The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
The positive safety review from the DSMB enables the trial to move forward as planned, with an estimated completion date in December 2023
Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024
Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
This innovative product eliminates two manufacturing steps and simplifies equipment setup
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
The increased drug load enabled by the nanoformed particles also allows smaller implants with sustained release properties to be developed.
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions
The inspection closed with zero observations
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