BioSpace News Archive

Drug Development

Janssen is Taking a Big Swing at Autoantibody-Driven Diseases

With nipocalimab, Janssen is hoping to take one big swing and knock the power right out of these autoantibodies.

February 27, 2022
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4 min read
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Heather McKenzie
Policy

Invasion of Ukraine Could Curb Availability of Russia’s Sputnik V Vaccine

It is unknown whether tightening economic sanctions will limit Russia’s ability to ship its vaccines to areas that do not have strong manufacturing capabilities.

February 27, 2022
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3 min read
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Alex Keown
Drug Development

Harbour BioMed Announces Approval for Phase I Trial of B7H4x4-1BB Bispecific Antibody in Australia

Harbour BioMed announced that, it has been approved by the Institutional Review Boards to commence phase I trial of its B7H4x4-1BB bispecific antibody in Australia.

February 27, 2022
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2 min read
Policy

GC Pharma Receives Complete Response Letter From the U.S. FDA For ‘ALYGLO’

GC Pharma announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration in response to its Biologics License Application for ‘ALYGLO, 10% Liquid)’.

February 27, 2022
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2 min read
Drug Development

Transcenta Announces First Patient Dosed in Phase IIa Study of Claudin18.2 Monoclonal Antibody TST001 Combined with Cisplatin and Gemcitabine for the First Line Treatment of Biliary Tract Cancer

Transcenta Holding Limited announces the successful dosing of first patient in China Phase IIa Study of TST001, a Claudin18.2 monoclonal antibody, combined with Cisplatin and Gemcitabine for the first line treatment of systemic treatment-naïve locally advanced or metastatic biliary tract cancer patients.

February 27, 2022
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5 min read