamo.com/news-releases/news-release-details/sangamo-announces-uk-authorization-phase-12-clinical-trial

KarXT enrolled in Phase II clinical trial for the treatment of acute psychosis in schizophrenia patients

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KarXT enrolled in Phase II clinical trial for the treatment of acute psychosis in schizophrenia patients

Nov 19, 2019: Karuna Therapeutics  announced  that KarXT assured for the treatment of acute psychosis in schizophrenia patient sign up in a Phase II clinical trial.

KarXT (xanomeline and trospium) stimulates muscarinic receptors in the central nervous system (CNS) and used for the treatment of psychosis and related symptoms. Xanomeline (muscarinic receptor agonist), while trospium (muscarinic receptor antagonist)are  expected to avoid the side effects that are seen with existing antipsychotic standard of care drugs.

Discontinuation and tolerated  rates of KarXT were found to be similar between the treatment and placebo arms.The adverse event (AE) rate with KarXT and placebo was found to be 54% and 43%, respectively. https://www.clinicaltrialsarena.com/news/karuna-therapeutics-schizophrenia-data/

TWILIGHT trial showed that Brilinta (ticagrelor) monotherapy reduced the risk of clinically relevant bleeding compared to dual antiplatelet therapy (DAPT) in patients with non-ST elevation acute coronary syndromes (NSTE-ACS)

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TWILIGHT trial showed that Brilinta (ticagrelor) monotherapy reduced the risk of clinically relevant bleeding compared to dual antiplatelet therapy (DAPT) in patients with non-ST elevation acute coronary syndromes (NSTE-ACS)

Nov 17, 2019: From subgroup analysis of the TWILIGHT trial in patients with non-ST elevation acute coronary syndromes(NSTE-ACS), Brilinta (ticagrelor) monotherapy reduced the risk of clinically relevant bleeding compared to dual antiplatelet therapy (DAPT).

NSTE-ACS subgroup analysis shows results like As compared to ticagrelor plus aspirin (3.6% vs. 7.6%, HR 0.47; 95% CI: 0.36-0.61), results showed by Ticagrelor monotherapy was found to be 4.0% risk reduction in bleeding.

Likewise, Thrombolysis in Myocardial Infarction (TIMI) major bleeding at one year was found to be 0.5% for ticagrelor plus placebo and 1.0% for ticagrelor plus aspirin.

Also the death rates in one year are (1.0% for ticagrelor plus placebo and 1.5% for ticagrelor plus aspirin), MI (3.1% and 3.1%), ischemic stroke (0.5% and 0.3%), and definite or probable stent thrombosis (0.4% and 0.6%).

Rates of other secondary endpoints also were similar between the two groups at one year – all-cause death. As concluded, there was a lower risk of bleeding compared with standard 12 months of dual antiplatelet therapy with ticagrelor plus aspirin. https://www.astrazeneca.com/media-centre/medical-releases/subgroup-analysis-of-twilight-trial-patients-with-nste-acs.html

Novartis Phase III PARAGON-HF study: Substantial reductions in heart failure with preserved ejection fraction with Entresto

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Novartis Phase III PARAGON-HF study: Substantial reductions in heart failure with preserved ejection fraction with Entresto

Nov 18, 2019: Novartis Phase III PARAGON-HF study plays a key role for patients with diastolic heart failure with preserved ejection fraction (HFpEF).

From the analysis, it was found that, as compared to valsartan, treatment with Entresto may result in substantial reductions in heart failure hospitalizations and cardiovascular death. Women with HFpEF or recently hospitalized for heart failure determine additional benefits.

In addition, in a collective analysis of PARAGON-HF (HFpEF) and PARADIGM-HF (heart failure with reduced ejection fraction (HFrEF)), better treatment assistance was observed in patients with left ventricular ejection fraction (LVEF) below approximately 60%.
https://www.novartis.com/news/media-releases/novartis-paragon-hf-analyses-suggest-entresto-benefit-beyond-hfref

Cardiff University’s scientist awarded the funding of £373k to diagnose pancreatic cancer at an earlier stage

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Cardiff University’s scientist awarded the funding of £373k to diagnose pancreatic cancer at an earlier stage

Nov 18, 2019: Dr Catherine Hogan at Cardiff University’s European Cancer Stem Cell Research Institute has been awarded the funding of £373k  by Cancer Research UK’s Early Detection Committee to understand new ways to diagnose pancreatic cancer at an earlier stage.

Her research showed that cells with the mutated KRAS gene (holds 90% of pancreatic cancer) are often eliminated due to protective mechanisms that keep the tissue healthy.

Nowadays many people survive with cancer and this doubled in the last 40 years in UK so funding awarded will helps a lot in investigating whether having more mutations in KRAS mutated cells enables them to avoid the protective mechanisms in the pancreas and initiate cancer development. https://www.cancerresearchuk.org/about-us/cancer-news/press-release/2019-11-06-cardiff-scientist-awarded-ps373k-to-find-new-ways-to-diagnose-pancreatic-cancer-earlier?_ga=2.170261608.979509868.1574138627-821077033.1573061409

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

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