Kelly Davio

March 20, 2018

The FDA’s Center for Drug Evaluation and Research has launched its pilot to publicly release clinical study report (CSR) data from pivotal clinical trials as part of a greater push for agency transparency in the approval of new drugs.

March 19, 2018

A multi-center retrospective study of Japanese patients, newly published in PLOS One, sought to describe treatment persistence and reasons for discontinuation among patients who were treating their rheumatoid arthritis with 1 of 7 biologic agents: adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, tocilizumab, and abatacept.

March 16, 2018

Biosimilars of eculizumab, which have the potential to reduce costs for both patients and the healthcare system, have been eagerly awaited, yet many drug makers are developing novel anti-C5 agents.

March 15, 2018

Data on the use of rituximab in treating patients with systemic lupus erythematosus (SLE) has been far from clear; 2 randomized controlled trials of rituximab in patients with SLE failed to meet their primary endpoints, while open-label trials have reported the drug’s efficacy in this indication.

March 15, 2018

This week, Israel-based Protalix BioTherapeutics, Inc, announced positive results from a phase 2 clinical trial for its orally administered anti–tumor necrosis factor (anti-TNF) drug, OPRX-106, a plant cell–expressed recombinant human TNF receptor II fused to an IgG1 Fc domain.

March 14, 2018

For 4 drugs—Crestor, Lantus, Advair, and Humira—the United States had higher prices than did any other nation—even more than double the next highest price.

March 13, 2018

Randomized controlled trials have established the clinical efficacy and safety of infliximab in treating fistulizing Crohn disease (CD), and while evidence for adalimumab and vedolizumab in this indication is weaker, these drugs are also used in clinical practice, sometimes in treatment sequences of biologics, to treat fistulizing CD. In Europe, where access to biologic drugs is largely driven by budgetary considerations, biosimilars have the potential to improve access to treatment.

March 12, 2018

The study concludes that the VOLTAIRE-RA study showed that the biosimilar Cyltezo and reference Humira are highly similar, and that switching from the reference to the biosimilar had no impact on efficacy, safety, or immunogenicity.

March 10, 2018

This week, Senators Tom Cotton, R-Arkansas, and Claire McCaskill, D-Missouri introduced the Preserving Access to Cost-Effective Drugs (PACED) Act in response to Allergan’s recent transfer of its patents covering its dry-eye drug, Restasis, to the Saint Regis Mohawk Tribe in exchange for the Tribe’s invocation of sovereign immunity against inter partes review.

March 09, 2018

Not all stakeholders are convinced that UnitedHealthcare's newly announced change of policy is enough to offset the role that pharmacy benefit managers have had in rising out-of-pocket costs for consumers.