Glatiramer Acetate

Zydus Launches ANVIMO: Game-Changing CMV Prevention Drug for Transplant Patients at 91% Lower Cost

3 months ago

• Zydus Lifesciences introduces ANVIMO (letermovir) in India, offering a breakthrough treatment for preventing Cytomegalovirus infection in stem cell and kidney transplant patients. • The new drug demonstrates superior safety profile and reduced side effects compared to traditional treatments, while maintaining bioequivalence with the reference drug. • ANVIMO's launch dramatically reduces treatment costs by 91% compared to imported alternatives, making critical CMV prophylaxis more accessible to Indian transplant patients.

GA Depot Shows Promise in Progressive MS with 3-Year Stability in Disability Scores

3 months ago

• Phase 2 study results demonstrate GA Depot's safety profile in progressive MS patients, with stable EDSS scores maintained over three years and minimal disability progression. • The long-acting, monthly treatment showed encouraging efficacy with 69% of patients exhibiting no evidence of progression and high stability rates in mobility and hand function tests. • Treatment was well-tolerated with predominantly mild adverse events, particularly at the 25mg dose, supporting advancement to a global phase 3 trial.

FDA Adds Boxed Warning to Glatiramer Acetate for Anaphylaxis Risk

4 months ago

• The FDA has issued a boxed warning for glatiramer acetate, a multiple sclerosis drug, due to the risk of anaphylaxis. • The warning applies to both brand-name (Copaxone) and generic versions (Glatopa) of the medication. • Anaphylaxis can occur at any time during treatment, even after months or years of use, and may require hospitalization. • Healthcare providers are advised to educate patients on anaphylaxis symptoms and the need for immediate medical attention.

Teva's Long-Acting Schizophrenia Drug Rejected by FDA

4 months ago

The FDA has declined to approve Teva's long-acting formulation of schizophrenia drug risperidone, dealing a blow to the company's turnaround efforts. Despite positive phase 3 trial results, the reasons for the rejection remain undisclosed, with Teva and partner MedinCell planning to address the FDA's concerns.

FDA Approves Mylan's Generic Versions of Copaxone for Multiple Sclerosis Treatment

8 years ago

• The FDA has approved Mylan's glatiramer acetate injections in two dosage forms (40 mg/mL three-times-weekly and 20 mg/mL once-daily) as therapeutically equivalent alternatives to Teva's Copaxone for relapsing forms of multiple sclerosis. • Mylan's generic versions demonstrated the same active ingredient, dosage form, route of administration, and strength as Copaxone, allowing them to be substituted with comparable safety and efficacy profiles. • Alongside the medication launch, Mylan introduced the comprehensive MS Advocate support program offering injection training, 24/7 patient support, co-pay assistance, and ongoing nurse support to help patients adhere to their treatment plans.