Guest Blogger

European regulation of pharmaceuticals has, since the foundation of the European Union around 60 years ago, been a story of medicines being controlled in a collaboration between regulators at the EU and national levels

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006.

Siegfried Schmitt offers some steps that manufacturing companies can take to ensure data integrity.

In this Applied Clinical Trials article, Kadmon CEO Dr. Sam Waksal talks about the importance of imagination for innovation, current business risks in biopharma, and applying understanding to the concept of Big Data.

As Europe departs for its annual holiday-sacrosanct, even amid the continuing economic woes, the multiple crises in the Middle East, and the dark mysteries of Russia’s intentions in its former satellites-the question remains unresolved as to what to expect from the new European Parliament in the new term.

Big Data and the mindset that comes with it will have a fundamental impact on how pharmaceutical research will be conducted in the future, writes Peter Tormay.

Over the years, healthcare professionals have needed to adapt to a more highly informed patient population due to improvements in the availability of accessible healthcare information through the internet.

With all of the buzz and excitement around risk-based monitoring (RBM), one might expect that the broad adoption of this emerging clinical research paradigm is well underway.

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects.

The European Union’s struggle to bring its data protection rules into the 21st century continues-haltingly-as the EU itself enters its new era, with a new European Parliament, a new President-designate of the European Commission, and a new European Commission due to take office in November.

The US healthcare system is expected to spend more than $150 billion treating cancer by 2020.

It is well known that Brazil has an immense biodiversity and that the Amazon is the largest tropical rainforest in the world.

The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.

The medical technology industry has a legacy of creating life-enhancing, life-extending products while rewarding its investors in the process.

The value of the customer relationship to a CMO is a function of two variables: unit volume and price per unit.

EvalutePharma’s seventh edition of its World Preview documents that worldwide prescription drug sales forecast will exceed the one trillion dollar mark by 2020.

Life sciences and biotech research clusters across the UK, including those linked to university research departments are benefiting from an improved funding climate and ongoing consolidation in the pharmaceutical sector.

Recruiting patients remains one of the most difficult challenges clinical trial sponsors face. Recognizing that fewer than five percent of eligible adult patients enroll in therapeutic trials.

Patients are influential in the UK when it comes to access to medicines: their individual stories are highlighted in the media and the groups that represent them are credited with major policies.

Currently, 66% of clinical trials are conducted in North America, Western Europe and Australia.

The Drug Information Association (DIA), one of the largest non-profit organizations supporting clinical research and drug development, held its 2014 annual meeting in San Diego last week. Applied Clinical Trials’ Moe Alsumidaie looks at three of the key themes from this year’s meeting: incorporating advocacy groups and patient voices in clinical research, breakthrough research applications, and new data collection methodologies.

Andy Bender and Geert van Gansewinkel outline eight lessons for executing a soft change program for enhancing compliance effectiveness within European life sciences organizations.

For pharma companies, entering the social media scene is not as simple as just creating a Facebook page or learning how to tweet in 140 characters or less.

Ahead of the BIO International Convention next week, Jim Greenwood, President and CEO of the Biotechnology Industry Organization, writes that protecting intellectual property rights is vital to biopharma innovation.

The major pressures hindering pharmaceutical industry success have not changed-payer constraints on drug costs, R&D productivity.

Brunei is harnessing its rich biodiversity and the growing halal market in a bid to develop its pharmaceutical sector.

Biopharmaceutical companies have traditionally considered outsourcing as a way to control costs and manage their internal resources to make the core activities left in-house more efficient.

The recent geopolitical developments in Ukraine have seriously influenced the conditions and the environment for clinical trials in Ukraine and in Russia.

Years ago, while sitting in an Rx company lunch room, I was listening to one of the company’s top sales reps discuss the commercial progress a recently launched prescription was making.

Speaking at the 2014 New York BIO conference, FDA Commissioner, Dr. Margaret Hamburg, addressed the pressing issues affecting the biopharmaceutical industry and the FDA