“Are they surprised? I assume it will be water of a duck’s back; Pharma rarely show remorse.”
18 Jun 2013
Objectives & Methods: To investigate the clinical efficacy of BG-12 240 mg twice daily (BID) and three times daily (TID) in MSer subgroups stratified according to baseline demographic and disease characteristics including …
03 Jun 2013
PMLive. Biogen Idec says Tecfidera launch delayed in Europe. 31 May 2013 MSers in Europe who are eager to start Biogen Idec’s new oral treatment Dimethyl Fumarate (Tecfidera) will now have to wait until the second half …
22 May 2013
Biogen Idec announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of peginterferon beta-1a, a pegylated subcutaneous injectable candidate for …
19 Apr 2013
Biogen Idec recognizes that traditional pharmacy compounding can play a useful role in personalizing treatment for an individual patient. However, this should be done by licensed pharmacists who are trained and equipped …
Prof G I have been holding out for BG12. As I am not sure when BG12 will become available would you recommend I go onto fingolimod instead? I am currently on Copaxone. Thanks.
Unfortunately, I am not in a position to give you personal advice on this blog. I suggest you discuss things with your MSologist.
Me too; I have been waiting anxiously for BG-12 to be launched. When will it be available?
Something must be blowing in the wind! Prof. G appears to doing a Charles Saatchi. Although richer Biogen is not nearly as beautiful as Nigella Lawson.
This blog is not a forum for such puerile comments. This is a serious issue. Biogen-Idec are deliberately delaying the launch of an effective drug for MS when they have shown it be effective. The problem is that BG12 has been so overhyped that there are probably 1000's of people with MS in Europe who have been holding out for the drug. This leaves them in a very difficult situation. Should they continue to wait or should they make other plans?
I have asked someone at Biogen-Idec to provide an estimate of the launch date. I recall them saying at the ENS that it will be in November or December this year. This is hearsay I will get back to you ASAP.
I think I have very good relationship with Biogen. I am just taking them to task over poor communication. I am sure their reasons for delaying the launch are reasonable. All I asking for is more information and time to deal with MSer queries. The level of expectation in relation to BG12 is very high and MSers are disappointed about the delay. To be honest I still can't tell you why a data exclusivity query has delayed the launch. I can only assume it is more serious and the company needs to make sure their patent is protected. A similar thing is happening with Teriflunomide and Genzyme-Sanofi. At least with Genzyme-Sanofi we know what is happening.
Biogen-Idec are not the only Pharma Company that values their data:See Nature Medicine: http://www.nature.com/nm/journal/v19/n6/full/nm0613-658.htmlAccess denied The European Medicines Agency's quest to make data related to drug rejections and approvals publicly available ran into a major roadblock on 30 April when the EU's General Court issued a temporary injunction to block this transparency measure. The order came after two US companies—AbbVie, headquartered in North Chicago, Illinois, and InterMune in Brisbane, California—complained that the data release would compromise trade secrets. “This is an interim injunction, not a final judgment, but we are considering all options, including whether to appeal the court's interim decision,” says the European Medicines Agency's Martin Harvey-Allchurch, a spokesperson for the London-based regulator.
Just got some info back from the Biogen-Idec UK office; they are also in the dark on the launch date. They are however confident that it will be launched in Europe this unlike the situation with regard to Teriflunomide. I have asked someone in the Biogen-Idec International office as well and will get back to you as soon as I have heard.