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Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets for the treatment of Angina and Desonide Cream for skin diseases

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Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets for the treatment of Angina and Desonide Cream for skin diseases

Nov. 21, 2019: Zydus Cadila has received the final approval from the USFDA for marketing Isosorbide Dinitrate Tablets USP ( 5 mg, 10 mg, 20 mg, 30 mg and 40 mg)  to prevent attacks of Angina (chest pain).

These tablets dilate blood vessels, increases blood flow through to the heart. These will be manufactured at the group’s formulations manufacturing facility at Baddi. The group also received the final approval for Desonide Cream (US RLD – Desonide Cream), 0.05%.

The drug is a mild corticosteroid, used to treat a multiplicity of skin conditions (e.g., eczema, allergies, dermatitis, rash)in order to reduce swelling, itching and redness. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. https://zyduscadila.com/public/pdf/pressrelease/Zydus_receives_final_approvals_from_the_USFDA_for_Isosorbide_Dinitrate_Tablets_and_Desonide_Cream.pdf

Astellas and Welldoc together develop and commercialize BlueStar® a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for the treatment of type 1 or type 2 diabetes

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Astellas and Welldoc together develop and commercialize BlueStar® a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for the treatment of type 1 or type 2 diabetes

Nov 20, 2019  – Astellas Pharma Inc. and Welldoc, Inc. announced that the companies have entered into a collaboration and license agreement directed toward the development and commercialization of digital health solutions, BlueStar® in Japan and certain other Asian markets for patients with diabetes.

U.S. Food and Drug Administration (FDA)- in the United States cleared the use of BlueStar  by healthcare providers and their patients aged 18 years and older who have type 1 or  type 2 diabetes. It not only assists patients in managing their disease by capturing ,transmitting blood glucose data and tracking medication, activity, diet and exercise, but also useful for  individual patient treatment data and machine learning to provide customized motivational, behavioral, and educational training messages to aid in diabetes self-management. https://www.astellas.com/en/news/15441

Officials:Blackberries sold in Fresh Thyme grocery stores cause hepatitis A

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Officials:Blackberries sold in Fresh Thyme grocery stores cause hepatitis A

Nov 21,2019: Consumers of 11 states are warned by Nebraska and federal health officials as hepatitis A outbreak that includes Nebraska, Indiana and Wisconsin has been traced to blackberries sold in Fresh Thyme grocery store

https://www.washingtonpost.com/business/officials-multistate-hepatitis-a-cases-traced-to-berries/2019/11/20/fecb0be4-0bf3-11ea-8054-289aef6e38a3_story.html

NGFA–KSU Food Safety Modernization Act Feed Industry Training course to set regulations for safe animal feed

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NGFA–KSU Food Safety Modernization Act Feed Industry Training course to set regulations for safe animal feed

Nov. 20, 2019: FDA has issued final regulations under the Food Safety Modernization Act that require feed facilities to comply with new current good manufacturing practices and to implement a written animal food safety plan that is developed and overseen by a preventive controls qualified individual.

This training was held on November 5–7, 2019 and allowed participants to learn about the fundamentals and manufacturing principles of food safety and how to create an effective food safety plan.

This three day course focuses on improving overall food safety where people from the industry come to learn about new regulations.

There are certificates training from the Food Safety Preventive Controls Alliance (FSPCA) for the  Participants, as well as an additional Hazard Analysis and Critical Control Point (HACCP) training to recieive the certificate, participants must  demonstrate the requirements by Preventative Controls Qualified Individual (PCQI) per the FDA’s regulations.
https://fda.einnews.com/article__detail/502768398-k-state-university-igp-institute-holds-ngfa-ksu-food-safety-modernization-act-training-course?vcode=XIbw

USFDA Approved GIVLAARI(givosiran) for the Treatment of Adults with Acute Hepatic Porphyria

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USFDA Approved GIVLAARI(givosiran) for the Treatment of Adults with Acute Hepatic Porphyria

Nov. 20, 2019: Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced  the USFDA approved GIVLAARI™ (givosiran) injection (subcutaneous) for the treatment of adults with acute hepatic porphyria (AHP).

AHP is an exceptional, genetic diseases characterized by devitalizing, potentially life-threatening attacks and, for some patients, chronic manifestations that depressingly impact daily performance and quality of life.

Long-standing complications of AHP are chronic neuropathic pain, chronic kidney disease, hypertension and liver disease. GIVLAARI reduces the rate of porphyria attacks that required hospitalizations, urgent healthcare visits or IV hemin administration at home. http://investors.alnylam.com/news-releases/news-release-details/alnylam-announces-approval-givlaaritm-givosiran-us-food-and-drug

Merck’s anti-PD-1 therapy KEYTRUDA(pembrolizumab) for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

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Merck’s anti-PD-1 therapy KEYTRUDA(pembrolizumab) for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Nov 20,2019: For the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1),Merk announced that the European Commission has approved KEYTRUDA(pembrolizumab) as Merck’s anti-PD-1 therapy, a monotherapy or in combination with platinum and 5-fluorouracil (5-FU).

This approval  based on reports from the pivotal Phase 3 KEYNOTE-048 trial, in which KEYTRUDA, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), demonstrated a significant enhancement in overall survival (OS) as monotherapy and in combination with chemotherapy in patients whose tumors expressed PD-L1 (CPS ≥1).

From this disease  patient’s appearance and their daily functions, such as eating and speaking get affected.

KEYTRUDA monotherapy and combination regimen cover the market of all 28 EU member states plus including Iceland, Lichtenstein and Norway.KEYTRUDA 200 mg injection (IV) for every three weeks. https://www.mrknewsroom.com/news-release/oncology/european-commission-approves-two-new-regimens-mercks-keytruda-pembrolizumab-fi

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

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