J&J launches fourth large-scale COVID-19 vaccine trial

Johnson & Johnson (NYSE:JNJ) has begun enrollment of adult volunteers for a fourth Phase 3 clinical trial of a COVID-19 vaccine candidate.

The National Institutes of Health announced today that J&J’s Janssen Pharmaceuticals COVID-19 vaccine candidate (JNJ-78436725) has begun the Phase 3 trial to evaluate if it can prevent symptomatic COVID-19 after a single dose regimen.

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Canada lining up millions of doses of COVID-19 vaccines

Sanofi (NYSE:SNY), GlaxoSmithKline (NYSE:GSK) and Moderna (NSDQ:MRNA) have all agreed to supply Canada with a total of more than 90 million doses of a COVID-19 vaccine.

Beginning in 2021, Government of Canada is set to receive up to 72 million doses of an adjuvanted COVID-19 vaccine from Sanofi and GSK, while the country also increased its confirmed order commitment with Moderna to 20 million doses of its mRNA-1273 COVID-19 vaccine candidate.

Sanofi and GSK initiated a Phase 1/2 study on Sept. 3, enrolling 440 subjects with the first results anticipated for early December 2020 with eyes on a pivotal Phase 3 study before the end of the year, lining it up for a regulatory approval request in the first half of 2021.

Both companies have vaccine manufacturing sites in Canada which will contribute to the vaccine production there and elsewhere, as they landed a $2.1 billion contract from the Trump administration for the vaccine candidate in July.

“Today’…

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BARDA awards $12.9M to Ortho Clinical for coronavirus antigen test

Ortho Clinical Diagnostics announced that it received a nearly $12.9 million award from BARDA to support the development of its COVID-19 antigen test.

Raritan, N.J.-based Ortho Clinical Diagnostics and the Biomedical Advanced Research and Development Authority (BARDA) are working together under a new contract as part of the government’s ongoing COVID-19 medical countermeasure development efforts, according to a news release.

BARDA awarded Ortho $12.85 million in support of its SARS-CoV-2 antigen test for the rapid detection of the virus causing COVID-19. That funding will also go toward the pursuit of regulatory clearance for Ortho’s total and IgG antibody tests that were granted FDA emergency use authorization (EUA) in April.

Ortho’s total antibody test is designed to detect all COVID-19-related antibodies, while the IgG test detects the IgG antibody which appears in the later stages of infection and remains elevated even after recover…

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Siemens, Novartis team up on MS drug development

Siemens Healthineers (ETR:SHL)  and Novartis (NYSE:NVS) have agreed to jointly design, develop and commercialize diagnostic tests for therapeutic products across Novartis’ therapeutic pipeline, the companies announced today.

The first project will be a serum neurofilament light chain (NfL) immunoassay for patients with multiple sclerosis (MS) and other neurological diseases.

NfL is a highly specific biomarker for nerve cell injury measured in cerebral spinal fluid and blood. Blood NfL levels have been reported to change in a variety of serious neurological conditions, including MS, according to a 2018 study published in Nature.

This collaboration will use Siemens Healthineers’ expertise in the development of clinical diagnostic tests that can run on its ADVIA Centaur and Atellica immunoassay platforms, designed for use in hospitals, reference laboratories, and specialty laboratories. Siemens Healthineers will also be global distributor of the immunoassay…

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Illumina may buy back Grail

Illumina (NSDQ:ILMN) may acquire Grail for more than $8 billion — four years after it spun out the cancer detection startup.

That’s according to a Bloomberg report out yesterday, which cited people familiar with the matter.

Analysts told Bloomberg that the acquisition would put Illumina — a giant in the DNA sequencing space — in direct competition with its customers. But the potential of Grail’s early cancer detection tech may be too good for Illumina to pass up.

Grail has been preparing for an IPO on the Nasdaq, where it would trade under the symbol GRAL. It plans to commercially launch its Galleri early cancer detection test next year.

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Report: U.S. should have enough COVID-19 vaccine in Q3 2021, CDC head tells Senate panel

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC.

Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to inoculate all Americans, the network reported.

“If you’re asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at third … late second quarter, third quarter 2021,” Redfield told the U.S. Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is p…

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AstraZeneca resumes COVID-19 vaccine trial

AstraZeneca (NYSE:AZN) has resumed its COVID-19 vaccine trial in the U.K. following confirmation from the Medicines Health Regulatory Authority (MHRA) that it was safe to proceed.

The news of the trial resumption, announced Sept. 12, came six days after a voluntary pause so that an independent committee could review safety data surrounding a single event of an unexplained illness. The person with the illness was part of the Phase III  trial for the AZD1222 vaccine AstraZeneca is developing in collaboration with Oxford University.

Now that the trial has resumed, AstraZeneca declined to disclose further information.

AstraZeneca is one of nine drug companies that have pledged to ensure safety with a potential COVID-19 vaccine and only submit for approval or emergency use authorization (EUA) after demonstrating safety and efficacy through a Phase 3 clinical study. The companies made the pledge amid worries that there is political pressure in the U.S. to rele…

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BioAscent spending £1M to boost drug discovery service offering

BioAscent (Newhouse, U.K.) recently announced that it will spend £1 million ($1.3 million) on new instrumentation and equipment.

The investment is meant to further enhance the company’s offerings in integrated drug discovery and compound management.

The new instrumentation will include a FLIPR Penta screening system and a Biacore 8k Surface Plasmon Resonance (SPR) system, as well as a new workstation for plate set-up during compound management, and updated IT infrastructure.

“We have the experience and expertise in the team to support a wide range of drug discovery projects, and we are committed to delivering the highest quality research, cost-effectively for our clients. Our investment in new systems and ensuring that the team has the best instrumentation at their disposal is a reflection of this commitment,” BioAscent CEO Paul Smith said in a Sept. 3 news release.

 

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Pfizer touts non-human preclinical trial results for COVID-19 vaccine candidate

Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials.

The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release.

In a viral infection model, macaques received two injections with 100 µg of the vaccine candidate and macaques that received saline control injections were challenged 55 days after the second immunization with a high viral inoculum of about 1 million plaque-forming units of SARS-CoV-2. Immunization with BNT162b2 reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while the control group demonstrated evidence of viral RNA.

Among the anti-viral effects demonstrated by the vaccine were concomitant…

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AstraZeneca puts COVID-19 vaccine trial on hold

AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness.

The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine being developed in collaboration with Oxford University.

“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” an AstraZeneca spokesperson told Drug Discovery & Development in a statement. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the t…

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Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE)  and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

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LabCorp launches flu-COVID diagnostic combo

Laboratory Corporation of America (NYSE:LH) announced today that it launched its COVID-19, influenza A/B and RSV diagnostic combo.

The single-panel test is designed to detect multiple types of infections including the novel coronavirus, the flue and respiratory syncytial virus (RSV), helping doctors diagnose patients and inform decisions for treatment options.

Burlington, N.C.-based LabCorp’s testing method is aimed at easing the strain that could be put on the healthcare system in the U.S. if there is a significant flu/RSV season in which the symptoms are similar to COVID-19 and other respiratory viruses, according to a news release.

LabCorp is offering the test through doctors, hospitals and other authorized healthcare providers in the U.S., while the company has submitted an application to the FDA to offer the combined test through its Pixel by LabCorp collection kit to add convenience and accessibility.

The Pixel by LabCorp at-home test …

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