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.


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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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6 Georgia residents suing Sterigenics, BD over ethylene oxide exposure

Ethylene oxide (Image from Sterigenics)

The first six of what attorneys said could be more than 100 lawsuits were filed recently in Georgia against Sterigenics and Becton Dickinson (NYSE:BDX) by people who have lived, worked or attended school near those companies’ medical device sterilization plants.

The plants use ethylene oxide (EtO) to sterilize millions of devices per year and reportedly have emitted  thousands pounds of the gas into the atmosphere over the past. The U.S. Environmental Protection Agency named EtO a Level 1 carcinogen in 2016. Two years later, the EPA’s National Air Toxics Assessment identified 12 areas of the country with elevated levels of EtO emissions and associated cancer risk, including the areas of Georgia where BD and Sterigenics have EtO plants.

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FDA grants Verily EUA for pooled COVID-19 testing

The FDA has granted Google’s (NSDQ:GOOGL) Verily emergency use authorization (EUA) for its pooled COVID-19 testing.

In a letter to the company dated yesterday, the FDA confirmed the EUA status for the qualitative test for detecting nucleic acid from SARS-CoV-2 in respiratory specimens procured through nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabbing.

The test also can be used for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples that contain up to 12 individual specimens collected by a healthcare provider using individual vials.

In a blog post, Verily said the continually growing demand for testing amid the return to schools and workplaces highlight the need for scaled testing efforts, which can be made more efficient by pooling samples.

According to the FDA letter, the test processing is limited to only Verily at its San Francisco headquarters, at which the company last month established a CLIA-certified l…

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Biorez raises $3.5M for its BioBrace tech

Tendon and ligament repair technology developer Biorez announced today that it raised $3.5 million in a seed financing round.

New York Angels led the financing round, while Connecticut Innovations, Pritzker Vlock Family Office, Brainchild Holdings and The Vertical Group also participated, according to a news release.

The New Haven, Conn.-based company develops the BioBrace implant, which is comprised of a highly porous collagen sponge reinforced with bioresorbable microfilaments with the intention of augmenting and reinforcing a wide range of tendon and ligament procedures, including rotator cuff repair and ACL reconstruction.

Biorez said that the latest financing round adds to a previously raised $3.5 million, bringing its total funding at the moment to $7 million.

“Our vision is to help patients return to normal activity sooner and safer,” Biorez president & CEO Kevin Rocco said in the release. “BioBrace has the potent…

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FTC to refund Neurometrix consumers $3.9M in false ad case

NeuroMetrix’s Quell 2.0 [Image courtesy of NeuroMetrix]

The Federal Trade Commission announced that it is refunding NeuroMetrix (NSDQ:NURO) consumers nearly $3.9 million after false advertising.

NeuroMetrix marketed its Quell transcutaneous electrical nerve stimulation device as a clinically proven and FDA-cleared treatment for widespread chronic pain relief when placed below the knee, according to the FTC, which said that the company lacks scientific evidence to support the pain relief and clinical proof claims.

Waltham, Mass.-based NeuroMetrix and its CEO Shai Gozani agreed to pay $4 million to the FTC under an order settling the charges, supplying the money for refunds and agreeing to stop making the allegedly deceptive claims.

NeuroMetrix has been marketing the device since 2015 and last year turned to artificial intelligence to better tailor Quell treatments.

With the settlement f…

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