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QSV Biologics, Ltd. and Critical Biologics Corp. Sign 2nd Contract for cGMP Manufacture of Plasma Gelsolin

QSV Biologics, Ltd. and Critical Biologics Corp. Sign 2nd Contract for cGMP Manufacture of Plasma Gelsolin

CMC Biologics A/S Announce Manufacturing Agreement with Symphogen A/S

CMC Biologics A/S announced that it has entered into an agreement with Symphogen A/S for process development and cGMP manufacture of an undisclosed polyclonal antibody product candidate from Symphogen's development pipeline. Terms of the agreement were not disclosed.

Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema

Dyax Corp. announced the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax's lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). Dyax has requested Priority Review, which, if granted, would set a target date of six months from receipt of the completed submission for the FDA to take action on the application. Priority designation is intended for those products that address unmet medical needs. DX-88 has previously been granted Orphan Drug designation as well as Fast Track status by the FDA.

Jackie Ying

"Cell culture is conventionally performed on a flat surface such as glass slides," said Ying. "It is an essential process in biological and medical research and is widely used to process cells, synthesize biologics and develop treatments for a large variety of diseases.

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