As the COVID-19 pandemic continues to impact the FDA’s inspection program, U.S. lawmakers are worrying about what that may mean for future drug approvals.
“We are . . . concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections,” the bipartisan leadership of the House Energy and Commerce Committee and its Health Subcommittee said in a July 22 letter to acting FDA Commissioner Janet Woodcock.
Shionogi & Co. Ltd. started a phase I trial in Japan for S-217622, its orally administered 3CL protease inhibitor for treating COVID-19. Should the drug be approved by Japanese regulators, it would be the first Japanese-developed COVID-19 treatment to be approved in the country.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Moderna, Rhythm.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Acticor, Adverum, Aurion, Denali, F-star, Immunicum, Innovent, Kyowa Kirin, Mediwound, NGM, Synlogic.
Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse.
LONDON – An attempt to develop an alternative sampling method to replace unpleasant nasopharyngeal swabbing in COVID-19 diagnosis has failed, with researchers at Owlstone Medical Ltd. finding the number of viral particles that can be collected from the breath of hospitalized patients is below the limit of detection. Owlstone is a specialist in collecting and analyzing breath samples to look for volatile organic compounds that are biomarkers of disease, such as lung cancer and asthma.
While 2020 was clearly a busier year for grants and nonprofit deals with biopharma companies, pandemic efforts continue to drive the activity in these two areas. Through mid-July, there have been 204 grants valued at $1.75 billion, and 516 bio/nonprofit deals worth more than $8 billion, up from $4.66 billion only a month ago.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antares, Ascletis, Biovaxys, Erytech, Index, GBT, Humanigen, Merck & Co., Pfizer, Radius, Rational Vaccines, Sorrento.
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