This December, Achaogen released much data on 2 plazomicin trials: the pivotal EPIC study comparing plazomicin / levofloxacin with meropenem / levofloxacin in cUTI is the one we want to look at today because it is interpretable, while the other trial Continue reading All Smiles at the Press Conference: Plazo+Levo Delivers
In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to Continue reading The 10 x ’20 Goal – Are We On Track?
FOR PART 1, CLICK HERE Should we assume that the results of this Global Epi Study were the reason why Sanofi became disillusioned about the prospects of KB001? Or was it an internal strategic decision based on portfolio-review where KB001 just Continue reading The Demise of KB001 (Part 2): An Anti-Pseudomonas Antibody Hits the Dust (instead of Paydirt)
Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir. When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK’744 LAP. When injected intramuscularly, ‘744 LAP it has a half-life of >1 month which makes it ideally Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?
There are numerous reasons why drugs get stuck in development. Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well. For instance regulatory issues or manufacturing, difficulties can stop a program. Continue reading Why Some Did Not Make It