While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines.
CSL Ltd. subsidiary CSL Seqirus signed a licensing and development deal with Arcturus Therapeutics Inc. to in-license Arcturus’ late-stage self-amplifying mRNA vaccine platform technology. Arcturus will receive $200 million up front and is eligible to receive more than $1.3 billion in development milestones and over $3 billion in commercial milestones. In addition, it could capture a 40% net profit share for COVID-19 vaccines and up to double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens.
Pfizer Inc.’s bivalent prefusion vaccine for protecting newborns from severe respiratory syncytial virus (RSV) hit one of its two primary endpoints in its phase III study, which was good enough for the company to stop enrollment and plan to submit a BLA to the U.S. FDA by year-end. PF-06928316 is one of six RSV vaccines in active phase III development globally, which includes an Astrazeneca plc-Sanofi SA collaboration plus one from GSK plc. Pfizer’s is the only one developed for infants by way of maternal immunization and for older adults.
Novaccess Global Inc. has announced the approval of its application with the FDA for orphan drug designation for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma and other high-grade gliomas. The company’s therapeutic path involves a unique transformational process, which involves the addition of proprietary substances to create a cocktail for more personalized treatment that substantially increases clinical benefits for patients.
Sinocelltech Group Ltd. has reported positive interim data for two COVID-19 vaccine candidates, SCTV-01C and SCTV-01E, from phase III trials in the United Arab Emirates.
PT Etana Biotechnologies Indonesia secured a series B financing of undisclosed value, led by Chinese investors that include Jack Ma’s Yunfeng Capital and Highlight Capital. The funds will be used to strengthen the company's pipeline and to expand its local manufacturing capacity.
The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
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