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Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown.

For more than three years, the US pharmaceutical industry has known that today would arrive. So this is it. The first day that eligible U.S. citizens can sign up for Obamacare - and enjoy the prospect of prescription drug insurance, effective January 1st, 2014.

Since the initial FDA approval of its flagship orphan drug Soliris in 2007, Alexion Pharmaceuticals has done well for itself as a small biotech firm that focuses on ultra-rare disease.

Doing deals with storytellers could be as important for pharma as collaborating with research scientists, writes Peter Houston.

Dr. Shantanu Agrawal, director of data sharing & partnership group and the medical director for the center for program integrity at CMS on the Physician Payment Sunshine Act

Europe’s closest thing to an Oscar’s ceremony for bioscience will take place in early October. The EuropaBio award for the most innovative European Union biotechnology firm is limited to firms with fewer than 250 staff or turnover or balance sheet of less than about $50 million.

Vaccines–once the neglected also ran in big Pharma’s armamentarium of innovations–received top billing at PhRMA’s annual Research and Hope awards held at the Washington Newseum on September 11.

Healthcare spending will rise modestly in the US over the next decade, as economic growth picks up, health reform provides expanded coverage, and the population continues to age, according to an annual analysis from the Centers for Medicare and Medicaid Services (CMS).

Paradigms change when questions emerge the old paradigm can no longer answer. Market access has become a buzz word as access to markets is as significant a hurdle to product usage as registration itself. I

It’s not just patients that have interesting marketing personas - HCPs have them too, writes Peter Houston.

The blurring of advertising and editorial content, particularly through publishers’ websites and mobile applications, is in the spotlight at the Federal Trade Commission (FTC) as government regulators struggle to deal with the impact of social media on health-related promotion.

Within the drug development services and life sciences industries, there is a common misconception held by many DIY marketers, in-house marketing teams and marketing agencies.

The shockwaves from the current European Union debates in Brussels on medical devices are likely to echo through the medicines business over the next few years.

The report analyzed data from several biopharmaceutical and medical device clinical trials, and emphasized several observations

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.

With the pharma industry spending over $31 billion a year on product promotion, the melding of ad giants Omnicom and Publicis beckons a closer look.

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?