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Cofact is Sanquin’s prothrombin complex of blood factors II, VII, IX and X which is currently in MRP (mutual recognition procedure) registration, in a number of Crucell’s key

Australian Drug Evaluation Committee’s (ADEC) recommendation for approval will be forwarded to the Therapeutic Goods Administration (TGA) for ratification. The TGA generally supports the recommendations of the ADEC

This acceptance of this investigational new drug (IND) application will permit Chelsea to commence its pivotal Phase III clinical trials in neurogenic orthostatic hypotension (NOH). Chelsea plans to

Epix said that the purchase price would be at $3.10 per share for expected gross proceeds of approximately $16.3 million before payment of placement agent commissions and offering

These data are from post-hoc analyses of two Phase III pivotal trials investigating Orencia: AIM (abatacept in inadequate responders to methotrexate) and ATTAIN (abatacept trial in treatment of

The project, entitled improved bladder cancer therapy with recombinant BCG, aims to improve the safety and efficacy of an existing immunotherapy, BCG, that can have difficult side effects

The acquisition will be implemented through an issue in kind to Biolipox’s shareholders of 8,556,895 Orexo shares. Orexo and the principal shareholders in Biolipox have reached an agreement

The lower-strength Kaletra tablets will be available in the US from November. Approval of this lower-strength Kaletra tablet represents an important step in Abbott’s ongoing commitment to the

The European Medicines Agency’s (EMEA) Orphan Medicinal Product Designation is designed to promote the development of drugs which may provide benefit to patients suffering from rare diseases identified