The latest global regulatory news, changes and updates affecting biopharma, including: First thrombosis incident reported in Australia; FDA offers guidance on ANDAs during pandemic; FDA revises Moderna EUA; Fed Circuit’s indefinite ruling stands; BMS settles Medicaid rebate claims; GAO refuses to reconsider VA challenge.
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?
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