Author Archive

Xenotourism: Scary Stuff

Just came across an article on diabetics going to Mexico to receive pig xenotransplants. Unlike other forms of medical tourism, where patients travel to other countries for lower cost treatments, better quality treatments, or to receive ethically questionable organ transplants, xenotransplantation carries significant safety concerns. Xenotransplantation is the transplantation of organs or tissues from non-humans […]


The commercial prospects of biogenerics – how much will they save?

This follow-up to my post on the technical reasons why biogenerics are so hard to regulate provides some updates the status of biogenerics, background on the key issues, and the impacts on the industry of the various possible approval schemes. Clinical Trials The clinical trial requirement for biogenerics is the leading issue from a regulatory […]


VCs filling biotech funding gap

If there’s one sure rule about private equity, it is that there are no rules about private equity! Venture capitalists will tell you that they have different investment philosophies than everyone else, they’ll tell you that they’re not venture capitalists, they’ll tell you that they focus on areas that everyone else ignores. So, it should […]


Angels filling biotechnology funding gap

Biotechnology companies have been facing a widening funding gap. Between frozen federal research budgets and a growing focus among venture capitalists and senior partners for larger, more mature, biotechnology firms – at the expense of smaller ones – a funding gap is growing between basic research and initial proof-of-principle commercial research. So, who fills the […]


Looking beyond traditional markets

The United States is the world’s largest pharmaceutical market. Japan is the second largest, although the combined European Union is larger than the Japanese market (but smaller than the U.S.). Naturally, any company looking to sell drugs should focus on these markets, but there are reasons to reach out into smaller markets: This article describes […]


Price controls and compulsory licensing give buyers more power … for a price.

Countries use various methods to control drug expenditures. Beyond simple negotiation, countries can also implement price controls or use WTO-authorized compulsory licensing, which enables a country to produce generic versions of branded drugs if they face a health crisis without violating international patent agreements. The United States threatened to use compulsory licensing to acquire cheap […]


Carnival of Biotechnology

Investing and Clinical Trials PharmaGossip has an illuminating excerpt from The End of Medicine describing a method to invest in drug companies as they progress through clinical trials. Ted Love, CEO of Nuvelo Inc., explains how biotechnology companies are frequently able to recover from seemingly disastrous clinical trial failures. Patents When manufacturers seeking to sell […]


Why are biogenerics so hard to regulate?

There’s been a lot of press floating around lately about the push to develop a framework for biogeneric (or biosimilar, or follow-on, etc.) approvals. Why are biogenerics so hard to regulate? Why can’t they just follow the same path as traditional generic drugs? The answer lies in their size and complexity. I’ll use the following […]