Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis
CStone granted the exclusive rights to Hengrui for research, development, registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in the Greater China region
Premas Biotech is the developer of the technology for the Covid-19 vaccine and a shareholder in Oravax Medical
Dicerna develops RNAi-based therapies to selectively silence genes that cause or contribute to disease
It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus
The final data from the trial showed sotrovimab reduces hospitalisation and risk of death by 79% in adults with mild-to-moderate Covid-19 who are at high risk of progression to severe disease
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic Covid-19, with no severe disease or deaths
If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2
Launching in 2022, its availability will be expanded to the global market
The interim data combines three mRNAs into one therapy injected directly into the tumour
The company expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
Bioanalytical approach to accelerate development efforts in the identification of compounds that can treat chlorine or sulfur mustard injuries
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo
The new manufacturing facility will be built at a subsidiary of Adcock Ingram and will commence operation in March 23
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO
The product is synthetically developed as compared to the current process of drawing the same from blood plasma and is backed by a granted global patent
The collaboration will combine Metagenomi’s next-generation CRISPR-based and other novel gene editing systems with Moderna’s mRNA and LNP technologies
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