Is Pharmaceutical Collaboration an Oxymoron?

With the rise of combination therapy – the use drugs with different mechanisms of action to combat a specific disease state – comes the need to address medical costs and reimbursement issues.  Joint negotiation of package deals with government and health...

Personalized Medicine: Friend or Foe?

For pharmaceutical companies, is personalized medicine more of a threat than an opportunity?  In addition to the development of new drugs, genetic information can also help target the use of current medications (e.g., Plavix).  The use of genetic (or other)...

Advantages of Incremental Innovation in Drug Development

Ideally, every new drug would represent an unprecedented breakthrough and lead to the creation of a completely novel treatment. This, however, is not the reality of the pharmaceutical industry, or of any other development-based industry. Creating drugs based on...

Orphan Drug Development: Midsize to Large Company Perspectives

Rare diseases can be described in terms of incidence, etiology, morbidity, and survival.  Incidence can vary, however, from rare (e.g., Gaucher disease, cystic fibrosis) to epidemic proportions (e.g., HIV, malaria, cholera).  The incidence of less frequently occurring...

FDA Encourages Applications for Orphan-Drug Status

Getting an orphan-drug designation opens the door to incentives once the FDA approves a medicine for sale in the U.S., including 7 years’ marketing exclusivity and tax breaks.  Last year, just 250 requests for orphan-drug designation were filed, and 160 were...