If it looks like a medical device and it works like a medical device, it’s probably a medical device.
App developers, the wait is over! The FDA has finally released its guidance on mobile medical applications. The guidance describes the types of apps that are covered under FDA oversight and those left to the discretion of app developers. Continue reading
Pharmaceutical companies are evolving their advisory board strategies to keep pace with the rapid changes that the entire industry is experiencing. As payer demands increase in complexity, the importance of engaging payers to understand their needs is growing. The depth of outcomes data that payers need requires precisely targeted clinical trials to be effectively developed to meet these needs. As such, when a team is able to gather a roomful of experts together, the benefits from that time need to be maximized for both the participants’ and the company’s sake. One significant — and relatively simple — step that companies can take is to ensure that the moderator or co-chair is up to the task. Continue reading
Generations of hopeful party planners and anxious hostesses have turned to Emily Post as the authority on all things etiquette. Her gentle but firm guidelines on manners and social norms may seem more appropriate for old-fashioned ladies throwing summer soirees or bridal luncheons than they do for high-powered life science industry executives who are delving into the latest clinical research or marketing strategies. Although pharmaceutical companies specialize in developing innovative cures, looking back to the traditional truths of hosting etiquette lends value to advisory boards. Here is a look at successful pharmaceutical advisory board management through the lens of the Emily Post Institute’s Six Ways to Be a Good Host. Continue reading
Pesky mosquitoes have forced an early end to many swampy summer nights. But these parasites pose a much greater risk for the nearly 200 million people infected with malaria each year. In a small Phase 1 clinical trial, a potential vaccine demonstrated encouraging results. PfSPZ was highly effective in patients receiving the highest dose. Developed by biotechnology firm Sanaria, the vaccine is in early testing stages. Although the results are promising, they need to be replicated on a bigger scale and evaluated over time to determine how long the protection lasts. Continue reading
The key to weight loss is to burn more calories than you consume. Most weight-loss drugs facilitate this process by curbing their patients’ appetites as they diet and exercise. But what if there were a drug that increased caloric burn without making a patient eat less? Continue reading
In today’s global market, life science companies worldwide face challenges such as increased austerity measures, unfamiliar emerging markets payers and governments, greater emphasis on health economics and regulatory reforms.
To address these challenges, many companies are turning to integrated teams that include health economics, comparative effectiveness research and market access alongside pricing functions. The added focus to develop a presence in emerging markets creates new pricing challenges, especially when facing an unfamiliar market with unique regulatory and access issues. Continue reading
In 2012, many key drugs in the US fell off the patent cliff and lost their market exclusivity. As US pharmaceutical companies watched these products meet their fates, they tried their best to mitigate the damage. Some companies have decreased reliance on blockbuster drugs by diversifying their pipelines. Others have looked to mergers or entered the generics market themselves. In the end, however, most companies had to simply brace themselves and cut their losses. For market access, these methods resulted in decreased budgets for 2012. Continue reading
With the expanding emphasis on building payer relationships and demonstrating product value, health outcomes liaison and managed care liaison teams are more important than ever. The first step to building a strong payer liaison team is to find the right HOL candidate. However, finding these candidates is difficult due to the unique combination of skills necessary to this role. Companies must focus on the right blend of education, experience and training to ensure they have a strong payer liaison team. Continue reading
Regulatory affairs groups in the pharmaceutical industry have been going through a fast-paced evolution over the past 10 years. It wasn’t that long ago that these groups were almost taken for granted in the industry. Recently, however, this role has been changing substantially from simply getting a drug approved to being involved much earlier in the development process and asked to significantly influence the final product. Continue reading
With the rise of social media and mobile technology worldwide, it was only a matter of time until industries turned to social intelligence for market insight. Big Pharma is typically a latecomer to the social arena, lagging behind other industries that face less-restrictive requirements. However, the promise of Big Data and the prospect of reality mining and social analytics have more and more companies looking to the web. Continue reading