Ethics/Regulatory

Upcoming EU referendum delays UK pharma market changes

Monday, April 18, 2016

Civil servants must observe a period of “purdah” in the weeks before a general election or referendum, which restricts government activity to avoid unfairly influencing public opinion. This has hit two major consultations for the pharma industry—the Accelerated Access Review (AAR) and proposed changes to the medicines pricing system known as the Statutory Scheme. The AAR is the brainchild of life sciences minister George Freeman, who wants it to re-shape the U.K. market and the National Health Service (NHS) around encouraging medical innovation, and remove some of the blocks and bottlenecks which plague the current system.

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Study: U.S. drug spending growth reaches 8.5% in 2015

Monday, April 18, 2016

Total spending on medicines in the U.S. reached $310 billion in 2015 on an estimated net price basis, up 8.5% from the previous year, according to a new report issued by the IMS Institute for Healthcare Informatics. The surge of new medicines remained strong last year and demand for recently launched brands maintained historically high levels. The savings from branded medicines facing generic competition were relatively low in 2015, and the impact of price increases on brands was limited due to higher rebates and price concessions from manufacturers. Specialty dug spending reached $121 billion on a net price basis, up more than 15% from 2014.

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Analysis: U.S. Ranks 1st in national impact on global biopharma innovation policies

Wednesday, April 13, 2016

The U.S. ranks 1st in how its domestic policies support worldwide life sciences innovation, according to an analysis released by the Information Technology and Innovation Foundation (ITIF), a global technology policy think tank. Released on World Health Day, the findings come in a new report assessing 56 countries—which together comprise close to 90% of the world’s economy—on the extent to which their scientific research, drug pricing, and intellectual property policies contribute to global biopharmaceutical innovation.

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Watchdog group files amendment to FDA Citizen Petition

Wednesday, March 30, 2016

With deaths in clinical drug trials every month since December 2015, Center for Responsible Science (CRS) has updated its July 2015 citizen petition. The petition urges the FDA to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing. Current regulations mandate the use of animal models, despite great progress in more human relevant tests.

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FDA releases enhanced warnings for immediate-release opioid pain medications

Wednesday, March 23, 2016

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the FDA has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. These actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

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EMA launches PRIME for unmet medical need medicines

Monday, March 7, 2016

The EMA has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

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