R&D/Clinical Trials

As brands are required to produce more and more data to convince not only regulators, but payers, physicians, and patients, Jeffrey Jonas is pushing Shire's "search and develop" R&D model into new and sometimes uncomfortable territory.

Poland's government is aiming to make the Eastern European country a biotech powerhouse.

To gain market access in emerging markets, pharma companies face pressure to offer a convincing Corporate Value Proposition to governments.

The quest for 'radical' R&D innovation is often pursued at the expense of treatments with hidden blockbuster potential, writes Bert Spilker.

After his predecessor and countryman left the EMA in disgrace, Guido Rasi jumps in as executive director-with great challenges ahead.

Sponsor sourcing requirements are diverging from the operating needs and long-term strategies of the major CROs.

A new generation of products for inflammatory disease is coming forward, promising better promise and possibly a cure.

Henry Waxman, Congressional Representative from Los Angeles, California

The rise of advocacy groups has helped patients find their voice, but the power to change health profiles remains an elusive goal.

Henry Grabowski, PhD, Professor of Economics, Duke University

Observational studies present a compelling real-world corollary to the classic randomized clinical trial.

In medicines, as in life, the journey is just as important as the end result

Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game

Find out how pharma can find new drug candidates and refill the pipeline in this episode of Pharma Faceoff. Watch now.

The payoff is superior performance in key areas such as clinical trials

The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency

All this uncertainty at the back end of drug development is a drain on future therapeutic progress against disease. It's a job killer, too.

42 of the best new drugs in development–or parked at the FDA

Tracking, monitoring, and trend evaluation is not enough. Companies must now do more than assess what happened and why.

Innovating in R&D may not be such a complicated task. Consumers simply want to find the product that gets a job done right every time

A new leader, a big acquisition, and a bold investment in HIV may all be in the works at Gilead. But what will it take to restore the glory days?

Industry needs to engage in a broader public debate on ways to rekindle the innovative engine in new drug discovery and development

Pfizer's VP and Assistant General Counsel for Global Patents and Policy, Roy Waldron, discusses its collaborative strategy to refresh the face of IP

Professor Bill Trombetta takes a snapshot of the "Glamour 24" companies shaping the pharma industry this year and beyond

The European Generic Medicines Association's Director for Scientific Affairs, Suzette Cox, talks to us about the environment for biosimilars.

May 24, 2010.

Re-examining service provider roles can bring safety and speed on the road to registration.

Cognitive enhancement is a $20 billion market of aging Boomers, cramming students, global travelers, and battling soldiers. What's pharma going to do about it.

Several leading pharmas may already have a drug for a retrovirus linked to chronic fatigue disease. Has medicine's "problem child" finally earned the industry's respect?

How proper site activation and site enrollment can help you get the most from clinical trials.