FDA - READ THIS : QUALITY ISSUES ARE BAD IN NOVARTIS

[Anonymous]

Hmmmm - Tekturna / Amlodipine - approved! FTY-720 - approved! Clearly in the FDA penalty box! The axe is falling - whoops, duck, its another - approval! Seriously, no one who writes like a high school punk and talks so much angry smack is likely to be particularly smart or in the know. Some angry mid-level functionary, just an angry cork bobbing along in the current with no control over their world, trying to get even on Cafe Pharma. Or perhaps its some hedge fund genius who is racing to cover their short position. Sorry, champ.

 

[Anonymous]

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[Anonymous]

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[Anonymous]

Hmmmm - Tekturna / Amlodipine - approved! FTY-720 - approved! Clearly in the FDA penalty box! The axe is falling - whoops, duck, its another - approval! Seriously, no one who writes like a high school punk and talks so much angry smack is likely to be particularly smart or in the know. Some angry mid-level functionary, just an angry cork bobbing along in the current with no control over their world, trying to get even on Cafe Pharma. Or perhaps its some hedge fund genius who is racing to cover their short position. Sorry, champ.

Hmmmm - Tekturna / Amlodipine - approved! FTY-720 - approved! Clearly in the FDA penalty box! The axe is falling - whoops, duck, its another - approval! Seriously, no one who writes like a high school punk and talks so much angry smack is likely to be particularly smart or in the know. Some angry mid-level functionary, just an angry cork bobbing along in the current with no control over their world, trying to get even on Cafe Pharma. Or perhaps its some hedge fund genius who is racing to cover their short position. Sorry, champ.

Are you freaking kidding me?

A Tek/Amlo approval and FTY 720 a big deal? Gimme a break. Almo has been out for over a decade and Tek has had 0 issues for being on the market for 3 and a half years w/ 6 plus years of good data. What is Tek Amlo bringing to the mkt that hasn't been there for years?

Re: Gilenya you have a pt. This is a big development for treating ms, but it's a small mkt. Estimates show about 400,000 ppl in the US have MS. If we had 100,000 rx in a year it would be a miracle. Our cv products move 1.5 mil rx per month. It's like throwing a pe nle into the ocean and expecting a tsunami.

The FDA hates us for all the shit we've pulled. If we are fortunate to get the copd meds, the gouty arthritis treatment and the plavix competitor approved before the golden goose gets slaughtered, we may have a prayer, but that's a BIG IF!

 

[Anonymous]

. . . . Not to mention Reclast AE's that are being swept under the rug . . . side effects much more common/severe that originally thought

 

[Anonymous]

. . . . Not to mention Reclast AE's that are being swept under the rug . . . side effects much more common/severe that originally thought

You're right. I can't believe we've been getting by with this. AE's have been horrific. Would love to know the incidence of post dose symptoms since launch. Reclast is high on the FDA's watch list.

 

[Anonymous]

You're right. I can't believe we've been getting by with this. AE's have been horrific. Would love to know the incidence of post dose symptoms since launch. Reclast is high on the FDA's watch list.

What about Tasigna's AEs as well? Grade 3/4 AEs less than 1% my ass. More hospitalizations than ever......

 

[Anonymous]

So the FDA wanted the answers last month.... what happened? Do they believe NVS bogus.. that all is fixed?? Although things only got worse with more savings??

 

[Anonymous]

Hmmmmmm

 

[Anonymous]

We know who you are. We will find you. You will join the unemployed.

 

[Anonymous]

I don't think so Mr. Good Ole Boys Club.

 

[Anonymous]

Would you care to elaborate?

That is very sad for patients with adv carcinoid who may have benifited from Afinitor.
Was there an issue with how the carciniod study was conducted? Afintior was approved for advanced pancreatic neuroendocrine tumors.

 

[Anonymous]

Aw, c'mon now, unemployment as a threat? Bring out the really impressive stuff, like this from the article "6 Creepy New Weapons":

"Penn State’s College of Medicine researchers agreed, contrary to accepted principles of medical ethics, that “the development and use of non-lethal calmative techniques is both achievable and desirable,” and identified a large number of promising drug candidates, including benzodiazepines like Valium, serotonin-reuptake inhibitors like Prozac, and opiate derivatives like morphine, fentanyl, and carfentanyl, the last commonly used by veterinarians to sedate large animals. The only problems they saw were in developing effective delivery vehicles and regulating dosages, but these problems could be solved readily, they recommended, through strategic partnerships with the pharmaceutical industry."