Innovation Pharmaceuticals Inc (IPIX)

[garydaemon]

So was Menon involved in the Gov.GAIN act discussion?

This 2-day conference presents solutions through key notes, case study presentations, expert opinion, roundtable discussions and invites "KEY" influencers such as BARDA, NIH, FDA, grant agencies, pharma and academia, in the AMR discussion.

The World AntiMicrobial Resistance Congress gathers key stakeholders from government, funding agencies, pharma, academia and payers to discuss this urgent need for new antibiotics. President Obama has outlined his 5-year action plan to fight AMR and is seeking to double the AMR funding to $1.2B, but the bigger challenge is how to deliver these actions.

http://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2013/11/07/gain-how-a-new-law-is-stimulating-the-development-of-antibiotics

One of the GAIN Act's main provisions is Section 505E, which grants companies an additional five years of market exclusivity if they develop an antibiotic intended for a "qualified infectious disease." However, the act failed to describe which diseases are "qualified," leaving that distinction up to FDA regulators.
Those qualifying pathogens were as follows:Acinetobacter species Aspergillus species Burkholderia cepacia complex Campylobacter species Candida species Clostridium difficile EnterobacteriaceaeEnterococcus species Mycobacterium tuberculosis complexNeisseria gonorrhoeaeNeisseria meningitidisnon-tuberculous mycobacteria species Pseudomonas species.Staphylococcus aureus Streptococcus agalactiae Streptococcus pneumonia Streptococcus pyogenes Vibrio cholera Final Rule How ever, FDA has now released a final rule amending that list, adding several pathogens that were not in its draft form.
The three new qualifying pathogens are:Coccidioides species Cryptococcus species Helicobacter pylori
http://raps.org/regulatory-focus/news/2014/06/19395/FDA-Final-Rule-On-Qualifying-GAIN-Act-Pathogens/