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European Union: Pharmaceutical sector investigations signal increased focus on innovation-related theories of harm
07 Jun 2024 11:54 GMT
… main active ingredient (glatiramer acetate) included in … promotional and medical communications about its treatment’s safety … include: finished dose pharmaceuticals and outlicensing markets defined … in the adjacent biotechnology industry signals the …
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Dosing Commenced in Study of Anti-Tau Agent, FDA Updates Labeling to Glatiramer Acetate Products, Eisai Initiates Rolling Submission for Subcutaneous Lecanemab
18 May 2024 11:30 GMT
… ), double-blind, placebo-controlled trial, is conducted at a single … FDA has issued an update to the labeling of glatiramer acetate … . The increased risk for medications errors, such as a … intended to facilitate easier treatment of the drug, thus reducing the …
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Cross-Compatibility Issues With Autoinjectors Highlighted in New FDA Labeling Update of Glatiramer Acetate Injection
17 May 2024 00:53 GMT
… in November 2023.
In the trial, treatment with GA Depot led to … ;/www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients … , Patel P, Bajaj T. Glatiramer. National Library of Medicine. Updated February 28, 2024 …
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Compatibility issues found with autoinjectors, FDA says
17 May 2024 17:08 GMT
… with glatiramer acetate injections, there is an increased risk for medication errors … agency said May 16.
Teva Pharmaceuticals'; Copaxone does not have … ;s glatiramer acetate injection is only compatible with WhisperJECT. The FDA said these …
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Starting MS Treatment with Mild-to-Moderate Efficacy DMT More Likely to Result in Switch to High-Efficacy DMT
13 May 2024 20:15 GMT
… DMTs are generally older drugs that may have lower … suggests that starting MS treatment with a high-efficacy … the mild-to-moderate efficacy treatment glatiramer acetate. More patients who … They propose that longer treatment strategy studies are necessary to …
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FDA Approved Drug Products Approval List March 2024
30 Mar 2024 10:39 GMT
… ORIG-1 RIFAXIMIN NORWICH PHARMACEUTICALS INC Tentative Approval 03 … 761044 SUPPL-13 USTEKINUMAB JANSSEN BIOTECH Approval 03/ … #090218 SUPPL-28 GLATIRAMER ACETATE SANDOZ Labeling Approval … SUPPL-15 PRALSETINIB BLUEPRINT MEDICINES Labeling Approval 03…
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FDA Rejects Regeneron’s Blood Cancer Therapy for Two Forms of Lymphoma
25 Mar 2024 18:15 GMT
… s efficacy or safety, trial design, labeling or manufacturing … of treatment. However, the FDA required that the trials include … European Medicines Agency started a regulatory review of the drug, … FDA rejected Viatris and Mapi Pharma’s formulation of glatiramer …
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Are new treatments for multiple sclerosis on the horizon?
27 Mar 2024 18:35 GMT
… treatments for multiple sclerosis?
Currently available medicines include disease-modifying drugs … BTK inhibitor clinical trials
French biopharma Sanofi’ … trial flops in a report by Fierce Biotech. … the FDA with their immunomodulatory drug glatiramer acetate …
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FDA Updates for Week of March 11: First CAR-T for CLL/SLL and First NASH Treatment
16 Mar 2024 18:54 GMT
… B-cell lymphoma. Treatments primarily consist of targeted … Mirum Pharmaceuticals, Livmarli was approved by the FDA in … medications. I
FDA Issues CRL for Monthly MS Drug
The FDA … from attacking myelin. Available glatiramer acetate therapies involve injections …
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Revolutionizing Antiviral Therapeutics: Unveiling Innovative Approaches for Enhanced Drug Efficacy
20 Mar 2024 14:33 GMT
… in either treatment-experienced or treatment-naive individuals … of two FDA-approved medications, sitagliptin (SIT) and glatiramer acetate ( … participated in clinical trials using these colloidal … of molecular pharmaceutics:
Nanoparticle Drug Delivery Systems
…