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Sebelius on Vaccines

24 Nov 2009

Discussing whether a new $487M investment from the government will help speed up the production of the most important vaccines, with Kathy Sebelius, Health & Human Services secretary and CNBC's Mike Huckman.

The New Formula for Faster Vaccines

24 Nov 2009

Novartis is opening on Tuesday the country's first plant to produce flu vaccines using cell cultures. These vaccines are faster, better and cheaper to make than egg-based methods, reports CNBC's Mike Huckman.

Novartis Opens 1st US Plant for Flu Vaccine

24 Nov 2009

Cholesterol Drug Battle: Niaspan vs. Zetia 16 Nov 2009
Abbott Laboratories' Niaspan beat Merck's Zetia in a new study. CNBC's Mike Huckman has the details.

Cardiologist Grades Cholesterol Drug Study

16 Nov 2009

Abbott Laboratories' Niaspan beat Merck's Zetia in a new study. Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at The Cleveland Clinic, shares his reaction with CNBC's Mike Huckman.

Merck's Cholesterol Drugs Under Pressure

16 Nov 2009

A new study is putting Merck's cholesterol drugs under pressure today, reports CNBC's Mike Huckman, with Ken Frazier, Merck Global Human Health president.

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CNBC ON DIGG

Amgen's Party Pooper

Published: Monday, 19 Oct 2009 | 12:27 PM ET

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By: Mike Huckman
CNBC Correspondent

In case you weren't aware, tomorrow is "World Osteoporosis Day" or WOD, for short, as the International Osteoporosis Foundation hilariously refers to it, but biotech Amgen won't be celebrating the occasion.
Amgen

Had the FDA today approved AMGN's [AMGN Loading... () ] twice-a-year injectable bone drug, Prolia, the champagne corks would have been popping. But instead, the FDA handed Amgen the dreaded CRL.

What's that, you ask? CRL replaced the old approvable letters. The terminology was a bit confusing. People would see the word approvable and think, "Oh, good!" But it wasn't.

Approvable was a euphemism for delay as in, "We might approve the drug sometime down the road, if/when you dot an i or cross a t and/or provide us some more information/data."

This morning Amgen announced that the FDA wants more details on how the company will monitor patients once Prolia is on the market. And the agency requested Amgen do another study to see if Prolia works at preventing osteoporosis.

It was the second CRL to be disclosed this morning. Novartis [NVS Loading... () ] got one, too. NVS' is for a one-a-day inhaler to treat COPD, or what some more broadly refer to as smoker's cough.

Novartis would only say that the agency wants more info on the dosing. Sometimes companies fully disclose what's contained in a CRL, sometimes they reveal some or a little bit of information and other times nothing at all. I suspect that both companies got their respective CRLs last Friday or over the weekend since both press releases hit the wires bright and early.

Biopharma companies, it seems, have gotten so used to getting an approvable letter or CRL, that they all reach into the drawer and pull out the same press release template and just fill in the blanks. For example, Amgen says it "will work with the FDA to determine the appropriate next steps...." And Novartis says it "will continue to work closely with the FDA...." I guess Novartis must have a cozier relationship with regulators than Amgen. Kidding. Kidding!

P.S. Please tune in to CNBC's "Power Lunch" at noon ET for my exclusive interview with Pfizer [PFE Loading... () ] Chairman and CEO Jeff Kindler after the company reports earnings Tuesday morning.