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Compliance rules under the US Physician Payments Sunshine Act have been criticized for the excruciating level of detail demanded from individual company submissions.

The data-transparency bandwagon is rolling rapidly across Europe, energetically propelled by regulators, health campaigners, and generic manufacturers.

In health care, it is the lowly consumer who is now calling the shots, driving product and process innovation in areas ranging from electronic medical records [EMR] to retail health clinics.

Writing last week on this blog, Beth Bengtson, principal at healthcare marketing and communications company Hale Advisors, highlighted the problem posed for public health by Wikipedia.

George Mina, Pfizer's Director/TL-Data Strategy & Reconciliation-Transparency Medical Division - External Medical Communications, on the challenges of implementing the Physician Payment Sunshine Act for pharmaceutical companies

An increasing number of small biotech companies are being hatched to focus on a single disease or condition. The strategy goes against the diversified portfolio approach most big pharma companies have embraced, and instead puts all the eggs in one basket.

Another temporary casualty of the US government shutdown is the negotiation process surrounding the US and Europe’s free trade agreement.

Officials from the Food and Drug Administration and the National Institutes of Health were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week.

The Multiple Myeloma Research Foundation (MMRF) has launched a new initiative to increase the pace of innovation in myeloma research through faster cures and more efficient, timely trials for patients

Predictive analysis has been used to great effect in the finance, tech, retail, and telecoms industries. Can it also improve decision-making and health outcomes in life sciences?

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).

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force.

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.