More than 20 world leaders have called for an international treaty for pandemic preparedness to protect the world from future health crises. Backed by the World Health Organization, the treaty would “dispel the temptations of isolationism and nationalism” in the event of another crisis such… Read More »World leaders call for international pandemic preparedness treaty
Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial… Read More »Novavax in talks with FDA over quick approval for COVID-19 shot
Novavax says it’s building up its manufacturing capacity now to be ready to ship Covid-19 vaccine globally as emergency authorizations are granted in coming months. The company expects to seek FDA authorization in the second quarter.
Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan
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.… Read More »Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan
Novavax has signed a deal to provide 1.1 billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available… Read More »Novavax provides 1.1 billion COVID shots to global vaccine drive
The UK has reached a major landmark with its COVID-19 vaccination programme, with more than 10 million people receiving their first shot. After almost a year of restrictions to prevent the virus spreading, there is now hope that normal life may begin to return as… Read More »UK reaches 10 million landmark with COVID-19 vaccination programme
Novavax’s COVID-19 vaccine could be added to the UK’s growing arsenal of shots against the disease after it showed 89.3% efficacy in a late-stage trial. The shot is the first to show efficacy against the new variant found in the UK which accounted for around… Read More »Novavax’s COVID-19 shot effective against UK strain
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… Read More »PharmaShots’ Key Highlights of Fourth Quarter 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-… Read More »PharmaShots Weekly Snapshots (Nov 09-13, 2020)
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… Read More »Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19
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… Read More »PharmaShots Weekly Snapshot (Nov 02-06, 2020)
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.… Read More »Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19
The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has… Read More »UK government signs contract for COVID-19 challenge trial
Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s… Read More »Is COVID the Rx for the Pharmaceutical Industry’s Reputation?
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… Read More »PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)
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… Read More »Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat 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… Read More »SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine
The UK is to buy millions more doses of potential coronavirus vaccines from Johnson & Johnson and Novavax, with the latter expanding its manufacturing operation in the country. Johnson & Johnson’s Janssen pharmaceuticals unit will supply an initial 30 million doses on a not-for-profit basis… Read More »UK signs coronavirus vaccine deals with J&J and Novavax
Novavax’s COVID-19 vaccine produced higher levels of neutralising antibodies than produced by recovered patients in an early trial, paving the way for a phase 3 trial and potential approval by year-end. The US biotech is gearing up to produce two billion doses of the vaccine… Read More »Novavax says COVID-19 vaccine could be approved by year-end
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
The company is running a Phase I/II study that started in May in Australia and plans to open a Phase III study of its vaccine candidate, NVX-CoV2373, that will enroll up to 30,000 participants starting in the fall.