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
The company said that it is the first integrated insulin therapy to display real-time continuous glucose readings and trend graphs, allowing patients to make immediate self-management decisions to
Under the terms of the agreement, VaxGen shall issue, and the holders of Raven Series D preferred stock shall receive, in a tax-free transaction, approximately 32 million shares
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