Regulatory

The US and EU move forward with measures to fortify the pharmaceutical supply chain, writes Patricia Van Arnum.

FDA wants pharma leaders to do more to ensure drug quality at home and abroad. Our Washington correspondent Jill Wechsler reports.

What is really driving decision making by the new Brazilian HTA agency? A look at appraisals issued in the first year.

Compounders are under increased scrutiny following last year's spinal meningitis outbreak.

While not as bleak as believed, the outlook of European biotech sector is struggling compared with its US counterpart.

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

Value-based pricing in the United Kingdom is getting closer, but it remains out of focus.

Legal battles and regulatory missteps undermine access to low-cost generics, at home and abroad, writes Jill Wechsler.

The European Union's attempt to update its transparency rules sparks new debate.

There seems no end to demands for data on clinical research, conflicts of interest, company payments, and drug prices.

European Commision blocks the authorization of a life-saving liver drug outside of France.

After a decade of strife, the dialogue between industry and government appears to have entered a positive new phase. Julian Upton reports.

Compliance officers have risen into management's highest ranks, by choice in some organizations, and by government decree in others. Either way, their importance as a strategic partner can hardly be understated.

FDA policies will reshape drug development, while pressure to cut healthcare spending may alter drug coverage and pricing.

If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).

Increased scrutiny and new regulation have seen pharma’s relationship with key opinion leaders (KOLs) undergo a paradigm shift in recent years.

Tax and budget decisions will shape the healthcare market and drug research and regulation.

At two years and counting, what's the secret of success in negotiating pricing under the new AMNOG legislation?

Europe's chief regulator charts a strategy from many moving parts. Dr Guido Rasi talks to Pharm Exec's William Looney.

Recent change likely to boost drug coverage by plans, but with variation in formularies.

Over-the-counter products face a new wave of regulation.

It was in 1984 when FDA first added the 505(b)(2) pathway for drug approval, a hybrid between the accelerated pathway for generic drug applications, and the standard de novo NDA pathway for proprietary drugs.

With the Supreme Court’s decision in June to uphold the Patient Protection and Affordable Care Act (ACA), life science companies gained access to 32 million potential new customers.

The new head of EFPIA faces a Promethean challenge: selling the merits of costly science and innovation in an era of bristling competition, fiscal crisis, and declining demographics.

The most obvious competitors for Sanofi’s Aubagio, the second oral multiple sclerosis (MS) drug to receive FDA approval, would appear to be Novartis’ Gilenya.