Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos. after the second vaccination with primary results expected in CY2021. […]Read More
The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated […]Read More
Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of […]Read More
Shots: The US FDA has granted FT designation to NVX-CoV2373 which is currently in late-phase clinical development. Novavax expects to initiate pivotal P-III study in the US & Mexico by the end of Nov’2020 The company’s ongoing P-lll trial in the UK to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 is expected to be […]Read More
AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke Novo Nordisk to Acquire Emisphere Technologies for $1.8B Published: Nov 6, […]Read More
Shots: Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per […]Read More
Shots: Novavax has initiated a P-III study assessing the efficacy, safety, and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks. Half the participants will receive two IM injections of a vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 […]Read More
1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children 2. The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer Published: Aug 07, […]Read More
Shots: Novavax will supply ~60M doses of its COVID-19 vaccine to the UK government for P-III study evaluating the efficacy of NVX-CoV2373 in ~9,000 adults aged 18-85yrs. in the UK. The trial is expected to initiate in Q3’20 Novavax will expand its collaboration with FUJIFILM Diosynth, which will manufacture the antigen component of NVX-CoV2373 from […]Read More
Shots: SK bioscience signs a development and supply agreement for Novavax’ NVX-CoV2373 to supply it globally including the COVAX facility. SK bioscience will manufacture the vaccine antigen component for use in the final drug product SK bioscience will utilize its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at […]Read More
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