Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta Group, Medtronic, Opgen, Orasure Technologies.
The European Commission unveiled its third alternative to providing global access to COVID-19 vaccines and treatments just ahead of the June 8 meeting of the World Trade Organization’s Council for Trade Related Aspects of Intellectual Property Rights and the start of the G7 summit.
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acepodia, Adamis, Adhera, Argenx, Astrazeneca, C4, Cilag, Equillium, Immune, Janssen, Luye, Medicinova, Medison, Mediwound, Melior, Moderna.
Stemirna Therapeutics Co. Ltd., which specializes in mRNA technology, said it raised nearly $200 million to speed up the clinical study of its COVID-19 vaccine candidate, SW-0123. It is in phase I study in China and preclinical data have been published in Nature.
LONDON – A new U.K. study indicates the Pfizer Inc./Biontech SE COVID-19 vaccine is less effective against the India variant of the SARS-CoV-2 virus that was designated as of global concern by the World Health Organization (WHO) on May 10.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ortho Regenerative Technologies, Pharmaessentia USA, Pharming Group, Regeneron, Visen.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Acadia, Advaccine, Albireo, Alzheon, Beyondspring, Galapagos, Gilead, Mirum, Point, Precision, Valbiotis, Valneva, Vincerx, Virios, Zynerba.
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