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The UK’s Drug Safety Research Unit (DSRU), a nonprofit that studies the safety of medicines, has published the first benefit-risk analysis for Gilead Sciences’ antiviral remdesivir, finding that it has a favorable overall profile, although questions remain about the drug’s safety. Read More
As part of a postmarket review, Australia’s Therapeutic Goods Administration (TGA) is reviewing all approved serology-based COVID-19 point-of-care tests to verify their ability to detect SARS-COV-2 antibodies. Read More
AbbVie has entered into a partnership with Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) to develop a monoclonal antibody therapy for COVID-19. Read More
The Association of American Physicians and Surgeons (AAPS) has filed a lawsuit against the heads of the FDA, HHS and the Biomedical Advanced Research and Development Authority (BARDA) over what they call “irrational interference” to limit the use of hydroxychloroquine (HCQ) for treating COVID-19 patients. Read More
Inovio Pharmaceuticals has sued its primary vaccine manufacturer VGXI for alleged breach of contract over production of Inovio’s COVID-19 vaccine candidate. Read More
Thirty-one conservative groups have sent a letter to Congress challenging a proposal by Democrats to limit COVID-19 drug prices by denying patents, exclusivity and intellectual property rights. Read More