Pharma’s Cutting Edge

Yesterday, I presented my overview of the US Supreme Court decision in Wyeth v Levine, to join the thousands of other overviews published online in the last couple of days.  Many of those commenting are focusing on the implications of the decision for consumers and lawyers.  You will find less commentary on the likely business [...]

March 6th, 2009 | Category: Drug Safety, FDA, Healthcare Delivery, Legislation, Product Quality, Public Perceptions | Leave a comment

When I reported on the implications of Riegel v Medtronic for device manufacturers in February of last year, I indicated that the related Wyeth v Levine case would have potentially farther reaching implications for the pharmaceutical industry.  Yesterday, the US Supreme Court issued its 6-3 opinion in the case.  Let’s have a look at the [...]

March 5th, 2009 | Category: Drug Safety, FDA, Healthcare Delivery, Legislation, Product Quality, Public Perceptions | Comments (1)

For the last few years, I have held an opinion contrary to most of my colleagues in the industry–that sponsors should be required to conduct large (simple) safety studies prior to marketing authorization for drugs intended to be used chronically in large, especially elderly, populations.  Such studies would have as their primary goal a safety evaluation including [...]

November 20th, 2008 | Category: Drug Safety, FDA, Public Perceptions, Sales and Marketing | Leave a comment

 
ASBMR was eventful this year, with PMP osteoporosis trial news from several companies, most notably fracture data from Amgen’s denosumab and comparative BMD data from Merck’s odanacatib.
Of course, it’s easy enough for you to learn about these presentations from other news sources, so I won’t spend much time on them.  Here’s the gist:  Denosumab, the [...]

September 18th, 2008 | Tags: bisphosphanate, cathepsin K, osteoporosis, RANKL, SERM | Category: Clinical Research, FDA, Public Perceptions, Technology | Comments (1)