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On Friday, the New England Health Institute (NEHI), outlined six “Priorities for Action” to help steer the solution to better medication adherence in the US.

Being an observer rather than a participant in the drugs business makes it easier to sense those defining moments when something fundamental has changed, a limit is reached, and a new order emerges to reset the basic license to operate.

Insurance contracts are a language game that must be played very carefully, as AstraZeneca learned.

Pharm Exec’s sister organization CBI hosted its annual Orphan Drug Innovation Summit in Philadelphia on July 17-18. This is a topic that I have professional interest in, as well as a general curiosity.

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.

Pharmaceutical companies are awash in a sea of compliance regulations that affect their business operations both inside and outside the US.

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

With a revision of China’s basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation.

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.

What was once an obscure federal policy for providing low-cost drugs to safety-net hospitals has grown into a program that requires extensive discounting to one-third of the nation’s hospitals and health clinics. Pharma companies are pushing back, heightening tensions between “covered entities” that qualify for greatly reduced prices on medicines under 340B - and manufacturers that see the discounts making a big dent in U.S. revenues.

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?

With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies-particularly for rare diseases

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.

With the FDA striving to avoid post-market reactions to drugs with worrisome side-effect profiles, preventive measures that screen for obvious risks such as suicidal behavior and abuse potential are making their way into the lexicon of regulators and drug developers alike, in tandem with its mandate that stresses safety first and efficacy a close second.

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.