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What are the top COVID-19 vaccine candidates?

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

As of yesterday, five COVID-19 vaccine candidates had begun Phase III clinical trials as they seek to determine the safety and efficacy of their formulas.

Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times.

With the U.S. alone topping 200,000 COVID-19 deaths this week and continued pressure to deliver a safe and effective vaccine, these companies and several others are working very quickly to make a vaccine that meets regulatory standards. Seven pharma companies have received funding for vaccine development and…

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Novavax launches Phase 3 COVID-19 vaccine trial in UK

Novavax (NSDQ:NVAX) today announced that it has begun its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate, NVX-CoV2373.

The trial is underway in the UK, in partnership with the UK government’s Vaccines Taskforce. Gaithersburg, Md.-based Novavax said it expects to enroll up to 10,000 individuals between 18 and 84  years of age, with and without relevant comorbidities, over the next four to six weeks and to make its UK study protocol public “in the coming days.”

“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” said Novavax R&D president Dr. Gregory M. Glenn, M.D. in a news release. “The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful…

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Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.

AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety.

U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in collaboration with Oxford University.

Earlier this month, AstraZeneca voluntarily paused its trial after 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 candidate. The UK trial has since resumed, but the U.S. study remains paused.

“Look at the AstraZeneca program, Phase 3 clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical …

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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.

Get the full story at our sister site, MassDevice.

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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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Orthofix names new global extremities president

Orthofix (NSDQ:OFIX) announced that it appointed Paul Gonsalves as the president of its global extremities business.

Gonsalves joins Lewisville, Texas-based Orthofix after previously serving as chief commercial officer at Integra LifeSciences (NSDQ:IART). He also served as senior VP of enterprise sales and corporate marketing at the medtech company.

Before his roles at Integra, Gonsalves served as senior VP and chief transformation officer with AccentCare and held the role of VP and GM of primary care at Novartis (NYSE:NVS), among a series of other roles including a handful at General Electric Healthcare (NYSE:GE).

In his new role, Gonsalves will also serve on the company’s executive leadership team while reporting to Orthofix president and CEO Jon Serbousek.

“Paul brings to Orthofix more than 30 years of industry experience and proven leadership that will both complement and strengthen our exceptional extremities management team,” Serbousek…

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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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Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke

Johnson & Johnson’s Cerenovus recently announced it has launched its new stroke solutions platform that includes three devices for clot removal procedures.

The three devices are designed to aid physicians in performing mechanical thrombectomy procedures. The devices include the Cerebase DA Guide Sheath, Cerenovus Large Bore Catheter and Embotrap III Revascularization Device.

Get the full story on our sister site, Medical Tubing + Extrusion.

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BD has a serious recall of some Alaris System infusion pumps with stuck keys

The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind.

Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between April 12, 2017 and June 25, 2020. A total of 305,526 devices have been recalled in the U.S., according to an FDA release.

BD is recalling the Alaris PC unit and the PC unit front case with keypad replacement kits because the keypad may have one or more keys in the keypad that become unresponsive or stuck, which could lead to an infusion delay or prevent clinicians from changing the fluid or medication infusions on the affected device.

Use of the affected Alaris infusion pump units could cause serious adverse events, including death, although no deaths have been reported to date. So far, there have been 1,186 reported complaints about …

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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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B-Temia wins FDA clearance for mobility exoskeleton

B-Temia’s Keeogo system (Image from B-Temia)

B-Temia announced today that it received FDA 510(k) clearance for its Keeogo Dermoskeleton human mobility system.

Short for “keep on going,” Keeogo is a lower-limb-powered human mobility device with Dermoskeleton lightweight exoskeleton technology that provides what the Quebec City-based company describes in a news release as a “true human-machine interface.”

The Keeogo Dermoskeleton is designed to detect, respond to and support an individual’s movements with advanced software and motorized assistance. Based on individual needs, it offers mobility assistance, including complimentary knee strength and movement cues.

B-Temia’s system is intended for use by stroke patients who fit the user assessment criteria in rehabilitation settings under the supervision of healthcare professionals.

“The work we …

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B-Temia wins FDA clearance for mobility exoskeleton

B-Temia’s Keeogo system (Image from B-Temia)

B-Temia announced today that it received FDA 510(k) clearance for its Keeogo Dermoskeleton human mobility system.

Short for “keep on going,” Keeogo is a lower-limb-powered human mobility device with Dermoskeleton lightweight exoskeleton technology that provides what the Quebec City-based company describes in a news release as a “true human-machine interface.”

The Keeogo Dermoskeleton is designed to detect, respond to and support an individual’s movements with advanced software and motorized assistance. Based on individual needs, it offers mobility assistance, including complimentary knee strength and movement cues.

B-Temia’s system is intended for use by stroke patients who fit the user assessment criteria in rehabilitation settings under the supervision of healthcare professionals.

“The work we …

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Varian names new president & COO among other personnel changes

Varian Medical Systems (NYSE:VAR) today announced a trio of personnel changes including the appointment of a new president and COO.

Effective Oct. 5, 2020, current Varian Oncology Systems president Chris Toth will take over the newly created roll of president and COO. As a result, current senior VP of global operations Kevin O’Reilly will take over as president of Varian Oncology Systems and VP of revenue operations Stephanie Foster will become senior VP of global supply chain operations.

“This announcement is a testament to the deep and diverse bench of talented leaders we have at Varian, as well as a reflection of our commitment to realizing our vision and strengthening our support for Varian’s customers and their patients,” Varian CEO Dow Wilson said in a news release. “I’m thrilled to congratulate Chris, Kevin and Stephanie on their expanded leadership roles, and I’m confident that they will ensure our entire team is well-positioned to build on Varian…

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Cala Health touts results of real-world tremor study

Cala Health today touted data demonstrating that its Cala Trio therapy is safe and effective in improving essential tremor in patients.

Burlingame, Calif.-based Cala Health said in a news release that the data for the wearable technology came from use at home, unsupervised and under real-world conditions, further validating the results reported in the Prospect study nearly one year ago.

Cala Health reported the results at the International Parkinson and Movement Disorder Society’s MDS Virtual Congress 2020, being held from Sept.12 to Sept. 16.

The data covered 44 patients using Cala Trio for symptomatic tremor relief in hand tremors over three months of unsupervised home use. Tremor severity was quantified through tremor power, which was collected through motion sensors and assessed before and after each of the first 40 therapy sessions and every subsequent seventh session.

According to Cala Health, 93% of patients experienced at least a 50% reduc…

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Hologic launches $950M private offering

Hologic (NSDQ:HOLX) announced today that it launched a private offering worth $950 million in senior notes due in 2029.

Marlborough, Mass.-based Hologic said in a news release that it plans to use the proceeds collected from the offering, along with available cash, to refinance its existing 4.375% senior unsecured notes due in 2025, with current cash earmarked for transaction-related premiums, fees and expenses.

The company expects to redeem all outstanding 2025 notes on or about Oct. 15, 2020, subject to the completion of the offering and the receipt of the proceeds, totaling an aggregate redemption price of nearly $970.8 million, plus a final interest payment.

Just last week, Hologic shares ticked up after news that the company boosted its financial outlook for the fourth quarter, improved from projections in its third-quarter results from July, coming on the back of reporting a strong third quarter boosted by COVID-19 test sales.

HOLX shares ha…

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CarThera collects $14.3M

CarThera announced today that it received a $2.3 million (€2 million) grant and $12 million (€10.5 million) in equity, totaling $14.3 million.

Paris-based CarThera was selected by the EIC Accelerator Pilot to receive the funds as it develops its Domeus project for treating glioblastoma patients. In addition to the money, CarThera is also slated to receive business coaching and mentoring through the accelerator, according to a news release.

The company’s Domeus project includes a multicenter, pilot clinical study for its SonoCloud-9 device designed to increase the intracerebral penetration of oncology drugs by transiently opening the blood-brain barrier without increasing dose or subsequent toxicity.

CarThera believes the project will lead to a scale-up in its processes and organizational structure and extend the functionalities of the SonoCloud device. Once completed, the project will transition the company’s status from a clinical-stage to a…

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Fitbit wins U.S., EU regulatory approval for ECG app

Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app.

San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release.

The Fitbit Sense wearable smartwatch is the company’s first device compatible with the ECG app, allowing users to hold their fingers to the stainless steel ring on the watch while holding still for 30 seconds to get a reading that can then be shared with a doctor.

With an on-wrist skin temperature sensor, an electrodermal activity sensor for managing stress and six or more days of batter life, the device is designed to help users control wellbeing on multiple fronts.

As part of its regulatory submission process, Fitbit conducted a multi-site clinical trial across the U.S. w…

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