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We’re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market

With announcements pouring in since the beginning of this year, FDA’s fourth and newest expedited approval pathway for medicines has begun to bear fruit. Established in 2012 within the FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designations have so far totaled 25 as of the end of July.

In the spirit of lawn chair cogitation and hammock-spun reverie, Pharm Exec invites you to submit your own verses-pharma-related, of course-to be published on our website in late August.

The trade media is ablaze with lurid accounts of bribery, tax fraud, and other illicit promotional activities in China-ironically, the country touted as guarantor of our industry's future.

Eight months into the launch of its first approved drug – Iclusig (ponatinib), a small molecule therapy indicated for two rare forms of leukemia – Ariad Pharmaceuticals’ principal founder and CEO Harvey Berger says doing it all, from discovery to global commercialization, is the company’s path to sustainability and the way to take on Big Pharma.

The value of retrospective studies cannot be overstated. Retrospective studies affect many healthcare sectors, including the pharmaceutical industry and general public health

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.