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.
While regulators and policymakers across the world are stressing the need for equitable access to COVID-19 vaccines, therapies and devices, their own policies and regulations may be getting in the way of that goal. The World Trade Organization (WTO) released a list of trade-related bottlenecks July 20 that are hindering access to pandemic-related medical products.
Stock market exuberance, particularly in favor of an innovative industry working to pull the world out of the deadly COVID-19 pandemic, led to drug developers shares surging 30% in 2020. But if one thing is certain, it is this: Markets usually pull back and that is partially why BioWorld’s Drug Developers Index is showing only a 2.06% gain so far this year, in contrast to both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are up 6.28% and 10.96%, respectively.
Japan’s Ministry of Health, Labour and Welfare approved the Regen-Cov (casirivimab/imdevimab, also known as Ronapreve) antibody cocktail for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Ardelyx, Ionctura, Keiferx, Myovant, Octapharma, Sanofi, Swedish Orphan.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Anthos, Biomarin, Bonus, Ionctura, Lineage Cell, Mediwound, Merck, Ose, Rain, Sesen, SK Life, Wave.
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