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Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.
Coronavirus Notebook: EMA Issues New COVID-19 Vaccine Safety Updates, Australia Assesses Comirnaty In Younger Children
The European regulator has warned of the risk of myocarditis, pericarditis and anaphylaxis with Novavax’s COVID-19 vaccine, Nuvaxovid, while Switzerland has updated its guidance on the use of COVID-19 medicines against virus variants. Iconovo has received funding to develop its ICOone nasal inhaler for use in pandemics in resource-poor settings.
Among the strong performers, Hanmi benefitted from growth for in-house-developed metabolic disease drugs and China cold syrup sales and Daewoong was boosted by exports of botulinum toxin, while Boryung reported record quarterly sales helped by its flagship antihypertensive.
A roundup of key regulatory and policy developments in the Asia-Pacific in the first half of the year reveals broad developments across the region's diverse markets, although there seemed to be a common thread - a renewed focus on infectious diseases amid the lingering impact of the pandemic and the emergence of new threats.
- Drug Delivery
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
- CPL Biologicals Pvt. Ltd. (Joint Venture with Cadila)
- Isconova AB
- Novavax AB