You would think if it shows up on July 4 as an orphan drug for an antibacterial for systemic uses that somewhere prior to July 4, a drug company would have applied for an orphan drug status and had that drug validated in order to proceed further. At this point, the only company that we are aware of is Insmed. Is it possible that Insmed is thinking there are more hoops to jump thru for NTM and CF, and maybe a quicker way to market Arikayce is as an antibacterial with a different delivery system. Amikacin is already a proven drug. What is the difference if amikacin is delivered as a liposomal or the current method? and is it safer?
Who knows what company has filed, as I was under the impression that Insmed was not going to reapply until the P3 study was completed.
4 July 2016 EMA/462942/2016
Information Management Division Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use July 2016
This document lists information on applications for centralised marketing authorisation for human medicines that the European Medicines Agency has received for evaluation. It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). For generic and biosimilar medicines, it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. This list only includes information for medicines whose applications have been validated at the time the report was compiled. The information in this report was compiled on 4 July 2016. Information on designated orphan medicines that are being assessed for marketing authorisation is also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP). Information in bold corresponds to new entries in the monthly list. Entries are removed from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website. Information on CHMP opinions is also published in the monthly CHMP highlights.
Orphan medicinal products
International non-proprietary name (salt, ester, derivative, etc.) / Common Name Therapeutic area3
Aceneuramic acid Other medicines for disorders of the musculoskeletal system
Amikacin Antibacterials for systemic use
I just noticed on the EMA website under the CHMP heading that new orphan drugs had submitted applications as of July 4. I tried to post the information but was unable to do so. Amikacin was one of them. Not sure what this means, but the information said that this could include medicines that had been withdrawn, which Insmed did in June..
Sure Terry. I sold quite a bit at the top, and bought more when its lower. Dont know where its going, but its IP is worth more than where it is now. You are the phony on this board!!
If that was the case, kvnmcdd, and many others would have your postings deleted all day long. You are FOS, and cannot back it up with facts!!
There is no PROOF. and they know it. They are just spewing BS. If there are no facts it is either speculation or BS, and we know Terry is full of BS, and Cj thinks like Terry.