Following the company’s COVID-19 manufacturing misstep, Emergent Biosolutions Inc. continued its struggle to rebalance as top-line data from a phase III study it participated in failed to hit its primary endpoints with statistically significant results. The data showed that adding anti-SARS-CoV-2 hyperimmunoglobulin to standard of care, inclusive of remdesivir, for hospitalized adult COVID-19 patients with symptoms for less than 12 days failed to provide clinical benefit when compared to standard of care plus placebo. The global, multicenter double-blind, placebo-controlled randomized study assessed the safety and efficacy of four immunoglobulin candidates, the SARS-CoV-2 immune globulin intravenous (human) (COVID-HIG) plus standard of care.
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
Keeping you up to date on recent developments in neurology, including: DBS shows promise in treating OCD patients with comorbidities; COVID-19-associated seizures linked to higher risk of death; Antibodies could make things worse in neurodegeneration; Ultrarare variants give insights into schizophrenia.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nano-X Imaging, Quidel.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Jemincare, Kite, Moderna, Ose, Regeneron, Tetra.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Claritas, Fusion, GSK, Ipsen, Moderna, Nkmax, Sinovac, Ximedica.
TORONTO – “There’s no magic pill that helps patients with concussion except physical activity,” Ashleigh Kennedy, CEO of Neurovine Inc. told BioWorld. But how does a patient in rehab know when to put on the brakes if they’re working too hard physically or mentally?
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Becton Dickinson, Bluestar Genomics, Inspire.
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