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 •  December 21, 2017

Rarely does a week seem to pass without the pharmaceutical and biotechnology industry coming under considerable fire for the perceived high pricing of drugs. Whether it’s President Trump stating that, “drug prices are out of control,” the introduction of new legislation in the UK to regulate prices, or the creation of a new panel in India to...

www.pharmexec.com

 •  November 22, 2017

A growing volume of combination products, particularly for cutting-edge gene and cellular therapies and other new medical technologies, is creating challenges for FDA’s Office of Combination Products (OCP) and its role in advising on whether a new combination therapy should be designated as a drug, biologic, or device. OCP receives hundreds of...

www.pharmexec.com

 •  November 7, 2017

Despite FDA approval of seven biosimilars through October 2017, only three have come to market due to heated patent disputes and continued debate over biosimilar naming and interchangeability. Innovators maintain the need for distinct names to facilitate postmarket identification and tracking of safety issues for brand vs. follow-on therapies and...

www.pharmexec.com

 •  July 8, 2017

Value-based contracting is an umbrella term for the many different financial arrangements made more frequently between pharma manufacturers and payers. At a DIA session, Richard Gliklich, MD, CEO of OM1, defined Value as equal to Outcomes divided by Cost, with four major types of outcomes-based contracts. These include payment based on desired...

www.pharmexec.com

 •  February 14, 2017

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that biosimilars are suitable for substitution at the pharmacy level. The Generics and Biosimilars Initiative (GaBi) website reports that medicines deemed substitutable at the pharmacy level by the PBAC include a notation in the official Pharmaceutical Benefits Schedule...