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Large Drug Firms' Buys Of Smaller Ones Seen As Factor In Drug Price Hikes

Some drug price-control advocates say recent moves by big pharmaceutical companies to buy smaller biotechnology companies that have developed specialty drugs are contributing to rising drug costs and a lack of transparency around how those drugs are priced -- though others say such a business model has been common for years, and the recent high-profile acquisitions by Roche and Gilead Sciences simply serve to highlight this model.

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Legal experts say Congress should give FDA new power to respond to shortages of critical drugs, floating the ideas of letting FDA temporarily re-purpose a drug license to another company, akin to NIH's march-in rights, and allowing importation from unregistered foreign manufacturers.

The HHS Office of Inspector General has uncovered several vulnerabilities in FDA's computer network, including error messages revealing sensitive system information and lack of assessments on all external servers, that it warns could lead to unauthorized disclosure of FDA data and mission-critical systems being made unavailable.

The healthcare sector should emulate other critical infrastructure sectors on cybersecurity, but should also nail down unique aspects to healthcare and medical device cybersecurity, government and industry officials said at an event hosted by FDA.

Karen DeSalvo is leaving her position as National Coordinator for Health Information Technology to take up the role as acting assistant secretary for health, the Office of the National Coordinator said Thursday (Oct. 23), less than a year after she stepped into the role.

CANBERRA -- U.S. brand-name drug companies are taking the position that they will only support a Trans-Pacific Partnership (TPP) agreement that includes a time-based transition period for implementing intellectual property (IP) obligations rather than one linked to development indicators, but are willing to be flexible on their demand for 12 years of data exclusivity for biologic drugs, according to industry sources.

CMS unveiled a new Transforming Clinical Practice Initiative, which will create networks to help providers adapt and develop quality improvement strategies, on Thursday (Oct. 23) to the delight of the American Medical Association and other physician groups.

A group of nearly 1,200 stakeholders, including hospitals, physicians and families advocates, are urging congressional leaders to take up legislation during the lame duck session that would extend the Children's Health Insurance Program, which is slated to lose funding after Sept. 30, 2015, for an additional four years.

The European Generic Medicines Association is urging the World Health Organization not to pursue its biological qualifier naming scheme unless it generates different options, discusses them publicly and sets up an independent user-test of the different possibilities, according to a summary of the group's stance conveyed to WHO last week.