BioSpace News Archive

A report from the Government Accountability Office said the FDA failed to live up to the legal requirements when approving drugs under a rare disease designation.

Shareholders raise concern over the fairness of the reverse merger and question potential conflicts of interest of OvaScience’s co-founder.

The American Society of Hematology Annual Meeting is always chock full of interesting research and development stories. Here’s a look at some of the highlights of the meeting so far, which is continuing today.

The idea of throwing Big Pharma under the bus in order to protect innovative biotech companies sparked a robust conversation at the seventh annual Forbes Healthcare Summit.

The placenta, sometimes called afterbirth, is described as an organ that develops in the uterus during pregnancy. Although research has been conducted on placentas for decades, three important studies were recently published related to the science of the placenta.

Novartis’ gene therapy treatment for spinal muscular atrophy could see approval as early as May of this year after the U.S. Food and Drug Administration granted AVXS-101, now dubbed Zolgensma, priority review.

The year 2018 saw a number of significant triumphs in the biopharma industry – increased numbers of drug approvals and near record-shattering IPOs, but the industry also saw its share of blemishes and black eyes from various corners of the globe.

argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that it will share the detailed data from its Phase 2 clinical trial of efgartigimod (ARGX-113) in immune thrombocytopenia (ITP)

The most commonly stated statistic about clinical trials is that for every one drug on the market, there are nine that failed. A look back through 2018 indicates there were a great many successes, but plenty of challenges as well. Here’s a look at 10 notable drug challenges of the year.