Biotech | October 18, 2021
U.S. FDA advisory committee recommends J&J booster dose
U.S. FDA to decide whether to authorize a booster dose in the coming days
U.S. FDA to decide whether to authorize a booster dose in the coming days
If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19
The company has already received the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D to be administered in three doses on August 20
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan
CuraTeQ Biologics is on track for filing a second oncology biosimilar
Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose
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Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test
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