Kelly Davio

August 15, 2017

The European Medicines Agency announced this month that it has initiated a business continuity plan to cope with the political uncertainty and the workload implications of the United Kingdom’s impending withdrawal from the European Union.

August 14, 2017

Ireland’s Minister for Health has published a consultation paper on overhauling the nation’s approach to biosimilar medicines. The paper indicates that the Irish government is developing a National Biosimilar Medicines Policy “to promote the rational use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”

August 12, 2017

Price competition in the US insulin market is heating up; Novo Nordisk reported in its second-quarter earnings call that its 2018 US insulin prices could drop below 2017 levels.

August 11, 2017

Insurers operating in the Affordable Care Act marketplace face fresh uncertainties as they plan for 2018: whether Congress will continue in its efforts to repeal or replace the ACA, whether the Trump administration will enforce the individual mandate, or even whether the federal government will continue to pay insurers for cost-sharing reductions are all unanswered questions.

August 10, 2017

A recently published study demonstrates that sarilumab improves patient-reported outcomes in patients with rheumatoid arthritis who did not achieve adequate response with, or who were intolerant to, anti-tumor necrosis factor (anti-TNF) agents.

August 09, 2017

Coherus BioSciences announced this week that it has filed a petition for inter partes review of a key patent protecting Amgen’s etanercept (Enbrel). Patent 8,163,522 (also known as the ‘522 patent) concerns a process for isolating non-soluble proteins.

August 08, 2017

Kyle F. Skiermont, PharmD, COO of Fairview Pharmacy Services, spoke with The Center for Biosimilars® about his experience with payers and providers as they prepare for the impact of biosimilar drugs and possible non-medical switching.

August 08, 2017

The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. ​​The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.

August 08, 2017

New York-based Regeneron has announced that it will allow one of its key partnerships with the French drug maker Sanofi to terminate at the end of the year without an extension. The companies’ Antibody Discovery Agreement was responsible for the discovery and development of such drugs as alirocumab (Praluent), dupilumab (Dupixent), and sarilumab (Kevzara).

August 04, 2017

The FDA’s Arthritis Advisory Committee (AAC) did not recommend the approval of Janssen Biotech’s sirukumab, a proposed monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis, over concerns about mortality.