Tags : Novavax

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

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

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373

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

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

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

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses

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

Novavax Initiates P-III Study of its COVID-19 Vaccine in the

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

Weekly Snapshot Aug 10 – 14, 2020

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

Novavax Collaborates with UK Government to Supply 60M Doses of

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

SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19

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

Insights+ COVID-19 Deals (Part III): Biopharma and Govt. Institutions

The emergence of the coronavirus SARS-CoV-2 and the COVID-19 pandemic has spurred global healthcare and life sciences companies, as well as government agencies, to partner at unprecedented speed to develop vaccines, treatments, and kits. This article covers the last six months of deal data provided by Chris Dokomajilar of DealForma. During the last six months (up […]Read More

Novavax Initiates P-I/II Study of NVX‑CoV2373 Vaccine Against COVID-19

Shots: The company reported the enrollment of the first participants in a P-I/II clinical study of its vaccine candidate, NVX‑CoV2373, developed utilizing nanoparticle technology. The vaccine includes Novavax’ Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing Abs with its expected preliminary immunogenicity and safety results in Jul’2020 The P-I-part evaluates the […]Read More