Genzyme Corporation’s (GENZ) Lumizyme failed to receive approval from the US Food and Drug Administration (FDA) for the treatment of Pompe disease. The FDA issued a complete response letter (CRL) stating that the agency will not grant approval unless the company addresses the manufacturing issues at its Allston Landing plant in Boston. Genzyme said that it believes that other elements like the Risk Evaluation and Mitigation Strategy (REMS), product label and post-marketing requirements, have been satisfactorily addressed. The FDA’s response on Lumizyme does not come as a surprise. The news regarding the delay in Lumizyme’s approval follows a recent announcement regarding the detection of contamination in vials of five drugs marketed by the company. The agency completed its inspection of the company’s plant last week and has provided Genzyme with a list related to the manufacturing deficiencies found at the plant. The company stated that ...

Waterford, Ireland

Our faith is weakening. That is, our faith that the government will be able to cause inflation, sooner or later. Let’s review our own narrative: deflation now, inflation later.

It’s very simple. Maybe too simple. After a half a century of credit expansion, we now have a credit contraction. In this sense, everything is happening as it should.

There was a crash and credit crunch at the end of last year. Then, the feds panicked. They fought back with monetary and fiscal stimulus. Rates were cut to nearly zero. The Fed flooded the system with cash and easy credit – buying up Wall Street’s bad investments…propping up bad banks…and guaranteeing trillions worth of bad debt. And the federal government passed a stimulus program that authorized more than $700 billion in spending.

Beginning on March 9th, we also got a big bounce in the world’s stock markets – just as we

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