Pharmaceutical Executive-09-01-2015

The Alliance for Clinical Research Excellence and Safety (ACRES) is advocating a “systems thinking” approach in efforts to meet increasing demands to standardize and integrate support for trial sites.

After a sharp spike in revenues, this year’s audit finds our 25 companies doubling down to secure the operational efficiencies that promise to better align with an increasingly tightfisted payer community. Never before has market relevance been so firmly linked to customer reputation.

Tighter public scrutiny combined with tough new standards for clinical testing and regulatory approval of foreign medicines are clouding future revenue projections for multinational drugmakers in China. But this also represents an opportunity-if companies adopt a forward-looking approach based on close internal cross-functional collaboration and coordinated outreach to the locals that count.

Where is US payer formulary management heading-and what can the industry do to help influence its course?

On June 30, the Centers for Medicare and Medicaid Services (CMS) released the first full year of data under The Affordable Care Act’s transparency program, also known as Open Payments or the "Sunshine Act." This included approximately 11.4 million records totaling about $6.5 billion in payments made to 607,000 physicians and 1,121 teaching hospitals by 1,444 reporting entities during 2014. Combined with CMS’s September 2014 release of 2013 data for the period Aug. 1, 2013 through Dec.

Amarin ruling puts pressure on FDA to re-assess marketing rules

The age of genomics is giving rise to highly specialized diagnostic tools, targeted therapies, and personalized drug monitoring. This new generation of individualized treatments will require life sciences companies to evolve how they reach and educate the healthcare community. Are your commercial operations up to the task?

Measurement is a given in the pharmaceutical industry: dosage charts, chemistry formulas, budgets for testing, and budgets to go to market. When it comes to marketing, particularly through social media channels, measurement of return on investment (ROI) poses its own set of challenges. 

A closer look at our Industry Audit numbers hints to a clear divide between two alternative strategies for long-term growth: scale versus focus.

Three key questions dominate the agency’s Breakthrough Therapy Designation program since its 2012 launch.

Free speech ruling, social media flap, and "female Viagra" highlight busy month for agency.

Pharm Exec sits down with prominent biotech investment strategist, Tony Gibney, to better gauge today’s state of play in this critically innovative segment of the life sciences industry.

France is a striking example of why Europe is still only "edging towards" a genuine universal system

Plans and policies are in place to leverage the pharma industry as an integral force in transforming Mexico from a predominantly manufacturing-based economy to one driven more by innovation.