Healthcare | Lifesciences | Business & Technology Consulting

 

 

 

Navigate Our Site with 1-2-3

 

 

More Molecules More Problems--Is the FDA Leaving $4 Trillion on the Table?

Last year I authored this statement, “The FDA has undergone transformations in the past several years in hopes of making it a more efficient regulatory body.” A year later and with the agency’s annual 2014 results published, we see yet more positive trends. Last year the FDA’s Center for Drug Evaluation and Research (CDER) approved 41 new molecular entities and biologics—well above their decade average of 25 approvals. (1) This doesn’t mean the FDA can stop moving forward. In one of...

19 - February - 2015

Drug Discovery Cost Rise 145% — You are Catching a Break

The premier study on drug development costs was released and the results will astonish—costs have increased by 145% in the past decade (1). In 2003 the Tufts Center for the Study of Drug Development released what has become the financial benchmark for comparing drug development costs. In 2003 the average cost was estimated to be $800 million. The new cost--$2.6 billion. But I'll explain below, why consumers are actually getting a great deal on what they pay at the pharmacy for...

24 - January - 2015

Health Sector Logs Big Gains in 2014 -- Four Predictions for 2015

2014 has concluded and it was very kind to the portfolios of Health and Life Science executives. As of today, the Dow Jones U.S. Healthcare broad industry index returned 25% (second only to Utilities +26%) during 2014. Healthcare was tops during the past three years, with annualized returns of +27%. The Dow Jones U.S. Healthcare index includes: Providers, Equipment, Supplies, Biotech and Pharma (1). The companies featured in my blog have done even better, returning on average +82% this year....

05 - January - 2015

Ebola: The Scariest Stories Are Always Non-Fiction

It was the year 2014...   The World Health Organization (WHO) issues this frightening  statement, "In a post-antibiotic era in which common infections and minor injuries can kill - far from being an apocalyptic fantasy, is instead a very real possibility for the 21st Century."   Drug development slows. The approval of antibiotics and antivirals have been been cut by two-thirds during the period from 1980 to 2009.  Infectious disease experts maintain overuse has...

31 - October - 2014

On Leadership - Are You Raising a Wolf or Dog Pack?

A new study presented at the Animal Behavior Society Conference categorizes wolves *not* dogs as the more tolerant, cooperative and independent thinking of the species.   The theory and supporting data presented goes on to explain that we have bred and trained dogs into a hierarchal, obedient species.    Our four-legged friends have become ever more reliant on us, their human pack leaders.     Two separate tests were conducted, both studies were evenly...

04 - October - 2014

Patent Headwinds- Trouble Ahead for Biotech Innovation

Newly issued guidance by the Supreme Court has the potential to re-shape the landscape of biologic drug and product commercialization. Two recent Supreme Court decisions have emboldened the U.S. Patent and Trademark Office (USPTO) to announce that thousands of patents, if reviewed today, would never have been approved.The most recent, 2013 Association for Molecular Pathology. Myriad Genetics Inc., argued that human genes can not be patented because they occur naturally.  2012 Mayo...

31 - July - 2014
First Previous 1-6 7-12 13-18 19-24 25-25 Next Last

Join CompassX College of Knowledge

Email:

Facebook

Latest News