Understanding the benefit-risk balance of medicines

07.30.13 | By

The assessment of benefits and risks is critical in the development of new medicines. Last year’s reauthorization of the Prescription Drug User Fee Act (PDUFA) included a new Patient-Focused Drug Development initiative at the Food and Drug Administration (FDA) to gain patient insight, including perspectives on the benefit-risk balance of medicines, in 20 disease states over five years.

Conversations Round-Up

07.30.13 | By

Every person is unique, and so are the challenges they face when it comes to their health. However, there are some core opportunities to improve care across wide swaths of the population, and that’s why we asked last week’s Conversations question: “What are the biggest challenges and opportunities when it comes to improving patient health?”

Answering the Call

07.25.13 | By

On Monday, the Personalized Medicine Coalition convened leaders from the field on Capitol Hill to discuss the promise of personalized medicine and the implications for policy-makers. A number of important issues were raised (more on that in my next post), but the highlight was remarks by Stephanie Haney. Stephanie is a lung cancer patient and mother of two who said she is alive today thanks to a novel personalized medicine.

Responsibly Sharing Clinical Research Results Will Enhance Scientific Knowledge and Advance Patient Care

07.24.13 | By

The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information.

New Trade Free Agreement

07.24.13 | By

Today, PhRMA President and CEO John Castellani testified before the House Energy and Commerce subcommittee on Commerce, Manufacturing and Trade about an ambitious new free trade agreement being negotiated between the United States and the European Union.

In Malaysia, Protecting IP Fosters Economic Growth

07.23.13 | By

This week, negotiators conclude the 18th round of Trans-Pacific Partnership (TPP) negotiations in Malaysia. The agreement, which includes Malaysia and 11 other nations, not only provides the United States with an entrée into the Asia Pacific region, but also opens new markets for all participating countries. But for this agreement to be beneficial globally, it must include strong intellectual property protections.

Patient Challenges and Opportunities

07.23.13 | By

The United States faces a growing number of health care challenges. Rates of chronic disease continue to climb, and by 2020, more than half the country is expected to suffer from a condition such as obesity, diabetes or chronic obstructive pulmonary disease (COPD) by 2020.

Rx Response

07.23.13 | By

Big storms – like Sandy, like Katrina – happen. The toll can be devastating.  Proper preparation to meet the human, logistical and supply-chain problems that come along with a big storm is critical.

'Conversations' Round Up

07.22.13 | By

Last week’s ‘Conversations’ question “What steps should the U.S. take to protect and strengthen IP rights domestically and overseas?” prompted interesting responses from the U.S.

Week in Review: Paving the Way for Innovative Medicines

07.19.13 | By

The biopharmaceutical community has made tremendous progress in recent years developing innovative treatments for chronic conditions, thanks to advancements in science and medicine.  Not only do these advancements improve people’s lives every day, they also provide hope that we may one day be able to prevent or cure diseases like Alzheimer’s, cancer and HIV/AIDS.  This week, the Catalys


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