Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athersys, Forma, Gensight, Harbour, Humanigen, Pfenex, Remegen, Sinovac, Tetra, Urogen.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ansun, Arvinas, Cytodyn, Gensight, Ico, Mallinckrodt, Oragenics.
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
DUBLIN – Sanofi SA and Glaxosmithkline plc are lending their considerable weight to the urgent global effort to develop a vaccine for COVID-19 by teaming up to develop an adjuvanted recombinant subunit vaccine that will employ technologies from each company. Paris-based Sanofi is contributing its recombinant spike protein antigen and its baculovirus expression system, which is also the basis of its U.S.-licensed influenza vaccine Flublok. London-based GSK is contributing its pandemic adjuvant technology.
LONDON – Companies represented in the expert group brought together by the World Health Organization (WHO) to work on the development of COVID-19 vaccines have signed a pledge to strengthen collaboration and sharing of data.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Alnylam, AVM, Epirium, Grid, Kadmon, KD Pharma, Lifemax.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aldeyra, Amgen, Astrazeneca, Beigene, Bioinvent, Calithera, Cytokinetics, Healios, Madrigal, Outlook.
In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials. But patients still in the studies need to be followed for safety and efficacy, creating challenges for the industry.
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