bioequivalence

Lyvispah — a dissolvable granular formulation of baclofen — is now commercially available in the U.S. for adults and adolescents, 12 and older, with spasticity associated with multiple sclerosis (MS) and other spinal cord disorders. In people with MS, the strawberry-flavored formulation is particularly suitable to ease flexor…

Bafiertam (monomethyl fumarate), a bioequivalent of Tecfidera to treat relapsing forms of multiple sclerosis (MS), is now available to patients in the U.S. through a network of specialty pharmacies, Banner Life Sciences, the therapy’s developer, announced. Banner previously stated that Bafiertam would arrive on the market…

The U.S. Food and Drug Administration (FDA) has given final approval to Banner Life Sciences’ Bafiertam (monomethyl fumarate), a bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate) to treat people with relapsing…

Using a patient-friendly autoinjector pen to take monthly doses of ofatumumab — an investigational B-cell therapy for relapsing multiple sclerosis (MS) — is bioequivalent to delivering it via a prefilled syringe, and would allow self-administration of the treatment at home, a study shows. Equal effects…

Banner Life Sciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Bafiertam (monomethyl fumarate), a novel bioequivalent of Biogen’s Tecfidera (dimethyl fumarate) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Final approval is expected no later than…

AXIM Biotechnologies has secured an additional $4 million in institutional financing to advance clinical trials of its cannabinoid therapies for multiple sclerosis (MS) and irritable bowel syndrome. Some of the trials involve a chewing-gum therapy delivery system. The financing will let the company continue developing a patented chewing-gum-delivered therapy for pain and spasticity. AXIM…