FDA vs Merck....A must read

[Anonymous]

http://www.pharmalot.com/2012/02/misbranded-merck-flunks-januvia-follow-up-study/

So who is telling the truth?

 

[Anonymous]

http://www.pharmalot.com/2012/02/misbranded-merck-flunks-januvia-follow-up-study/

So who is telling the truth?

No disputing the facts.

No claims of not telling the truth. The FDA are saying that Merck didn't submit their stuff. Merck says they will vs the Feb 17th letter.

The other 20 months delay will attract a fine. Then the shit will hit the fan in the public sector.

Probably cost the az product some share.

 

[Anonymous]

Its about time the FDA has cracked down on this. Often these clinicals are done overseas. like India. This will give a more even playing field for us. Now we can have all of the information and share it with our docs.

 

[Anonymous]

While it isn't known yet whether Januvia has a serious issue with pancreatitis, because they don't seem to want to do the study, this could finally differentiate Onglyza from Januvia if Onglyza does have a much lower chance of causing this serious adverse event than Januvia. If it turns out to be a class dependent side effect then it will probably be bad news for all of the drugs in the class. AZ and BMS should consider jumping on right this one the protocola are decided. The FDA will make them do the studies anyway eventually if Januvia does have bad results. It is a risk to sales in the near term Onglyza if studies do come out poorly though.

 

[Anonymous]

Merck lies about safety data and patient safety. Viox and now Januvia.

Pattern?

Yes.

Yes it is.

A pattern.

Yes. It sure is.