No dia 16 de novembro de 2022, o Dr. John Stuart, professor do King`s College de Londres visitou o CIEnP e proferiu uma palestra sobre “ Mechanisms of TRPA1-mediated analgesia”. O Professor Stuart trabalhou por mais de duas décadas como chefe da equipe de pesquisa pré-clínica na área de dor da empresa farmacêutica Novartis em Londres. O professor Stuart é reconhecido mundialmente como um grande pesquisador na área de dor , especialmente no desenvolvimento de pesquisa pré-clínica destinada ao desenvolvimento…
FDA advisory committee votes for approval of first microbiome-based drug, despite data problems
Rebiotix’s microbiota-based RBX2660 could secure FDA approval to reduce C. difficile infection (CDI) recurrence, following a positive vote from the agency’s advisory committee. The FDA is due to rule on the live biotherapeutic — made from human stool — by mid-November, positioning it to potentially become the first microbiome-based drug to get the regulatory nod in the USA… Para acessar a publicação na íntegra clique aqui Fonte: 786 | november 2022 | volume 21 news in brief www.nature.com/nrd…
FDA new drug approvals in Q3 2022
The FDA approved 12 novel medicines in the third quarter of the year (Table 1), an uptick in activity after a slow first half. This apparent acceleration is a recent phenomenon, however, with no first-time green lights awarded in July, and only two in August. The balance came in September, and many will be hoping that this pace is maintained for the rest of the year Para acessar a publicação na íntegra clique aqui Fonte 788 | November 2022 | volume 21 biobusiNess briefs www.nature.com/nrd…
Amylyx’s ALS therapy secures FDA approval, as regulatory flexibility trumps underwhelming data
The FDA granted full approval to Amylyx’s AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS), a severe neurological disorder that causes paralysis and death. The agency convened its independent experts twice to discuss the therapy’s mixed and complex data package. AMX0035 is the third drug to secure FDA approval for ALS, following now-generic riluzole in 1995 and Mitsubishi Tanabe’s edaravone in 2017… Para acessar a publicação na íntegra clique aqui Fonte 786 | november 2022 | volume 21 news in brief www.nature.com/nrd…