It’s official. The wires had been buzzing with rumors for several days, and today Pfizer (New York) announced that it would acquire Wyeth (Madison, NJ) for about $68 billion. The transaction will bolster Pfizer’s pipeline and improve its biopharmaceutical portfolio with the addition of Wyeth’s “Prevnar” pneumococcal vaccine and “Enbrel” arthritis treatment. The resulting company will be so diversified that it expects that no drug will account for more than 10% of its revenue in 2012, according to a Pfizer press release. Read more »

Innovation used to be a term dedicated to a company’s visions for growth. Keeping one eye on the roots of your business and the other on long-term prospects was a smart strategy. Against a backdrop of a nose-diving economy, however, it seems as if “innovation” now has less to do with growth and more to do with survival. Read more »

Erik Gordon, head of biomedical industry programs at Stevens Institute of Technology (Hoboken, NJ) compared Pfizer’s current crush of lawsuits to “having a thousand fleas attack a dog at the same time.” Last week, Pfizer finally decided it was time to lighten the load and the company agreed to settle a huge majority of its lawsuits over its now-withdrawn pain reliever “Bextra” and its still-marketed drug “Celebrex.” Read more »

I attended a session this morning at Interphex 2008 and the speaker pointed out that there are clear doubts among industry about harmonization. Will all three regions–the US, Europe, and Japan–really be able to pull off this massive effort? Industry doubts about harmonization have been around since, well, the idea of harmonization was introduced, but what is interesting to consider, is, does it matter? If FDA is fully behind harmonization and QbD, specifically ICH Q 8, Q9, and Q10, it may not matter whether or not Europe and Japan are also on board.

One case in point, I recently toured a manufacturing facility overseas that’s about half-way built. They have had a few inspections already and are gearing up for more before they become fully operational. I asked the manager which inspection he was most fearing–FDA’s, the UK’s, or any of the other national inspectors that may be stopping by to take a look around. He answered, “Well, FDA’s inspection is really the only one that matters.” And this was coming from a UK company at a UK plant.

If this is the feeling among plant managers worldwide, how important is harmonization? Now I’m not trying to downplay the importance of harmonization–in fact, I fully support it. In this global industry, global collaboration is a must. But playing devil’s advocate for a minute here, what if everyone just followed FDA’s rules and took its approvals or nonapprovals as final word?

As a law in my state, drivers are not “allowed” to pump their own gas. I suppose it has helped the Oregon economy with providing additional (read: low wage) jobs. In turn, our gas taxes may be a little higher than the rest of the country’s. Last week, however, as I pulled up to take another hit to the family budget with another fill-up, I noticed a sign at the station declaring “diesel customers: you are responsible for making sure the right gas is pumped into your vehicle.” Read more »