Jackie Syrop


First Brazilian Study of Adalimumab to Treat Ulcerative Colitis Demonstrates Efficacy and Safety

December 29, 2017

Adalimumab demonstrated efficacy and safety in the treatment of patients with moderate to severe ulcerative colitis (UC) in the first Brazilian study to demonstrate the effectiveness and safety profile of the therapy in patients with UC.

Antidrug Antibodies Common, Significantly Impact Biologic Efficacy

December 28, 2017

Antidrug antibodies (ADAs) are commonly found in healthy subjects after a single intravenous dose of infliximab and result in faster clearance of infliximab, shorter elimination time, and lower serum infliximab levels, according to a study published in the September 2017 issue of Drugs in R&D by Eli D. Ehrenpreis, MD.

Biosimilar Accessibility, Expenditures Rising in Central, Eastern Europe

December 27, 2017

Biosimilar drugs significantly influence the reimbursement systems of 10 Central and Eastern European countries, and the expenditure on the reimbursement of biosimilars (percentage of drug price covered by public payers) in those countries is increasing as biosimilars become more accessible to patients.

Biologic Treatment in Patients With Axial Spondyloarthritis and Low Disease Activity

December 26, 2017

A Polish study of axial spondyloarthritis patients who discontinued treatment with anti–tumor necrosis factor (anti-TNF) therapy because of low disease activity found that more than half eventually needed to restart anti-TNF therapy.

GAO Report to Congress: Industry Changes Affect Drug Pricing

December 22, 2017

The US Government Accountability Office (GAO) reports that retail drug spending accounted for about 12% of total personal healthcare service spending in the United States in 2015, up from about 7% through the 1990s.

Report: Biosimilars Will Play Increasingly Important Role in US Biologic Market

December 22, 2017

Biologic drugs play a key role in the US healthcare market, as they are often the standard of care for treating complex diseases, many of which require long-term treatment. With the FDA’s approval of biosimilars of several important biologic treatments, and with a significant pipeline of biosimilars still in development, it is expected that many biosimilars will be introduced to the US market in the next several years.

Industry Group Spent Millions on Congress, Patient Orgs to Help Control Pricing Message

December 21, 2017

Tax disclosure forms for 2016 show that the pharmaceutical industry’s biggest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), raised revenue by almost one-fourth and spent the millions collected among hundreds of lobbyists, politicians, and patient groups—the largest income surge reported by the group since 2009, when it was mobilizing forces to advance the industry’s interests prior to the passage of the Affordable Care Act.

Tax Reform Bill Largely a Plus for Big Pharma

December 20, 2017

The tax reform bill proposed by Republicans and passed by the House this week contains benefits for many in the pharmaceutical industry. The reduction in the corporate tax rate from 35% to 21% will benefit all cash-flow-positive businesses, and the new, lower 15.5% rate for repatriating cash held overseas is likely to result in large companies becoming flush with cash, allowing them to buy back stock, increase shareholder returns, and fuel a wave of merger and acquisition (M&A) activity.

The Journey of Biosimilar Epoetin Alfa Serves as Example of Approval Pathway Integrity

December 18, 2017

Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.