Genetic Alliance Pilot to Advance Patient-Focused Drug Development

01.28.14 | By

When considering the benefits and risks of medicines, patients provide a unique perspective of unparalleled value.  A deep understanding of the patient perspective on benefits and risks throughout the drug development process has the potential to significantly advance the biopharmaceutical industry’s efforts to bring to patients new medicines that extend and improve the quality of their lives.  

Outdated Regulatory Framework Hinders Exchange of Information in Healthcare System

01.28.14 | By

Before the holidays, PhRMA’s General Counsel Mit Spears wrote a post in The Catalyst about the need for a new regulatory paradigm to govern how the biopharmaceutical industry communicates with healthcare professionals about the medicines that our companies research and develop.

Addressing Challenges in Rare Disease Drug Development - Together

01.27.14 | By

Dr. Richard Moscicki, Deputy Center Director for Science Operations at the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), noted in his remarks at the FDA public workshop on Complex Issues in Developing Drug and Biological Products for Rare Diseases held earlier this month that more than a third of the novel drugs approved in CY13 treat rare disease.

Several Important Pieces of the R&D Puzzle

01.17.14 | By

Like a complex puzzle, the research and development (R&D) process for new medicines requires many pieces to work concurrently to ensure success. From the patients who inspire us to the experts behind the research, every part is critical to a prosperous pipeline for patients suffering from some of the world’s most debilitating diseases.

A New Window Into the Lives of Biopharmaceutical Scientists

01.17.14 | By

As we continue our discussion of STEM education this week, we’re providing a window into the daily lives of some of our member companies’ biopharmaceutical researchers and getting their advice for future STEM educated individuals in our “I am Research, Progress, Hope” series.

Rare Disease Community Loses a Champion

01.15.14 | By

The rare disease community lost a champion last week when Sam Berns passed away at age 17 due to complications from progeria, an extremely rare genetic disease which causes accelerated aging. Last October, Sam shared his inspiring philosophy for a happy life in his talk at TEDxMidAtlantic.

PhRMA Statement on Release of Sequestered FY2013 PDUFA Fees in Omnibus Spending Package

WASHINGTON, D.C. (January 14, 2014) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Scientific and Regulatory Affairs Sascha Haverfield, PhD, issued the following statement on the release of sequestered prescription drug user fees included in the omnibus spending package filed yesterday:

Understanding Patient Perspective Critical in Benefit-Risk Assessment

01.06.14 | By

The assessment of the benefit-risk balance of a medicine is a key component of the drug development and regulatory review process. This assessment is also an important determination that each patient and doctor must make when choosing a treatment strategy.

Upholding Ethical Standards

12.28.13 | By

The best health stems from the best information, and this includes biopharmaceutical information-sharing with physicians and patients. As the creators of many of the medicines we all rely upon, the companies have the most up to date knowledge on safety and benefit/risk, making conversations with prescribing physicians imperative to better care.

TPP and Intellectual Property

12.20.13 | By

What provides two-thirds of the Trans-Pacific Partnership (TPP) agreement’s total economic benefits? The answer is intellectual property-intensive manufacturing industries.


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