Regulatory

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.

Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure.

Switching Rx drugs to OTC and adding comparative data could broaden access to treatment, writes Jill Wechsler.

To gain market access in emerging markets, pharma companies face pressure to offer a convincing Corporate Value Proposition to governments.

The Supreme Court's Decision on whether pharma sales reps should qualify for the 'outside sales exemption' could have far reaching implications, write Lisa A. Schreter and Kimberly J. Gost.

Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors.

While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help.

How can we better balance addressing medical needs with ensuring that new drugs are safe and effective? Ron Cohen reports.

Our annual press audit finds that the big news in 2011 for pharma was ... no news.