After I had fnished reading the recent Supreme Court decision in Riegel v. Medtronic and some news reports describing the supposed implications of the decision for pharma, I was confused. Were the implications for pharma product liability cases broad and profound or narrow and limited? Certainly, the upcoming Wyeth Supreme Court case will have its [...]
Avastin Distribution Change - Open Letter
I read today’s WSJ Health Blog on Avastin thinking that Genentech had appeased eye specialists by maintaining distribution of Avastin to compounding pharmacies, but after reading the above open letter, I’m confused about Genentech’s actions in the recent past and about what it’s planning to do in the near future. [...]
Last week Byron Dorgan, Senator for North Dakota and colleagues, including Olympia Snowe, Republican from Maine submitted legislation to the U.S. Senate that would amend the Food, Drug and Cosmetic Act to provide for drug importation by non-manufacturing companies and individuals into the United States from registered exporters in other countries. For individuals, importation would be limited [...]
This press release from FDA cracking down on compounding practices got some broad coverage this past week. Compounding, the selective creation of new drugs using bulk drug substance or drug products by pharmacists, is a legal activity when done for an individual patient with special drug needs, in response to a valid prescription. FDA maintains a web [...]
Pharma’s Cutting Edge Vol. 4 Number 3 - March 2006
Review of EMEA Biosimilars Guidelines
Last month EMEA (the European Medicines Agency) released final guidelines containing details of clinical, nonclinical and quality expectations for biosimilar protein therapeutics (aka generic biologics, aka biogenerics, aka follow-on biologics or proteins). These guidelines were themselves as expansion of the general guideline [...]
