FDA Rejects Viatris, Mapi’s Long-Acting Multiple Sclerosis Injection
For three years, Teva has been defending against claims from the U.S. government that it paid illegal kickbacks to boost sales of its multiple sclerosis drug Copaxone. Now, with a trial just weeks away, Teva has scored a delay to pursue a unique appeal strategy.
LONDON, July 26 (Reuters) - Obesity drugs will not join the World Health Organization's (WHO) latest essential medicines list, but treatments for diseases, including Ebola and multiple sclerosis will, documents published by the U.N. agency showed.
Study suggests stem cell transplants may delay disability longer than some other medications in patients with active secondary progressive multiple sclerosis.
FDA is alerting patients, caregivers, and health care professionals that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for use across FDA-approved glatiramer acetate injection drug products. FDA has received reports that using an autoinjector that is not compatible with the patient’s specific glatiramer acetate injection drug product has resulted in missed and partial doses.
Israel has sued Teva for $100 million in royalties on the longer-lasting version of the medicine, Globes reports. While Teva owns Copaxone marketing rights, scientists at the Weizmann Institute of Science developed the medicine, the publication reports.
AMSTERDAM--(BUSINESS WIRE)--Teva Pharmaceuticals Europe BV confirms that the SmPC for COPAXONE® (Glatiramer Acetate (GA) injection) 20mg/mL and 40mg/mL, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in Europe, has been updated. The product is now approved by EU health authorities for use in breastfeeding. The label update follows the review of clinical and non-clinical evidence, including latest data from the COBRA real world evidence study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months of life.
Losing memory is a hallmark of Alzheimer's, a symptom of the disease that depletes a patient's quality of life. Improving memory and slowing cognitive changes caused by the disease is an ongoing challenge for researchers seeking to develop novel therapies. In a newly published paper in Frontiers in Neuroscience, researchers at the Del Monte Institute for Neuroscience at the University of Rochester found that glatiramer acetate, a prescription drug currently used to treat patients with multiple sclerosis (MS), improved memory in a mouse model of Alzheimer's disease.
Austedo turned in $201 million in third-quarter sales, a 19% increase from the $168 million it generated during the same period last year. The third-quarter haul brings Austedo's sales so far this year to $520 million, a notable increase from the $451 million the drug generated in the first 9 months of 2020.
AMSTERDAM--(BUSINESS WIRE)--Teva Pharmaceuticals Europe BV, a European affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and St. Josef Hospital – Katholisches Klinikum Bochum (Bochum, Germany), presented today at ECTRIMS congress new analyses of the COBRA study, a real-world evidence study on the safety of COPAXONE® (glatiramer acetate or GA) used by mothers with multiple sclerosis (MS) during pregnancy and breastfeeding.