Samantha DiGrande

June 06, 2018

The proposed biosimilar, TAB008, under development by TOT Biopharm, was compared with the reference bevacizumab in a randomized, double-blind, single-dose study conducted in 99 healthy adult males.

June 05, 2018

This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.

June 04, 2018

Mylan and its partner Biocon have received a Complete Response Letter from the FDA in regard to their application for a follow-on insulin glargine referencing Lantus.

June 02, 2018

This week, the FDA approved an expanded indication of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz) to include adults with moderate to severe ulcerative colitis. Tofacitinib is the first oral medicine approved for long-term use in UC, and provides an alternative to anti–tumor necrosis factor (anti-TNF) drugs that must be injected or infused.

June 01, 2018

This week, the Community Oncology Alliance (COA), which represents approximately 5000 community oncologists, announced that it has filed a lawsuit against HHS, HHS Secretary Alex Azar, the Office of Management and Budget (OMB), and the director of the OMB, Mick Mulvaney, in the District of Columbia to stop the departments from applying the Medicare sequester cut to reimbursement for Part B drugs.

May 31, 2018

Recently, the American Diabetes Association (ADA) released a set of policy recommendations to improve patient access to much-needed insulin and to lower the substantial cost to treat diabetes.

May 30, 2018

Vizient, a healthcare performance improvement company, recently voiced its concerns to the Office of the United States Trade Representative about proposed tariffs on Chinese products.

May 29, 2018

In collaboration with the National Heart, Lung, and Blood Institute, researchers from the Perelman School of Medicine at the University of Pennsylvania led a multicenter, randomized, double-blind, placebo-controlled study that compared the effect of adalimumab treatment of moderate to severe psoriasis or phototherapy on vascular inflammation and cardiovascular biomarkers.

May 28, 2018

Drug maker Lupin announced last week that its marketing authorization application for a proposed etanercept biosimilar, YLB113, was accepted by the European Medicines Agency.

May 26, 2018

EvaluatePharma recently released its take on the current state of the market for orphan drugs in its Orphan Drug Report for 2018.