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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, Accuray, Biocrucible, CM Life Sciences, Daxor, Concordance Healthcare Solutions, Dermtech, Gemspring Capital Management, Grail, Graphenedx, Illumina, Invivoscribe, Koko, Kkr, Longuevue Capital, Lucid Diagnostics, Medical Microinstruments, Nanalysis, One Moon Scientific, Pacemate, Pavmed, RBC Medical Innovations, Relay Medical, Sema4, Starfish Medical, Transcenta, Twist Bioscience, Upscripthealth, Visualdx, Zavation Medical Products.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Ascentage, Astellas, Bluebird, Direct, Genentech, Inozyme, Magenta, Merck & Co., Organicell, Rarestone, Viracta.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aprea, Biomarin, Dicerna, Eureka, Immunomolecular, Lumos, Scilex, Sorrento, Takeda.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.
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