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COVID-19 lab-leak theory re-emerges as U.S. intelligence report surfaces

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]

A previously undisclosed U.S. intelligence report revealed that three scientists from China’s Wuhan Institute of Virology became sick enough in November 2019 to seek hospital care, according to the Wall Street Journal.

The illnesses were consistent with both COVID-19 and common seasonal illnesses, but the report fuels speculation that the scientists at the Wuhan lab were among the first to contract the SARS-CoV-2 virus.

The disclosures have heightened calls for an independent probe into the origin of the pandemic because the Wuhan Institute of Virology has researched coronaviruses. The time frame of the workers’ hospital visits coincided with the beginni…

MedTech 100 roundup: Turnaround for the industry?

A turgid month for the medtech industry might be drifting into the past after the past week indicated a slight turnaround as summer nears.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week at 107.74 points, marking a 1.4% rise from the 106.22-point mark set one week prior.

Having endured its largest slide of 2021 in recent weeks, the index is already demonstrating signs of a rebound after April brought the industry’s all-time best performance.

Despite the setbacks that have plagued the industry over the past month or so, medtech’s performance continues to reflect a rebound from the struggles brought on by the COVID-19 pandemic. Overall, it has registered a 16.7% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 73.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall markets were on the opposite end of the spectrum over the p…

Eurofins gains EUA for young children’s COVID test

Eurofins announced today that it received FDA emergency use authorization (EUA) for its at-home COVID-19 testing kit for children three years of age and older.

Luxembourg-based Eurofins’ Clinical Enterprise subsidiary became the first to receive EUA for an at-home nasal PCR test for young children with the empowerDX kit, according to a news release. In March, Eurofins launched the direct-to-consumer, FDA-authorized at-home COVID-19 test kit for consumers 18 years of age and older.

The test kit is available through Eurofins’ Clinical Enterprise/empowerDX subsidiary and can be ordered online for $99, while kits are also available for purchase on Amazon, at RiteAid and through Uber’s on-demand delivery service.

Eurofins’ kit includes step-by-step instructions for the user, a shallow nasal swab, a test tube and a pre-paid FedEx package for the simple return of samples, for which customers will receive results through a secure patient …

COVID-19 vaccine adverse events: Separating the signal from the noise

Image by Spencer Davis from Pixabay

In the U.S., more than 125 million people have been fully vaccinated against COVID-19. While most vaccine recipients tend to have relatively minor and fleeting adverse events from the shots, many people continue to worry about side effects.

According to a recent survey from the physician social network Sermo found that 72% of physicians reported that their patients continue to be concerned about vaccine side effects. Almost 30% of physicians surveyed have encountered patients who have skipped their second dose over adverse event concerns.

Scientific rigor and solid epidemiology are needed to improve our understanding of vaccine safety, according to Dr. Jan Bonhoeffer, a Switzerland-based expert on infectious diseases and vaccine safety who is the founder of the non-profit foundation Heart Based Medicine.

“We need to formulate the right questions to provide th…

BD to build $200M facility in Spain for pre-filled drug delivery device manufacturing

BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain.

The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release.

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

BD to build $200M facility in Spain for pre-filled drug delivery device manufacturing

BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain.

The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release.

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

Cue Health raises $235M to support its over-the-counter, home-use diagnostics

Healthcare technology company Cue Health announced that it closed a private financing round worth $235 million.

Existing investors Johnson & Johnson Innovation — JJDC, Decheng Capital, CAVU Ventures, ACME Capital and more contributed to the financing, as did new investors Perceptive Advisors, MSD Capital and Koch Strategic Platforms, according to a news release. Morgan Stanley served as exclusive financial advisor to Cue for this transaction.

San Diego-based Cue Health said it earmarked the capital raised to accelerate its growth as it develops digital health technologies, starting with diagnostics. In October 2020, the company received a $481 million government contract for its point-of-care COVID-19 diagnostic.

Cue develops the Cue Health Monitoring System, which it designed to deliver a wide range of tests through one system. Its current uses include COVID-19 testing in enterprises, schools, nursing homes, hospitals and more.

The company ad…

CureVac and GSK announce promising preclinical data for next-gen COVID-19 vaccine

As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK.

In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination.

Tübingen, Germany–based CureVac also said the vaccine candidate led to high levels of antibodies against several variants of concern, including B.1.1.298, B.1.1.7 and B.1.351.

“To successfully fight the COVID-19 pandemic in the long term, we will need different vaccines, and we need to be able to respond effectively to emerging variants,” GSK Global Vaccines President Roger Connor said in a statement.

CV2CoV uses a new mRNA platform than CureVac’s first COVID-19 vaccine candidate known as CVnCoV. The new platform intends to bolster intracellular mRNA stability and translation to y…

United, Abbott partner to use rapid COVID-19 test for international travel

Abbott’s BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]United Airlines and Abbott announced a collaboration to use the latter’s BinaxNOW COVID-19 home test to make international travel more seamless.

Recent CDC guidelines permit travelers to self-administer a rapid antigen test under the real-time supervision of a telehealth service and use the verified negative result to board an international flight to the U.S., according to a news release.

The collaboration will combine Abbott’s BinaxNOW COVID-19 test and the NAVICA app to provide testing and make international travel to the U.S. safer and easier for travelers amid the ongoing pandemic.

“We appreciate the private sector proactively helping travelers have access to easy, reliable COVID-19 test options,” CDC Director Dr. Rochelle P. Walensky said in the release. “Comprehensive testing that is easy, rapid, accurate and trusted is a fundamental strategy for preventin…

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

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

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” wrote Acting FDA Commissioner Janet Woodcock, MD, in prepared remarks. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

An advisory committee of the Centers for Disease Control and Pr…

MedTech 100 roundup: Largest slide for industry in 2021

The medtech industry’s 2021 performance has been all over the place and the past weekend highlighted its topsy-turvy nature.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been on the rise since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week.

After a -1.6% decrease over the week ending on April 30, there was little indication of in which direction the index would head next. The industry’s response to the slight dip was an even sharper downturn with a 4.49-point loss.

On May 6, the index finished the day at 108.21, representing a -4% slide from the previous week’s mark and a -5.6% fall from the high-point set the previous week. Th…