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Gene therapies for hemophilia hit the mark in clinical trials

Although the first gene therapy proposals are almost 50 years old1, the past year has been a coming of age for this field. In March, after approval by the European Medicines Agency the previous year, the first patient was treated with a commercial gene therapy to correct an inherited immunodeficiency by modifying blood stem cells ex vivo. In August, a genetically modified cell product was approved for the first time by the US Food and Drug Administration (FDA), comprising engineered…

Fresh from the biotech pipeline—2017

The mid-December approval of a gene therapy packaged inside an adeno-associated virus (AAV) vector to treat patients with certain inherited retinal diseases capped several decades of effort to bring in vivo gene therapy to patients. It was also the cherry on top of an impressive year… Para acessar a publicação na íntegra clique aqui Fonte: NATURE BIOTECHNOLOGY VOLUME 36 NUMBER 2 FEBRUARY 2018 131…

FDA warns public of dangers of DIY gene therapy

People are experimenting on themselves with unlicensed gene therapies and publicizing the events widely, prompting the US Food and Drug Administration (FDA) to issue a statement on November 21 cautioning against do-it-yourself (DIY) gene therapies… Para acessar a publicação na íntegra clique aqui Fonte: NATURE BIOTECHNOLOGY VOLUME 36 NUMBER 2 FEBRUARY 2018…

Top product sales forecasts for 2018

The top-selling drugs of 2018 are set to be a mix of old-timers and newcomers, shows global consensus sales forecast data from EvaluatePharma. The top five products on this forecast list are repeat bestsellers, and AbbVie’s adalimumab held the top slot in both 2016 and 2017. Several of these top earners are likely to come under pressure in upcoming years from biosimilar launches… Para acessar a publicação na íntegra clique aqui Fonte: 86 | FEBRUARY 2018 | VOLUME 17 www.nature.com/nrd…

Top product sales forecasts for 2018

The top-selling drugs of 2018 are set to be a mix of old-timers and newcomers, shows global consensus sales forecast data from EvaluatePharma. The top five products on this forecast list are repeat bestsellers, and AbbVie’s adalimumab held the top slot in both 2016 and 2017. Several of these top earners are likely to come under pressure in upcoming years from biosimilar launches… Click here to original publication. Fonte: 86 | FEBRUARY 2018 | VOLUME 17 www.nature.com/nrd…

Biopharma deal-making in 2017

Drug makers in 2017 again faced many of the uncertainties and pressures experienced in 2016, including continued public and political criticism of drug pricing, and the urgency to put the patient and value-based health care at the forefront of medicine… Para acessar a publicação na íntegra clique aqui Fonte: NATURE REVIEWS | DRUG DISCOVERY VOLUME 17 | FEBRUARY 2018 | 91…

Innovation in the Amazon

But the wandering-spider, or Phoneutria nigriventer, will be soon known for other reason. Biozeus, a private biotechnology company in Rio de Janeiro, is developing a cream for erectile dysfunction based on a peptide found in the spider’s venom. The project is in its last stages with human trials set to begin in a couple of months… Para acessar a publicação na íntegra clique aqui Fonte: BBC.com…

First in vivo gene-editing drugs enter the clinic

The FDA posted strong approval numbers last year, rebounding from a steep drop in 2016. The agency’s Center for Drug Evaluation and Research (CDER) approved a total of 46 new drugs in 2017, the most since the peak of 59 in 1996 (FIG. 1; TABLE 1). This puts last year’s approval count well above the 5-year and 10-year averages (36 and 32, respectively)… Para acessar a publicação na íntegra clique aqui Fonte: NATURE REVIEWS | DRUG DISCOVERY ADVANCE ONLINE PUBLICATION | 1…

Drugmakers cling to dual IL-13/IL-4 blockbuster hop

The recent failure of AstraZeneca’s interleukin-13 (IL-13) inhibitor tralokinumab to show  efficacy in two phase 3 trials in asthma extends an already lengthy rap sheet against a therapeutic target that has confounded drug developers’ expectations. Despite widespread recognition of the central role IL-13 plays in mediating allergic disease, companies have struggled for more than a decade to produce clear-cut clinical evidence that targeting the cytokine will benefit patients… Para acessar a publicação na íntegra clique aqui Fonte: NATURE BIOTECHNOLOGY VOLUME 36 NUMBER 1 JANUARY 2018…