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Regulatory NEWS
The European Society for Medical Oncology (ESMO), a pan-European body representing European oncologists, has warned that retrospective clinical cancer research could be outlawed in Europe if the European Parliament's legislative proposals on data protection are not overturned.

The FDA is a stone's throw away from approving its first official biosimilar – a filgrastim follow-on developed by Sandoz International GmbH. Sandoz reported Thursday that the agency accepted its 351(k) biologics license application (BLA) for its biosimilar of Amgen Inc.'s Neupogen.

SALIX: ACCESS FOR PATIENTS LATER THIS YEAR
As expected, the FDA cleared for marketing Wednesday recombinant human C1 esterase inhibitor Ruconest (conestat alpha) for use in acute attacks of hereditary angioedema (HAE), news that should bring an immediate lift to developer Pharming Group NV.
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