Thermo Fisher to manufacture Inovio COVID-19 vaccine candidate

Inovio Pharmaceuticals (NSDQ:INO) announced that Thermo Fisher Scientific (NYSE:TMO) will manufacture its COVID-19 vaccine candidate.

Plymouth Meeting, Pa.-based Inovio said in a news release yesterday that Thermo Fisher signed a letter of intent to manufacture the INO-4800 COVID-19 vaccine candidate, joining a consortium of third-party manufacturers that aim to produce 100 million doses of Inovio’s vaccine by 2021, subject to FDA approval.

Get the full story at our sister site, Drug Delivery Business News.

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Pfizer touts animal 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.

Get the full story at our sister site, Drug Discovery & Development.

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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.

Get the full story at our sister site, Drug Discovery & Development.

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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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How the presidential election could affect medtech

No matter who ends up in the White House, there will need to be a reckoning over how the government’s relationship with medtech has changed, according to industry insiders.

(Image by Markus Winkler on Unsplash)

It’s been a tumultuous few years for the medical device industry, with highs and lows that no one could have foreseen.

President Donald Trump’s administration streamlined some FDA processes. The medical device excise tax, enacted during the Obama-Biden administration, was permanently repealed.

But any normal state of affairs in the industry was upended by the coronavirus pandemic. COVID-19 disrupted supply chains, brought elective surgeries to a halt and attracted all sorts of businesses to jump into an industry that they knew nothing about. The pandemic also brought about unprecedented cooperation within medtech and betw…

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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.

Get the full story at our sister site, MassDevice.
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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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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.

“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the pledge states. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly dem…

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MedTech 100 roundup: Stocks top pre-pandemic high

After weeks of flirting with the heights hit before COVID-19 ravaged the markets, medtech stocks finally topped the pre-pandemic high last week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — spiked up to 93.11 points on Sep. 2, nearly a full point ahead of the pre-pandemic high of 92.32, which the market reached on Feb. 19.

Medtech stocks had hit a previous mid-pandemic high of 91 points last week, hanging around there before the sudden rise to 93.11, which was followed by a quick dip to 90.64 points 24 hours later.

The index dipped from that peak, though, sitting at 89.29 points at the end of last week (Sep. 4). Overall, medtech stocks saw a -1.6% decrease from the 90.78-point total at the same time a week prior (Aug. 28).

The most recent high mark represents a 0.9% rise from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -3.3% decrease from that pre-pande…

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How decontamination could solve the COVID-19 mask shortage problem

With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks.

(Image courtesy of Brian McGowan on Unsplash)

A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks.

Hundreds of frontline healthcare workers have died from the virus since the pandemic struck in China in 2019, bringing the need for effective face masks into sharp relief. But despite the efforts of 3M and other companies worldwide to boost production of the most effective filtering masks — N95s — there still might not be enough.

Get the full story on our sister site, Medical Design & Outsourcing.

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Roche test for both COVID-19 and influenza receives EUA

Roche (SWX: RO,  ROG) announced today that the FDA has granted an EUA for its Cobas SARS-CoV-2 and Influenza A/B Test for use on Cobas 6800 and 8800 systems.

The test is also available in nations accepting the European Union’s CE Mark.

The new Roche test can provide simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in people.

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” Roche Diagnostics CEO Thomas Schinecker said in a news release.

 

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