R&D/Clinical Trials

With the shadow cast by Mediator across Europe now receding to a focus on the French law courts, the European Union (EU) said in late November that its pharmacovigilance arrangements offer “one of the most advanced and comprehensive systems in the world”.

The Patient-Centered Outcomes Research Institute, or PCORI, announced last week that it will be granting a total of $12 million for up to 14 contracts for studies aimed at improving upon existing research methodologies to demonstrate clinical effectiveness.

Ideology, politics, and a stilted political debate may be causing pharma to overlook the potential of emerging stem cell therapies in fostering a new generation of cures.

There is much talk today about "open innovation" in business and research forums-but what exactly does it mean? How does open innovation as a concept apply to the pharmaceutical sector? Does it signal a change in the way pharmaceutical companies approach research and innovation?

Mastery of the clinical trial process has become essential to positioning new therapies for leadership in an increasingly crowded-and lengthy-race to registration.

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.

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.

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

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.