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New survey research indicates that a country with a strong regulatory commitment for advancing drugs for rare diseases does better in getting orphan drugs to patients than countries with lesser regulatory frameworks.

The National Institute for Health and Care Excellence (NICE) will have a vital role in the post 2014 value-based pricing (VBP) world. The Department of Health (DH), which still acts as the sponsor organization for the agency, has set out in more detail just what value assessment by NICE will need to do. Now NICE has to determine the methods and set up the governance and workable processes to deliver it.

Publisher Russ Pratt on the Pharmaceutical Executive value proposition

The ink is not yet dry on the European Union’s Horizon 2020 agreement to invest some €70 billion ($92 bn) in research over the next seven years, and already contenders for funding are jostling for attention.

Pharma PE Ebook

Recently, there was a bit of a dust-up over whether it was appropriate for the Secretary of Health and Human Services (HHS) to engage the National Football League (NFL) to help HHS with the process of drumming-up enrollment for health insurance exchanges. In the end, the NFL and other sports leagues decided they were not going to be involved fearing the appearance of taking political sides.

I must be going soft. I actually caught myself feeling sorry for pharma marketers the other day.

Prescription abandonment-cited as one of the major cost-related issues in healthcare-has prompted numerous efforts to raise the profile of pharmacists in driving improvements in patient utilization.

Scientific opinion has special protection under the First Amendment, but does that give pharma a free pass to BYOD – build your own dataset – publish a peer-reviewed article based on the data, and then promote it for competitive advantage?

Not too many years ago, while employed by one of America’s leading Rx manufacturers, I remember stepping up to a retail drug store counter to pick up a prescription.

Joe Ganley, Director of State Government Affairs at McKesson, spoke earlier this year on public health policy and its implications for patient adherence. Here, he provides PharmExec with some highlights of that presentation.

PharmaFutures’ Pathways to Value: Pharma in a Changing World explains how the industry may move forward to combine business imperatives and social mandates through new strategies for determining value and reimbursement for medicines.

Click here to scan the metrics-including sales growth and gross margins-that PharmExec used to assess company performance and decide on this year's industry audit winner.

William Looney introduces this year's selection of 15 pharma professionals that, on our view, have real prospects for a future key to the C-suite.

Pharma and physicians worry about getting sunburned by the Sunshine Act.

Our lead feature this month on 15 new Emerging Pharma Leaders is a window into what makes our publication unique. In 2007, Pharm Exec began a systematic annual search to identify and highlight those men-and women-that in our purely editorial view had real prospects for a future key to the "c suite." Two of our early choices-Sanofi's Chris Viehbacher and Heather Bresch of Mylan-have made it to the very top, as CEO.

I read a blog post recently where Brian S. McGowan, PhD, predicted 50 percent of medical meetings will be replaced by virtual courses within five years. I don’t know about the number, but the logic is probably right. I’m sure a lot of CME can be delivered as well online as it can in person, possibly better.

The SupremJustice Sonia Sotomayore Court ruled last Monday in the case of Mutual Pharmaceuticals v. Bartlett that generic drug makers cannot change labeling or the formula of a drug after it has been approved by the FDA

That strict red line between regulatory authorization and market reimbursement is blurring pink – at least in Europe.

Pharmaceutical companies can anticipate more costly, drawn-out patent litigation in the wake of the June 17 US Supreme Court decision, which creates great uncertainty about the grounds for negotiating settlements in patent cases.

Tensions are rising in Europe’s pharmaceutical sector as crunch-time approaches for the legislation to combat counterfeits. By this time next year, the European Commission is due to have decided on the mechanisms required to put into effect the European Union’s hugely complex new rules to keep falsified medicines out of the legal supply chain. The manufacturing industry will have to carry the cost of much of the chosen system - and there is wide disagreement about what sort of system should be introduced, and who should pay for it.

On June 17, 2013 the Supreme Court decided FTC v. Actavis by a 5-3 vote. Justice Breyer delivered the majority opinion with Justices Kennedy, Ginsburg, Sotomayor and Kagan concurring.

Last week, the US Supreme Court issued a long-awaited decision in Myriad Genetics, which sent shockwaves through the very foundation of the biotech industry

Along with the details of an ambitious new organization restructuring and strategic product plan, Shire CEO Flemming Ornskov emphasizes talks about the importance of alignment with the customer and the untapped potential from Shire’s expertise in that sweet spot in specialty – rare diseases.

NHS England is currently undergoing profound changes to introduce a new culture where clinicians and patients are the new stars, where competition is mandatory, where everything rests on patient outcomes and where collaboration and innovation are being encouraged at the highest levels of command.

A common gripe from those in the pharma industry in England is that even when their products have been found to be cost effective by the National Institute for Health and Care Excellence (NICE) (not always easy to do these days), uptake in the NHS can be ‘low and slow’

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics. Although some commentators regarded the decision, Association for Molecular Pathology v. Myriad Genetics, as a “major reversal” in longstanding patent policy, many leaders of the biopharmaceutical research community described the ruling as likely to spur innovation and the development of therapies and companion diagnostics necessary for advances in personalized medicine.

Speakers at the 2nd annual Financial Times US Healthcare and Life Sciences conference in New York last week discussed the cost of health, and the implications of an increasingly vocal and influential stakeholder group: the local populace.