What FDA decisions have you missed recently?  Continue Reading..

When it comes to determining the underlying cause of a breach in good manufacturing practices, industry often falls back on human error and looks no farther into the matter. However, as Life Science Training Institute’s expert Joanna Gallant describes, retraining employees is only going to go so far and, more often than not, will not even be the appropriate CAPA for the issue. In part one of this four-part series, Gallant discusses where...  Continue Reading..

Within the last 10 years, a number of nonprofit groups, including the Michael J. Fox Foundation and the Multiple Myeloma Research Foundation, have taken a similar approach to ensuring that their targeted patient populations are being well represented in pharma R&D.  Continue Reading..

What FDA decisions have you missed recently?  Continue Reading..

As the call for transparency grows louder in the pharma industry, the question arises: are drugmakers equipped with all they need to be transparent — especially when it comes to demonstrating their drugs’ economic value?  Continue Reading..

What regulatory decisions have you missed recently?  Continue Reading..

If Express Scripts should have its way, what would happen to inter-industry competition between the pharma players — specifically in the cancer space? If price tags are altered based off a drug’s performance, it seems to me the industry and its ways of quantifying success and leadership in the market will be faced with change as well — but it’s not entirely clear it will be what Express Scripts had in mind.  Continue Reading..

What FDA decisions have you missed recently?  Continue Reading..

A few months ago, Senator Elizabeth Warren launched a proposal for a “swear jar” bill that would require law-breaking Big Pharma companies to contribute 1 percent of the profits from each of their blockbuster drugs to NIH research. While this proposal was highly contested by members of the industry, I questioned if there couldn’t be a benefit to this bill apart from punishing law breakers and bolstering drug R&D. Would...  Continue Reading..

What FDA decisions have you missed recently?  Continue Reading..