Regulatory

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

Radicals who wield real power at the EMA have gone public with their thinking about the role of regulators in the economic aspects of medicines provision – despite the decades-old EU taboo about linking pricing with authorizations.

There’s a stampede to relate prices to broader health benefits, but little consensus on how to do so, writes Jill Wechsler.

California is in the process of potentially establishing a new, disruptive healthcare policy that is proving to be very concerning to the American Rx industry, writes Tom Norton.

NHS England head Simon Stevens believes the UK's PPRS needs significantly updating.

We desperately need new anti-infective drugs to avoid life threatening infections. Let’s make that happen by punishing companies who don’t invest in R&D for these specific drugs.

Is a more "light-touch" appraisal process the key to getting the UK's NICE to do more with less? Leela Barham reports.

The dilemma continues: Which medicines should Europe's health systems pay for – and how much should they pay?

The Boston biotech cluster proved an ideal setting for Pharm Exec's recent annual Editorial Advisory Board meeting, with the prevailing message that even the best environments for innovation require constant nurturing.

Policymakers seek to limit prescribing while also encouraging innovative R&D.

The liver disease non-alcoholic steatohepatitis (NASH) has become a priority for the healthcare industry – and, potentially, a multi-billion-dollar market. The race is now to develop the first effective pharmacotherapy to treat it.

April 12, 2016.

The courts, pharma, and policymakers push FDA to rethink communications policy.

Just as insurers and regulators have sought to tamp down compounding costs and utilization, observers have begun to acknowledge that the practice may serve as an antidote to spiraling drug prices. John S. Linehan reports.

NICE's notion to charge the industry for its technology appraisals looks set to become reality, writes Leela Barham.

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

President Obama’s year-old, $200 million Precision Medicine initiative (PMI) seems to be doing exactly what was intended, writes Heather Gartman.

Clinical trials are challenging because pain is subjective, making it hard to define objective endpoints or to compare one drug to another.

Various factors have altered the landscape for exchange of information on drugs and medical products, but the FDA has not kept pace in updating its rules governing what marketers can say about their therapies, writes Jill Wechsler.

After eight years in development, FDA is looking to expand its Sentinel system to play a more visible role in assessing medical product efficacy, as well as safety.

Arvind Mani and Sherry O' Quinn outline the prevalence of private payer PLAs in Canada.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Valeant and Turing's fuzzy explanations of pricing practices to the House Oversight and Government Reform Committee cast a shadow over the broader industry, writes Jill Wechsler.

As that nation heads towards its first presidential primaries of the 2016 election, pharmaceutical executives should take a few minutes to consider where the leading candidates stand on U.S. Rx policy. Tom Norton takes a look.

It’s easy to foresee controversy in 2016 as lagging global economic growth and a messy US political slugfest force the pharma industry’s feet to the fire. Can the industry reclaim a semblance of public approval by confronting its pricing demons and focusing on innovation and a fresh, patient-first message?