Commitment to Data Sharing

01.30.14 | By

As of January 1, researchers are now able to submit proposals to receive access to patient level data, protocols, and clinical study reports for new medicines approved in the U.S and EU after January 1, 2014.  The biopharmaceutical sector’s commitment to data sharing provides new avenues for the scientific community and patients to benefit from clinical research, while maintaining patient privacy, the integrity of national regulators, and incentives for companies to make long-term investments in biomedical research.
 

On Pharmaceutical Innovation, Intellectual Property Rights, Patient Access and Pricing

01.30.14 | By

Dr. Robert Freeman, Professor of Pharmacy Administration (health services research) in the Department of Pharmacy Practice & Administration at the University of Maryland Eastern Shore School of Pharmacy, comments on the recently released paper from University College London School of Pharmacy on patient’s needs and intellectual property in middle income countries.

PhRMA on the State of the Union Address

Washington, D.C. (January 29, 2014) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani issued the following statement:

"President Obama’s address comes at a time when America’s biopharmaceutical research companies are bringing pioneering new medicines to patients, supporting high-value American jobs and helping strengthen local communities and our national economy. Continued progress – the kind that President Obama urged for last night – is only possible, however, if we fully embrace innovation.

I am Research, Progress, Hope: It Takes a Team

01.29.14 | By

Today’s featured scientist comes from Agensys, a subsidiary of Astellas, where she is working on developing a treatment or cure for different types of cancers.

Looking Past 'Can vs. Can’t'

01.28.14 | By

The great inventor and businessman Henry Ford once said, “Whether you think you can, or think you can’t – you’re right."

Getting the Facts on Cost of Medicines

01.28.14 | By

When looking at an issue as important and complex as health care costs in the U.S., it’s critical that full facts, not select data, lead the discussion. Drew Armstrong’s recent article about a Hepatitis C medicine paints an incomplete picture of our health care system and further propels inaccurate information about prescription medicines.

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.

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