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KOLs have traditionally exerted their influence through research and publication on drug safety and efficacy, but now share the stage with other important measures.

Patient preferences are increasingly seen as valuable in healthcare policy decision-making, but such studies are not always easy to design and implement, writes Nick Hicks.

The discrepancies between trial and real-life patient conditions are such that Real-World Evidence (RWE) can be utilized to supplement this process.

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

As part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.

We’re about to lose the most tech-savvy FDA chief in recent memory, writes Pratap Khedkar.

Brenda Snow talks to Pharm Exec about the creation of Snow Companies, the first full-service agency to bring strategic, regulatory-compliant, real-life patient stories to direct-to-patient initiatives.

Click the title above to open the Pharmaceutical Executive March 2019 issue in an interactive PDF format.

After a prolonged period of relative stagnation, the strategically influential, clinically rich French life sciences market suddenly seems to be rediscovering its mojo-thrusting the pharma and medtech sectors into the spotlight.

Purdue Pharma and its corporate leadership featured prominently in the media recently as litigation mounts over their sales and marketing of Oxycontin. Nir Kossovsky offers some observations about the lessons this situation provides for all corporate leaders responsible for their companies’ reputations.

New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.

Click the title above to open the Pharmaceutical Executive February 2019 issue in an interactive PDF format.

With Spain now squarely on the road to economic recovery following the ravages of the global financial crisis, multinational pharmaceutical companies are seeing the country as a top-tier investment destination once more.

The Institute for Clinical Effectiveness Review (ICER) has set up a working group to bring together the expertise of NICE and other key HTAs to develop new methods to guide value-based pricing of potential cures. Leela Barham reports.

DIA Europe proves to have excellent timing to learn more about the latest developments in drug development, the current status of Brexit, the plans of the National regulators and EMA, on-going discussions on pan-European HTA, and the trends for 2019.