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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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’…
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…
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…
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…
A week after topping pre-pandemic highs, the medtech industry’s stocks were brought back down to earth in quick fashion.
MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 89.03 (Sep. 11), marking a -0.3% dip from the 89.29 points registered at the end of the week prior (Sep. 4).
However, the slight dip from week-to-week doesn’t show that, just before the Sep. 4 mark, medtech stocks had reached 93.11 points on Sep. 2, coming in nearly a full point ahead of the pre-pandemic high of 92.32, which the market reached on Feb. 19.
During the week, the index dipped down to 88.22 points, which is the lowest total it has reached since it sat at 87.06 on July 16. By climbing back up to 89.03, the index now represents a -4.4% drop from the Sep. 2 high point and a -3.6% drop from the pre-pandemic high set on Feb. 19.
Meanwhile, the S&P 500 Index saw a -2.5% dip from Sep…
[Photo by Fusion Medical Animation on Unsplash]
China has reportedly begun human testing for a COVID-19 vaccine which utilizes nasal spray instead of an injection.A report in Bloomberg cites a registration in the Chinese Clinical Trial Registry confirming that the nasal spray vaccine candidate developed by Xiamen University, Hong Kong University and Beijing Wantai Biological Pharmacy Enterprise is undergoing Phase I human testing.
Nasal spray vaccines have been developed for influenza and are often used for children and adults who seek alternatives to a needle injection and in this case would add another method for administering the much sought-after COVID-19 vaccine.
Bloomberg said the vaccine candidate is the 10th from China to reach the human testing phase. An NPR report also said some scientists have expressed hope that a vaccine sprayed in the nose would be better suited to stopping the sprea…
From The University of Texas at Austin
Researchers at The University of Texas at Austin are touting an accurate antibody test for COVID-19 with lower costs than those currently in use.
According to a news release, the test, developed in collaboration with Houston Methodist and other institutions, is more accurate than the standard antibody tests in use right now and can handle a much larger number of donor samples at a lower overall cost.
The researchers believe that its near-term use can be for identifying the best donors for convalescent plasma therapy and for measuring how well candidate vaccines and other therapies elicit an immune response. Additional uses down the line include assessing relative immunity in those previously invected by the SARS-CoV-2 virus and identifying asymptomatic individuals with high levels of neutralizing antibodies against the virus.
“This is potentially gam…
From the Theranos case to wearable medical devices, it’s been another busy news week for the medical device industry.
Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:
5. Bardy Diagnostics names new CEOKevin Hykes— who over the years has led companies including Relievant Medical Systems, Metavention and Cameron Health — will take over the corner office at Bardy Diagnostics. Bardy has developed the CAM (Carnation ambulatory monitor) for monitoring cardiac rhythms. Read the full story.
4. Drug companies say they won’t release COVID-19 vaccine until it’s readyExecutives from nine different drug companies announced a pledge to ensure safety with a potential COVID-19 vaccine. “We believe this pledge will help ensure public confidence in the rigorous scienti…
Hologic (NSDQ:HOLX) is up today after its financial outlook for the fourth quarter improved from projections in its third-quarter results from July.
Shares of HOLX were up 3.8% at $62.22 per share in mid-morning trading today.
After reporting a strong third quarter boosted by COVID-19 test sales, the company expected to log adjusted EPS of 95¢ to $1.15 in the fourth quarter, with revenue projected to fall between $925 million and $1.025 billion.
Since the Marlborough, Mass.-based company made those projections on July 29, its diagnostics business has continued to expand its supply chain capacity, boosting revenues with increased production and sales of its COVID-19 tests, Panther instruments and other related products.
Additionally, the company’s breast and skeletal business, along with its surgical segment, have performed slightly above expectations, according to an SEC filing.
With more than 80% of the fiscal fourth quarter complete…
Bank of America analysts say that they are bullish over the medtech industry as surgical procedure recoveries in recent months bode well for the field.
In an analysis published yesterday, BofA said medtech management teams are likely remaining cautiously optimistic amid recovery efforts brough on by the impact of COVID-19, but they are growing in confidence with regard to the quality and durability of demand for their products, with Medtronic’s (NYSE:MDT) recent earnings call and talks with Stryker (NYSE:SYK) suggesting the air of confidence.
Additionally, BofA analysts say that, as innovation pipelines are full, valuations in the industry remain reasonable, there is no drug pricing risk and medtech has outperformed the last three recessions.
Medtronic, Stryker and Baxter (NYSE:BAX) are three companies driving the narrative behind the BofA analysts’ confidence, but they did downgrade Intuitive Surgical (NSDQ:ISRG) from “Buy” to &#…
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…