The manufacturing plant was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance. National Gaucher Foundation CEO and executive director Rhonda Buyers said,
Ben Venue Laboratories has initiated this voluntary recall on 14 February 2014 and has informed the US Food and Drug Administration (FDA) of its actions. The company is
The opinion will be subject to review by the EC, which finally grants the decision on orphan drug designation. ATTR-Amyloidosis or TTR amyloidosis is a severe and rare
EGPA, which can be life-threatening for some patients, is previously known as Churg-Strauss syndrome and it is a rare disease which is characterized by widespread inflammation in the
Q203 is being developed for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis and is the first drug in its class with an original mechanism of action. Under the
Compared to other molecules currently in development in the immune therapy cancer space, AUNP-12 provides a breakthrough mechanism of action in the PD-1 pathway. AUNP-12 is the only
Synribo, an oncology portfolio product, was originally granted an accelerated approval by the FDA in October 2012. Additional clinical trial data was required to fulfill post marketing requirements
Abilify Maintena will be the first commercialized product in Canada from the global Otsuka- Lundbeck alliance, which is focused on developing Central Nervous System (CNS) therapies worldwide. The
With the acquisition, Agenus will now be able to use 4-Antibody’ Retrocyte Display technology platform, which helps in the discovery and optimization of fully human antibodies against a
Under the deal, Clinipace will manage a major trial of PT20, a new iron-based phosphate binder, being developed for the treatment of hyperphosphataemia related to chronic kidney disease
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