rebif fda approval

First is some good news for Avonex and Rebif users. It looks like Biogen-Idec is going to be seeking marketing approval for monthly dosing later this year. http://www.medpagetoday.com/Neurology/MultipleSclerosis/36993?utm_source=share&utm_medium=mobile&utm_campaign=medpage%2Biphone%20app Second is kind of a double edged sword. The FDA has approved over the counter sale of Oxytrol, a drug aimed at overactive bladder. They have approved it for sale to women bu not men.

Neurologist do not like to put you in [the PPMS category] because there are no FDA approved treatments for PPMS. Insurance companies do not have to pay for DMDs since they are not FDA approved." ~ "PPMS - how were you diagnosed?" http://www.medhelp.org/posts/Multiple-Sclerosis/PPMS---how-were-you-diagnosed/show/1235216 This is a good point, which I did not realize.

The FDA must approve or disapprove of telaprevir on or before May 23 of this year. How long it will take to get on the drug formularies is something we do not know yet.

As some may have seen, Abagio the 2nd oral is now approved. Important to note (my opinion) - When compared to Rebif. Don't mean to be skeptical my friends, I'm just the type of person who wants some comparisons to existing meds with track records.

Earlier Phase 2 studies showed that treatment with alemtuzumab reduced the accumulation of disability and the frequency of relapses in people with early relapsing-remitting MS, compared to Rebif® (interferon-beta-1a-rebif/index.aspx, interferon beta-1a, EMD Serono, Inc. and Pfizer, Inc.). (New England Journal of Medicine 2008 359;17:30-45) Rebif is a registered trademark of EMD Serono, Inc. and Pfizer, Inc. http://www.nationalmssociety.org/news/news-detail/index.aspx?

I was offered to apply for the study, but I am going to wait for the approval from the FDA.

m not sure how much stock can be placed in a desk reference that is 24 years old and published 6 years prior to a drug getting FDA approval. Basically no one had used it at that point bar very small numbers of participants on trials. I'm on a drug trial now myself and know full well that every little thing I mention gets documented in triplicate on the understanding that even a vague correlation will need to be reported when they approach the FDA for licensing.

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit. The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for thatendpoint.

You can thank our FDA for this delay. Here is an example of how their drug approval process kills thousands of people each year! http://www.lef.org/magazine/mag2010/nov2010_FDA-Delay-of-One-Drug-Causes-Lost-Life-Years_01.

shutdown did not affect the timeline for approval. The PDUFA decision date for sofosbuvir is December 8 or 9 depending on where you look. The overall tone of this document is very encouraging for a swift approval. As a genotype 2 hoping for the all oral treatment ASAP this is very good news. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371877.pdf?

ve been following BG12 and the majority of the mentions of its efficacy and forward path in the FDA approval process does seem to come from the financial advisers who rate stocks as to whether investors should buy, hold or sell. Right now they are all saying either buy or hold with Biogen Idec, because of the promise that BG12 will make lots of money. There may be some new news on BG12 in the ECTRIMS video links I just posted. That would give the medical perspective.

Each drug trial and treatment requires an approval from the FDA, to the best of my knowledge. In that regard, the FDA so far as Vertex may approval a plan for treating naives, a separate plan for treating past TX failures, and I assume there is one for co-infected (HCV &HIV) as well. Right now there is a current trial for BID dosing, but approval will be based on 3X daily and at some point twice daily may see an additional application.

Vertex has begun the application process for approval with the fda. The process should be completed by the end of this year with approval coming shortly after that. The results are promising and I believe the fda is going to put it on the fast track for approval. My doctor told me 6 months ago it will be probably be ready by the end of 2010. Like pcds says though, there is no way to know for sure. It may be sometime in 2011 before it is available. Hang in there!

While you can get your insurance companies to approve the treatment it still has not been approved by the FDA for ovca and my guess is since the fda has pulled their approval for breast cancer, it may be unlikely approved for ovca. I just finished cycle 4 of Avastin and am considering a change to another treatment option. I have had dibilitating headaches from Avastin. As well, I feel like my body and mind are racing....very anxious.

Because of my persistence, I received three phone calls from the FDA today. I'm going to now present you with the clarity of what's about to happen with the "Rolling NDA" (New Drug Application) from Vertex and other pharmaceutical companies. A Rolling NDA is an application to have the FDA put this drug on a “Priority Approval” as opposed to a “Standard Approval”. Here's the difference.

Update. The medication was FDA approved recently and will be available next year. http://www.medscape.com/viewarticle/731619 " FDA Approves Once-Daily Lurasidone for Schizophrenia Yael Waknine October 29, 2010 — The US Food and Drug Administration (FDA) has approved the atypical antipsychotic lurasidone (Latuda tablets; Sunovion Pharmaceuticals Inc) for the once-daily treatment of patients with schizophrenia...

Some people choose not to use them, which is fine, however, they are available by prescription and have been vetted through the FDA approval process. In dealing with this have you ever talked about this with a therapist? I am a big proponent of talk therapy...while meds are great tool to use, I believe they are by no means a magic pill; but combined with education about why you think the way you do, it can be a very powerful tool in thriving with this....keep us posted!

For example, when a patient is proven to be so severely ill that he cannot wait for drug approval, how does the FDA and the manufacturer know for sure if the toxcity of the drug is due to the drug or the severe illness of the patient? It is possible that the drug would be perfectly safe for a Stage 2 patient but not a patient with late Stage 4. In the drug companies eyes, this is not in their best interest when they want to get a drug approved.

Rebif fda approval

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