Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Generex, Immuron, Karyopharm, Molecular Partners, Neoimmunetech, Orchard, Orphazyme, Osmotica, Sanifit, Sorrento.
LONDON – From the start of the pandemic antibodies have been the main focus of attempts to understand the immune response to SARS-CoV-2 and ascertain what it will take for vaccines to be protective.
The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.
Keeping you up to date on recent developments in neurology, including: Phantom-limb pain reduced through brain-computer interface training; Anxiety, depression in COVID-19 patients with loss of smell and taste; HBOT improves cognitive function of older adults.
LONDON – While the pandemic raged, Brexit was simmering on the back burner, but now as infections wane, the industry is turning its attention back to being ready for the U.K. cutting ties with the EU at the end of December.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA, Aptorum, Bio-Thera, Curadigm, Cyclerion, Fairhaven, Liminal, Ocular, Orphazyme, Pharmapark, Takis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Aprea, Celltrion, Janssen, Phasebio, Sinopharm.
The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
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