Regulatory

Zika vaccine development is hindered by technical challenges and funding shortfalls, writes Jill Wechsler.

Could the new Vermont Drug Transparency law “lead the US Pharmaceutical industry to an awful end”? Tom Norton reports.

The lines between the pharma and food industries are blurring, presenting a great opportunity for life sciences firms to diversify - as long as they understand the regulatory differences, writes Peter Muller.

Leela Barham looks at the EU plans for a European patent, and asks where the UK will fit in after Brexit.

Stakeholders are looking to move up the Prescription Drug User Fee Act timeframe to gain Congressional action before the Obama administration steps down.

Not yet, says Reflector. But to judge from the European Parliament's latest foray into the subject, there could be plenty of support for such an approach to this complicated subject.

A look at how Europe's new accelerated drug approval scheme can evolve existing review pathways for the better-and take a page from FDA

The UK's Brexit vote has unleashed turbulence in Europe - not least on its pharma sector. Reflector reports.

FDA's Brenda Stodart outlines the services of the Agency's Small Business and Industry Assistance (SBIA) Program.

Highly skilled pharma staff are obliged to devote hours to routine administrative tasks updating product information. Technology can free them from this burden, writes Dr. Jutta Hohenhörst.

Rapid growth in Medicare spending on prescription drugs is prompting a leading advisory group to recommend significant revisions in how the government pays for medicines under Part D and Part B

Despite enthusiasm from payers and pharma companies for innovative drug reimbursement strategies linked to positive patient responses, negotiating such deals is no easy business.

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

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.