Archive for May, 2009

How Things Change

Saturday, May 9th, 2009

Celebrity gossip Perez Hilton (né Mario Lavandeira)  has won an injunction against those who operate the site PerezRevenge.  The PerezRevenge site styled itself as an antidote to Lavandiera’s mean-spiritedness.

Here’s the rub:  When Lavandeira started his blogging career he called his site PageSixSixSix (a rather obvious play on the New York Post’s Page Six gossip column).  The Post objected, and won.

Then he adopted the moniker Perez Hilton, an obvious reference to Hilton heiress, Paris Hilton.  Indeed, a good choice since both are famous for nothing.

“He also routinely doctors celebrity photos, arguing that sprinkling cocaine dots on them is a transformative use, entitling him to publish them.”  Ugh.

It is ironic that one becomes famous “borrowing” from others, but when others borrow from you when seeking fame, you object like it’s nobody’s business…  With any luck, Perez (and Paris) will just be a flash in the pan.

How ‘bout that picture?

Sanofi Facility Approved in U.S.

Thursday, May 7th, 2009

Earlier today it was announced that the FDA has approved a new production facility for the manufacture of flu vaccines.   The facility, based in the U.S. is owned by sanofi pasteur, (a division of our client sanofi-aventis) which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur’s production capability.

Congratulations to them.  (Send some Fluzone our way!)

FDA Playing Catch-Up Again

Thursday, May 7th, 2009

FDAlogo The FDA is playing catch up, again.  On the heels of requiring the dreaded black box warning for Botox and similar products, the FDA today announced it would also require black box warnings for two testosterone replacement productsAndroGel 1% and Testim 1%.

After having been on the market for some time, the FDA has decided that the products could have negative effects if children are exposed to the products.

Mary Roberts, an FDA medical officer, said in some instances people were applying the product to their chest and then holding their children without wearing shirts.

You may view the FDA’s press release here.

FDA Nominee Faces Senate

Thursday, May 7th, 2009

fdalogoMargaret Hamburg, President Obama’s selection to head the U.S. Food & Drug Administration (“FDA”) is scheduled to face senators today as they consider her nomination.

Hamburg is a physician and a bioterrorism expert who has served as Commissioner for Health of New York City. 

The Senate is expected to grill Hamburg in light of some notable FDA failures such as salmonella outbreak in peanut products early this year, tomatoes and peppers in 2008 and spinach in 2006.