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At the end of this month, the European Medicines Agency will close the consultation on its draft policy on Publication and access to clinical-trial data. The aim of the policy is laudable: to open up as much information as possible into the public domain with the aim of stimulating new avenues of research.

Post Exubera, inhaled insulin has been an uphill struggle with regulators.

We are now less than three weeks away from the initial sign up period for Obamacare. After October 1st, the reality of the program and all that it portends for the future of the US pharmaceutical industry will begin to make itself apparent

Smartwatches need health data to matter, writes Peter Houston.

Since the Omnicom-Publicis merger was announced in late July, it appears the only sources that have not commented on the joining of the superpowers are the President, the Pope, and WikiLeaks.

A key issue for biopharma marketers today is balancing cost and value factors around specialty biologic drugs, particularly those for cancer and other high profile, lifealtering diseases.

Go to any communications seminar, forum, convention or workshop right now and the program will be populated with the latest and greatest trends in social communication platforms and how important these are if you want to be successful

On Café Pharma message boards, the drug industry’s online water cooler, anonymous sales reps are sounding off on the Physician Payment Sunshine Act and its implications for their battered profession.

Novo Nordisk’s SVP of national diabetes sales speaks with PharmExec about a new field force technology initiative, implications of the Sunshine Act, and why Victoza sales won’t slow down anytime soon.

A key issue for biopharma marketers today is balancing cost and value factors around specialty biologic drugs, particularly those for cancer and other high profile, life-altering diseases.

What does it take for internal Promotional Review Committees to function at their best and avoid costly mistakes to the company? A leading industry practitioner offers 15 tips for high performing teams.

As the process to create the Transatlantic Trade and Investment Partnership (T-TIP) gets underway, Reflector asks, what is the likelihood of drug firms - and patients - reaping any rewards from the negotiations?

Earlier this week, the federal government’s Patient Centered Outcomes Research Institute (PCORI) unveiled a new survey, revealing that both patients and clinicians want in health research to focus on one thing: improving outcomes

Editorial Director William Looney discusses the five essential characteristics exhibited by the more than 200 men and women selected by Pharmaceutical Executive as Emerging Pharma Leaders

As many of you may recall, earlier this year I commented on a section of the new Obamacare law that directed Members of Congress and their staffs to participate in the new healthcare program, effective January 1, 2014.

Roche tmpphis week has announced a partnership with the UN-backed Medicines Patent Pool (MPP) to provide its drug valganciclovir, better known in the developed world as Valcyte, in 138 countries for a reduced price.

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.

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.

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.

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.