The Bio Report

The market for Orphan drugs is growing at more than twice the rate of other prescription medicines In 2013, a record 260 therapeutics won orphan designations in the United States alone as science, policy, and pricing are fueling the trend for drugmakers to develop expensive drugs for small patient populations. We spoke to Jon Gardner, author of a new report from EvaluatePharma, about the growth of...

A new government report finds that healthcare providers in the United States are increasing their adoption of health information technology, but their willingness to do so is tied to the incentives available. What’s more, the government is implementing a new plan to improve interoperability, a suggestion that results from past efforts have fallen short of expectations. We spoke to Joe Smith, chief...

The National Science Foundation and the National Institutes of Health, concerned about seeing the science they fund commercialized, have embraced the Lean Startup method as a way to improve the odds of success for new companies. Steve Blank, whose work launched the Lean Startup movement, has long worked with entrepreneurs, but last year began working with life sciences startups to apply the approa...

There’s growing global concern about threat from antibiotic resistant pathogens. That’s leading to new interest in looking beyond traditional antibiotics to monoclonal antibodies to address the problem. We spoke to Ken Stover, senior director of infectious disease for MedImmune, about the problem, the role monoclonal antibodies could play, and why new efforts hold more promise than previous ones t...

Scientific breakthroughs, innovations in technology, and the changing use of data are among the forces that are driving disruptive changes to healthcare. A new report from the IMS Institute for Healthcare Informatics highlights a number of these developments and what they mean for the way healthcare is accessed and delivered. We spoke to Murray Aitken, executive director of the IMS Institute for H...

As pressure on government and corporate research budgets grow, organizations like the Multiple Myeloma Research Foundation are playing an increasingly critical role in advancing and accelerating drug development. The foundation’s efforts, including its landmark genetic study of multiple myeloma patients, are helping advance innovative therapies in an area that had long been characterized by its la...

There has been dramatic progress in the understanding and treatment of relapsing remitting multiple sclerosis, a debilitating neurodegenerative disorder. But progressive MS, a more advanced form of the disease, has remained elusive. Now, a novel collaboration has brought an international group of MS societies together to fund research. We spoke to Bruce Bebo, executive vice president of research f...

The U.S. Food and Drug Administration is moving to expand its regulatory domain by adding oversight of certain diagnostics it does not regulate today. The agency says thousands of these test are used daily to guide treatment decisions and diagnose disease, and it wants to ensure their validity and advance personalized medicine. We spoke to Nathan Beaver, a partner with Foley & Lardner, about the F...

One problem with drug discovery and development is that answers about the way substances act in the human body are often not apparent early in the process. Though human cell assays have been used, they have their limitations. BioSeek’s BioMap technology seeks to improve the success rate of research and development by bringing the complexity of human biology to cell assays and incorporating that in...

Drugmakers have employed new technologies to reduce the cost and time and it takes develop drugs and produce therapies that more precisely target the underlying biology driving diseases. Boston-based Berg Pharma is using artificial intelligence with a variety of other technologies to reengineer the discovery and development process. We spoke to Niven Narain, co-founder, president, and chief techno...

The biotech sector surged in the first half of the year despite volatile markets. M&A and financing continued to be robust as EvaluatePharma weighed in with its Pharma & Biotech Half-Year Report. We spoke to Jonathan Gardner, deputy news editor of EP Vantage, about the trends in the first half of the year, whether 2014 will set new records for M&A activity, and the threats out there that may put a...

The regulatory pathway for biosimilars is still a work in progress at the U.S. Food and Drug Administration, but around the world the industry is growing as regulators have resolved issues that remain obstacles in the United States. We spoke to Amit Munshi, CEO of Epirus Biopharmaceuticals, about the opportunities in emerging and developed markets, his company’s strategic approach, and when we’ll...