Regulatory

More new medicines gained market approval in 2012, but marketers face resistance from payers looking to cut healthcare spending, writes Jill Wechsler.

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.

The calendar says its wrap-up time, not just for gifts but for some of the trends that shaped the industry-for good or bad-in 2012.

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.

Last Tuesday, HHS proposed regulations that, most notably, shed light on one of ACA’s centerpieces: gutting the insurance industry’s ability to limit coverage based on pre-existing conditions, and establishing new criteria for evaluating eligibility.

While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives, writes Jill Wechsler.

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.

The call for stiffer FDA regulation of compounded drugs has been reignited by a national fungal meningitis outbreak.

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.

The Senate Special Committee on Aging is holding a Roundtable discussion on Wed. Sept. 12.

Europe's fiscal crisis is becoming a new rallying cry for patient groups-but regional unity is still elusive.

Bending the cost curve back to valuing the cycle of life.

Well, we certainly have a presidential campaign now, don’t we? Good grief. Since Rep. Paul Ryan was named the Republican VP candidate last week.

Big Pharma talks a lot about changing its business model to one that prioritizes quality and value over quantity and waste. While the healthcare "ecosystem" waits for pharma to grow into this model, government is delivering a comeuppance that actually puts it in the driver's seat and gaining the upper hand.

Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies. Jill Wechsler reports.

It’s back to business for pharma and biotech companies. The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the U.S. healthcare system.

So, it looks like June 25th will be the moment of truth we have all been anticipating. The Supreme Court is expected to hand down its ruling on the 2010 healthcare reform law. Who knows what will happen?

Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans. House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support Food and Drug Administration regulatory programs.

A recent medical device controversy in France has pushed European health ministers to agree on a crisis management program for the troubled sector.

No matter how the Supreme Court rules on healthcare reform, the accountable care model will stick around. To play ball with ACOs, drug companies will need to throw a different pitch.

A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.