FDA

Pharma has been quick to take up its share of social media — companies have already staked out their space on Facebook, Twitter and even Pinterest.  Television ad spending is down as drug companies have increased their use of these new platforms to interact...

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion...

Pharmaceutical companies may not take the Hippocratic Oath, but, through dedicated pharmacovigilance programs, companies ensure that drug safety remains a top priority among their medical affairs responsibilities.  Within companies’ medical affairs teams, evaluating...

If you’re looking for reasons to expedite drug research and approval processes, you need look no further than oncology departments in hospitals around the country.  The need in these facilities for cutting-edge therapies is critical, and doctors are performing...

Many small pharmaceutical companies and biotech manufacturers continue to struggle with FDA approval delays that have developed over the past several years. Even internationally, regulatory guidelines have evolved to the point of being outright onerous in some...

By Ryan McGuire, Senior Research Analyst If you received a memo recently from your compliance group detailing a new standard operating procedure, then chances are your company is using increasingly outmoded training tools. Online compliance training...

By Casey Ferrell, Senior Research Analyst In sports, payroll tends to have a big impact on the quality of a roster. Though it doesn't always equate to Stanley Cups or World Series rings, the rule is pretty simple: more money equals better players equals...

By Elio Evangelista, Director of Research The United States is still waiting for the Centers for Medicare and Medicaid Services (CMS) to issue its final ruling on how it will implement the disclosure rules outlined in the Physician Payments Sunshine...

By Elio Evangelista, Director of Research The promise of adaptive clinical trials leading to significant cost savings is attractive, and many drug companies have already put the strategy into practice. But most times, companies implement adaptive clinical...

By Ryan McGuire,Senior Research Analyst The megatrend of personalized medicine gained a significant boost of adrenaline recently as Vertex Pharmaceutical's cystic fibrosis drug, Kalydeco (ivacaftor), earned FDA approval. As with much of personalized medicine's...