Our gut microbiomes are complex, consisting of hundreds of bacte-rial species. These bacteria influence not only the activity of our gut, but also our neural development and response to drug treatments. It has proven difficult to determine the links between the microbiome and human health, and until recently, no microbiome-based therapies were approved by the US Food and Drug Administration (FDA) or the European Medicines Agency. Para acessar a publicação na íntegra clique aqui Fonte: nature biotechnology Volume 41 | January 2023 | 1 | 1…
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… Click here to original publication. 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 Click here to original publication. 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… Click here to original publication. Fonte 786 | november 2022 | volume 21 news in brief www.nature.com/nrd…
Nintx and CIEnP partner to develop multi-target therapies against inflammatory bowel diseases
Plants and microorganisms synthesize secondary metabolites (natural products) to survive. As humans share genes with all living organisms, it is well established that natural products can modulate biological targets in our genome. However, recent scientific evidence, such as the one produced by the American Gut Project, clearly demonstrates that natural products, specially derived from plants, may also deeply modulate the human microbiome. Hence, plant-based natural products bear huge potential to serve as a superb platform to modulate human biological targets and the microbiome concomitantly, affording therapies…
Fresh from the biotech pipeline: too much, too fast?
Looking at 2021’s US Food and Drug Administration (FDA) drug approvals, one might not have known there was still a major health crisis underway. More than 50 new drugs were waved through — close to 2018’s all-time high and on a par with those in 2020 (Fig. 1 and Table 1), the first pandemic year. On top of its usual workload, the FDA faced political pressure to accelerate already speedy approval timelines for COVID-19 vaccines and therapeutics… Fonte: Nature Biotechnology | VOL 40 | February 2022 | 155–162 | www.nature.com/naturebiotechnology 155 Click…
2021 FDA approvals
The FDA’s approval count last year was in line with recent trends, despite the continued impact of COVID-19. The agency’s Center for Drug Evaluation and Research (CDER) approved 50 novel therapeutics in 2021, down from 53 in 2020 (Fig. 1; Table 1). The 5-year average sits at 51 drugs per year. A decade ago, it was 24 drugs per year…. Click here to original publication. Fonte: Nature Reviews | DRUG DISCOVERY volume 21 | February 2022 | 83…
Drug pipeline 3Q21—mixed news for genetic therapies
Zydus Cadila Healthcare’s COVID-19 vaccine—the world’s first DNA vaccine approved for humans—got the nod in the form of an Emergency Use Authorization from India’s Central Drugs Standard Control Organisation. Regeneron’s monoclonal antibody (mAb) cocktail Ronapreve continued to shine in clinical trials, with the latest study reporting it protects people exposed to SARS-CoV-2. Meanwhile, the European Medicines Agency (EMA) got out ahead of the US Food and Drug Administration (FDA)… Click here to original publication. Fonte: 1326newsNature Biotechnology | VOL 39 | November 2021 |…
FDA new drug approvals in Q3 2021
The biggest FDA approval of the third quarter was for a product that has already been used in more than 130 countries. August saw the full approval of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for those aged 16 and over, 8 months after it was initially granted emergency use authorization… Click here to original publication. Fonte: volume 20 | November 2021 | 807 biobusiNess briefs Nature…
FDA approves AstraZeneca’s anifrolumab for lupus
The FDA has approved AstraZeneca’s anifrolumab for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. This is the first new approval for these patients in 10 years, and just the second in the past 60 years. Click here to original publication. Fonte: 658 | SEPTEMBER 2021 | volume 20 NEwS in BRiEf www.nature.com/nrd…