Novavax

Amnesty says COVID jab producers are causing human rights crisis

Amnesty International has slammed the six pharma companies behind the bulk of COVID-19 vaccine supplies of for not agreeing to waive their intellectual property rights and share the technology behind them. The charity says AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax, and Pfizer are fuelling an “unprecedented human rights crisis” as a result and their …

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PharmaShots Weekly Snapshots (June 14 – 18, 2021)

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, …

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Novavax’s COVID-19 Vaccine Demonstrates 90.4% Efficacy in P-III PREVENT-19 Study

Shots: The P-III PREVENT-19 study involves assessing the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant vs PBO in 29,960 participants aged ≥18yrs. across 119 sites in the US and Mexico The study demonstrated 100% protection against mod. & sev. disease, 90.4% efficacy overall, and met the 1EPs. The study also showed 93% efficacy …

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Novavax Covid-19 vaccine shows 90% efficacy, protection against variants

Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.

Novavax unveils phase 3 COVID jab data, but has it missed the boat in US?

The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme. Novavax’ price spiked 9% after the data were announced today, but fell back just as quickly, despite the company’s assertions …

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UK booster trial will test value of third COVID jab dose

All seven COVID-19 vaccines ordered by the UK government will be tested in a new trial that will see whether they can be used as a third booster dose to protect against new variants.  The Cov-Boost trial is thought to be the first in the world to try to generate data on the value of …

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Novavax delays COVID vaccine filings until Q3

Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are due in the third quarter. The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data. …

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PharmaShots Weekly Snapshots (May 03 – 07, 2021)

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + …

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Novavax Reports the Pediatric Expansion for P-III Clinical Trial of NVX-CoV2373 Against COVID-19

Shots: The company has reported the expansion of P-III PREVENT-19 pivotal trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 vs PBO in ~3,000 adolescents aged 12-17yrs. against COVID 19 across 75 sites in the US Patients will receive two doses of either NVX-CoV2373 or PBO given 21 days apart and participants will be …

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UK Vaccine Taskforce head lifts lid on Novavax deal

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce.  Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in …

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World leaders call for international pandemic preparedness treaty

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 as COVID-19. In a commentary backed by the 24 leaders, …

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Novavax in talks with FDA over quick approval for COVID-19 shot

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 in the UK, which could set up a potential Emergency …

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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. after the second vaccination with primary results expected in CY2021. …

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Novavax provides 1.1 billion COVID shots to global vaccine drive

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 to poorer countries. This week UK prime minister Boris Johnson …

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UK reaches 10 million landmark with COVID-19 vaccination programme

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 data collected separately in Israel showed that vaccination also helps …

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Novavax’s COVID-19 shot effective against UK strain

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 half of cases in the phase 3 study. Efficacy against …

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PharmaShots’ Key Highlights of Fourth Quarter 2020

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 …

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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 …

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Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

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 …

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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, …

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Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

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 …

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UK government signs contract for COVID-19 challenge trial

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 signed the contract with the UK government to develop the …

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Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

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 response to this global public health crisis be the Rx …

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PharmaShots 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, …

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Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

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 …

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

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 …

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UK signs coronavirus vaccine deals with J&J and Novavax

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 for emergency use in the pandemic, with an option for …

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Novavax says COVID-19 vaccine could be approved by year-end

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 in 2021 following the results from its vaccine candidate, codenamed …

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FDA guidance eases some Covid-19 vaccine concerns, but others remain

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.