CLINSQUARE: CLINICAL RESEARCH COURSES
Wednesday, February 5, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 150

Only treatment approved in the US for relapsed or refractory hairy cell leukemia Approved by FDA at ASH 2019

admin
-
0
Only treatment approved in the US for relapsed or refractory hairy cell leukemia Approved by FDA at ASH 2019

Dec. 08, 2019: Innate Pharma shared new, long-term data from the pivotal Phase III trial of Lumoxiti (moxetumomab pasudotox-tdfk) at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, USA. 

The final analysis showed that 36 percent (29/80) of the relapsed or refractory hairy cell leukemia patients achieved strong response (CR) with Lumoxiti at Day 181 of patient’s respective evaluation as compared to the primary analysis in which 30 percent durable CR rate was reported.

Also, there was a 61 percent probability of the patients who achieved a CR would maintain it after five years.

The single-arm, multi-center, open-label Phase III ‘1053’ clinical trial assessed the efficiency, safety, immunogenicity and pharmacokinetics of Lumoxiti monotherapy in 80 patients with relapsed or refractory hairy cell leukemia who had already received at least two prior therapies, including one purine nucleoside analog. https://fda.einnews.com/pr_news/504317616/innate-pharma-highlights-fda-approved-lumoxiti-at-ash-2019

Amgen’s AVSOLA™ received FDA approval for AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)for the treatment of Rheumatoid Arthritis, Crohn’s Disease, Ulcerative Colitis, Psoriatic Arthritis

admin
-
0
Amgen’s AVSOLA™ received FDA approval for AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)for the treatment of Rheumatoid Arthritis, Crohn’s Disease, Ulcerative Colitis, Psoriatic Arthritis

Dec. 6, 2019: U.S. FDA has approved Amgen’s  AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA),ankylosing spondylitis (AS),ulcerative colitis (UC) in the adult and pediatric population, AVSOLA (monoclonal antibody), an anti-tumor necrosis factor alpha (anti-TNF) was proven to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence which incorporated comparative analytical, nonclinical and clinical data.

The randomized, double-blind comparative clinical trial study evaluated the efficacy and safety of AVSOLA as compared to Remicade in patients with moderate-to-severe RA.

There were 558 patients enrolled and randomized (1:1) to receive either AVSOLA or Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter. The primary endpoint was the response difference (RD) of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22. Key secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46 and 50. The study also incorporated the evaluation of a single transition in 119 subjects from Remicade to AVSOLA at week 22, which demonstrated similar safety and immunogenicity in patients who were previously on Remicade. 

Amgen has a total of 10 biosimilars in its portfolio,Ou of which four approved in the U.S. and 3 are approved in the European Union (EU). https://www.amgen.com/media/news-releases/2019/12/fda-approves-amgens-avsola-infliximabaxxq-for-the-same-indications-as-remicade-infliximab/

ViiV Healthcare submits New Drug Application to the US FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults

admin
-
0
ViiV Healthcare submits New Drug Application to the US FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults

Dec 05, 2019: ViiV Healthcare have completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in search of approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.

Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are not able to form a oppressive regimen due to resistance, intolerance or safety considerations.

For the people living with HIV Fostemsavir may provide an imperative treatment option for the group.

This submission is supported by the data from the pivotal phase III BRIGHTE study in significantly treatment-experienced people living with multidrug-resistant HIV.

The results (96-week) from the BRIGHTE study were most recently presented in July at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City. https://viivhealthcare.com/en-us/us-news/us-articles/2019/viiv-healthcare-submits-new-drug-application-to-the-fda-for-fost/

FDA authorizes marketing of diagnostic test cobas vivoDx that uses novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacteria

admin
-
0
FDA authorizes marketing of diagnostic test cobas vivoDx that uses novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacteria

Dec 05, 2019: Roche Molecular Systems Inc. received U.S. Food and Drug Administration approval for marketing of a new diagnostic test (Cobas vivoDx) based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization to prevent and control MRSA in high-risk settings.

If a patient develops an infectionwith MRSA can lead to serious illness and even death. According to the Centers for Disease Control and Prevention (CDC), Not more than 5% of U.S. hospital patients carry the MRSA bacteria and many of those that carry the bacteria do not develop infections.

The cobas vivoDx MRSA test uses a new bacteriophage technology which is based on bioluminescence in order to detect MRSA from nasal swab samples in as little as 5 hours compared to 24-48 hours for conventional culture.

The FDA reviewed data from the performance studies in which the cobas vivoDx MRSA test precisely identified MRSA in roughly 90% of samples where MRSA was present and correctly identified no MRSA in 98.6% of the samples that didn’t have MRSA present. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-diagnostic-test-uses-novel-technology-detect-mrsa-bacteria

First investigational drug therapy for liver disease non alcoholic steatohepatitis (NASH) awaiting FDA approval

admin
-
0
First investigational drug therapy for liver disease non alcoholic steatohepatitis (NASH) awaiting FDA approval

Dec. 05, 2019: A large Phase III clinical trial designed in collaboration with Virginia Commonwealth University is the first to demonstrate the safety and effectiveness of an oral medication to patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease and a leading cause for liver transplantation in the U.S.(currently lack an approved drug therapy, but this may soon change).

As per the Results from the interim analysis of the REGENERATE study, sponsored by the Intercept Pharmaceuticals, will publish in the medical journal The Lancet this week.

Approximately 7 million and 30 million U.S. adults suffer from this desease, a severe form of fatty liver disease (unrelated to alcohol abuse) but closely related to obesity and Type 2 diabetes.

Patients suffering from NASH, fat deposited in the liver damages causes inflammation. NASH can progress in order to  include scarring, called fibrosis, which prevents the liver from functioning properly which can lead to liver cancer, liver failure or death. https://www.eurekalert.org/pub_releases/2019-12/vcu-fid120519.php

Data fron XOSPATA® in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting

admin
-
0
Data fron XOSPATA® in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting

Dec. 3, 2019: Astellas Pharma Inc. announced the presentation of new data in acute myeloid leukaemia (AML) at the 61st American Society of Hematology (ASH) Annual Meeting(Dec. 7-10) in Orlando, Fla.

Seven abstracts sponsored from  Astellas focus on patients with relapsed (a disease that has returned) or refractory (resistant to treatment) AML through an FLT3 mutation (FLT3mut+).

New findings from abstracts include the Phase 3 ADMIRAL trial – an oral presentation on emerging mutations in patients who  has develop resistance after an initial response to XOSPATA (gilteritinib) and also two poster presentations focused on patient-reported outcomes, as well as data on cost-effectiveness  testing and treatment patterns and venetoclax combination therapy. https://www.astellas.com/en/news/15466

First generics of Gilenya approved by FDA for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients

admin
-
0
First generics of Gilenya approved by FDA for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients

Dec 05, 2019: The U.S. Food and Drug Administration approved three applications for the first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body more frequently in women than men.

Fingolimod risks include slowing of the heart rate, especially after the first dose, may also increase the risk of serious infections. Patient taking this drug are reported with a rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported. https://fda.einnews.com/pr_news/504090689/fda-approves-first-generics-of-gilenya

U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Alecto’s investigational therapeutic AL001, for the treatment of patients with frontotemporal dementia

admin
-
0
U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Alecto’s investigational therapeutic AL001, for the treatment of patients with frontotemporal dementia

Dec. 05, 2019: U.S. Food and Drug Administration (FDA) has granted Fast Track designation for  Alecto’s investigational therapeutic, AL001, for the treatment of patients with frontotemporal dementia (FTD) carrying specific genetic mutations in the granulin gene (FTD-GRN).

It is currently evaluated in a Phase 2 trial for the treatment of FTD-GRN and FTD-C9orf72. Fast Track designation is intended to facilitate the development and accelerate the review of therapies for serious conditions and fill an unmet medical need.

Programs with Fast Track designation possibly will benefit from the early and frequent communications with the FDA, potential priority review, and additionally a rolling submission of the marketing application.

AL001 is a monoclonal antibody designed to modulate progranulin, a regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, including FTD, Alzheimer’s disease, and Parkinson’s disease.

It increases the level of progranulin in humans by inhibiting a progranulin degradation mechanism, AL001 discovered and engineered in collaboration of Alector and Adimab, LLC. https://fda.einnews.com/pr_news/504092810/alector-announces-fda-fast-track-designation-granted-to-al001-for-the-treatment-of-patients-with-frontotemporal-dementia

U.S. FDA approved BMS Breakthrough Therapy Designation for ORENCIA® (abatacept) just to help in Preventing Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

admin
-
0
U.S. FDA approved BMS Breakthrough Therapy Designation for ORENCIA® (abatacept) just to help in Preventing Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

DEC 04, 2019: Bristol-Myers Squibb Company  announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.

GvHD after a hematopoietic stem cell transplant occurs when transplanted donor T-cells recognize antigenic differences between donor and recipient and attacks the recipient’s healthy tissue and organs.

Stem cell transplant infusions include donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders in the recipient’s body including cancer cells.

GvHD occurs when the donor T-cells also recognize the patient’s healthy cells as foreign and start attacking healthy tissues and organs. 

T-cell activation requires a signaling process called co-stimulation. ORENCIA, a therapy currently approved to treat various arthritic conditions, binds to and inhibits protein targets involved in co-stimulation, thus inhibiting T-cell activation.

ORENCIA® is an immunomodulator that disrupts the continuous cycle of T–cell activation that characterizes Rheumatoid Arthritis. https://news.bms.com/press-release/rd-news/bristol-myers-squibb-announces-us-fda-breakthrough-therapy-designation-orencia

U.S. Food and Drug Administration (FDA) approved Investigational New Drug (IND) application for Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy

admin
-
0
U.S. Food and Drug Administration (FDA) approved Investigational New Drug (IND) application for Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy

Dec. 04, 2019: Innovative Cellular Therapeutics (ICT) announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ICTCAR014 (next generation CD19-targeting CAR-T cell therapy) that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells.

Data presented in November at the Society for Immunotherapy of Cancer (SITC) represents objective response rate of over 92%, the ICTCAR014 program highlights our accelerated and de-risked approach for developing novel immunotherapies. https://fda.einnews.com/pr_news/503959110/innovative-cellular-therapeutics-announces-fda-clearance-of-ind-for-its-dominant-negative-pd-1-armored-next-generation-car-t-cell-therapy

Ardelyx’s kidney disease drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD)

admin
-
0
Ardelyx’s kidney disease drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD)

Dec 04, 2019, Ardelyx lnc said about its experimental drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD) in a late-stage study.

As per reports, tenapanor showed a greater difference in serum phosphorus levels compared to placebo.

Approx 70% of CKD patients on dialysis continue to experience elevated phosphorus levels, also called hyperphosphatemia , at any point in time, the company said despite treatment with phosphate binders.

Iin September Ardelyx said that in another late-stage study patients treated with tenapanor and phosphate binders, the only approved therapy for hyperphosphatemia, showed a significant reduction in serum phosphorus levels compared to phosphate binders alone.

Tenapanor if approved will be the only non-binder treatment for high serum phosphorus levels in patients with chronic kidney disease on dialysis.
https://ardelyx.com/what-we-do/

United States Food and Drug Administration (USFDA) approved Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of cancers in adult patients

admin
-
0
United States Food and Drug Administration (USFDA) approved Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of cancers in adult patients

December 04, 2019: Dr Reddy’s Laboratories  launched Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of certain types of cancers in adult patients, in the US market approved by the United States Food and Drug Administration (USFDA).

This product is for intravenous use only for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who already  received at least one prior therapy.

Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester) that After reconstitution, 1 ml of solution for intravenous injection contains 1 mg  bortezomib. https://www.drugs.com/uk/bortezomib-dr-reddys-3-5-mg-powder-for-solution-for-injection-leaflet.html

1...149150151...156Page 150 of 156

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved