Regulatory

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 long planned for transparency of industry payments to doctors, pharmacists, nurses and others has shone some dappled light on the UK industry, writes Leela Barham.

It's time for new pharma strategies to combat deadly drug-resistant infections, writes Jil Wechsler.

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

Leela Barham looks at the implications for the UK industry in the aftermath of last week's vote for Brexit.

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.

Eleanor Biggs looks at the biggest uncertainties facing the pharma industry if the UK were to leave the EU.

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.

Pharm Exec’s 10th annual Brand of the Year is Bristol-Myers Squibb’s Opdivo, which has raced into the lead position in the treatment-shifting immuno-oncology space behind launches in three key cancers-melanoma, lung, and renal.

Election-year activities may stall the passage of biomedical innovation bill in 2016.

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.

Despite research by eminent scientists as to the safety and benefits of immunization for children and adults, the anti-vaccine film "Vaxxed: From Cover-Up to Catastrophe” has all the emotional elements to convince millions that vaccines are unsafe and dangerous, writes Jill Wechsler.