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The company is seeking approval depending on the Reprieve clinical study results, which determined the long-term maintenance of efficacy and safety of Fanapt antipsychotic agent. The agency is

The MAA for GRASPA, ERYTECH’s lead product, consisting of asparaginase encapsulated in red blood cells, is based on the positive findings of the pivotal GRASPALL 2009-06 Phase 2/3

There is no set expiration date for the program. The Company intends to use cash on hand, cash generated from operations, existing credit facilities or other financing to

Chiltern now comprises 3,700 people across 47 countries, expanding Chiltern’s footprint in Europe, North America and Asia-Pacific. The acquisition enhances Chiltern’s oncology, biopharma and source offerings, broadens its

The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality

The companies started the collaboration in 2014 and made better progress in the discovery of new compounds with activity against gram-positive and gram-negative bacteria. Under the partnership, which

Several reports suggest that the offer for the takeover bid is about $27bn, which is re-offered to Perrigo after its rejection to the earlier proposal. Mylan is offering

The drug was being tested in children with nonalcoholic steatohepatitis (NASH), which is a liver inflammation caused by a buildup of fat in the liver. The study involved

Both the companies signed license deal in December 2014. The termination starts on 7 January 2016. Anthera will regain all worldwide rights for blisibimod without cost and Zenyaku