Although approvals were down year-on-year, December saw a rash of drug registrations, which included innovative products like MACI (autologous chondrocytes on an implantable artificial matrix), the antisense molecule Spinraza (nusinersen), and Zinplava, a fully human monoclonal antibody that targets Clostridium difficile toxin B. However, complete response letters predominated more than in previous quarters, with setbacks for Cempra’s solithera and Regeneron’s sarilumab. Decisions on several biosimilars are on the horizon. NATURE BIOTECHNOLOGY VOLUME 35 NUMBER 2 FEBRUARY 2017 Para acessar a…
Novartis trial validates inflammasome as chronic disease driver
The dramatic finding that an antibody that inhibits interleukin-1b (IL-1b) can reduce the risk of heart attack and stroke is the first clinical evidence that tackling the inflammatory component of cardiovascular disease can benefit patients. Para acessar a publicação na íntegra clique aqui Fonte: NATURE BIOTECHNOLOGY VOLUME 35 NUMBER 10 OCTOBER 2017 893 …
Speed and oversight: FDA Commissioner Gottlieb acts on pledges
In late August, in a rare tide of bipartisan support, the US Congress passed legislation to reauthorize user fee programs for the next five years… Para acessar a publicação na íntegra clique aqui Fonte: NATURE BIOTECHNOLOGY VOLUME 35 NUMBER 10 OCTOBER 2017…
Epic $12 billion deal and FDA’s approval raise CAR-T to new heights
The strategy of engineering patients’ own T cells for cancer therapy got two major endorsements in late August, one financial and one regulatory… Para acessar a publicação na íntegra clique aqui…
First metabolic oncology inhibitor gets FDA green light, with record price tag
On August 1, the US Food and Drug Administration (FDA) granted full approval to an isocitrate dehydrogenase 2 (IDH2) enzyme inhibitor to treat relapsed or refractory acute myelogenous leukemia (AML)… Para acessar a publicação na íntegra clique aqui Fonte: NATURE BIOTECHNOLOGY VOLUME 35 NUMBER 10 OCTOBER 2017…
NIH Centers for Accelerated Innovations Program: principles, practices, successes and challenges
There is a chasm in the path from basic biomedical research discoveries to their clinical application owing to inadequate funding for support of proof-of-conceptor validation studies for early-stage development of new technologies… Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 16 | OCTOBER 2017 | 1 Para acessar a publicação na íntegra clique aqui…