FDA approved the oral multiple sclerosis drug March 27 to treat patients with relapsing forms of the disease. Labeling includes data from one trial that showed patients on Tecfidera experienced disability progression less often.
Biogen Inc. received FDA approval March 27 for Tecfidera (dimethyl fumarate) with labeling that allows the firm to market the oral multiple sclerosis drug’s ability to delay disability progression.
The company did not immediately release details of the launch, but CEO George Scangos noted in a fourth quarter earnings...
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Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.
Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.
Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.
The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.
