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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3a-diagnostics, Agilent Technologies, Clx Health, Guided Therapeutics, Health Decisions, Micronoma, Novocardia, Ortho Regenerative Technologies, Pacific Biosciences, Premier Research, Quest Diagnostics, San Omniome, Shandong Yaohua Medical Instrument, Terumo Europe, Theator, Thomas Scientific, Xphyto Therapeutics.
New preclinical data from Immunome Inc. gets the company closer to the clinic for studying its three-antibody cocktail’s effect on SARS-CoV-2. “We will file an IND this quarter and get into the clinic,” Immunome’s CEO, Purnanand Sarma, told BioWorld. “Since the number of cases is rising, unfortunately, we think a clinical study could be conducted reasonably quickly.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Almirall, Aquestive, Astrazeneca, Bluerock, Elucida, G1, Kadmon, Kyowa Kirin, Lyndra, Merck & Co., Oblato, Receptor Life Sciences, Sinovac, Xenikos, Yisheng.
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