coronavirus Archives - Page 68 of 99 - Medical Design Sourcing

Hologic says revenue nearly doubled in Q1

Hologic (NSDQ:HOLX) announced today that its revenues nearly doubled year-over-year in the first quarter of fiscal 2021.

Marlborough, Mass.-based Hologic expects to report revenues of more than approximately $1.6 billion, an increase of 89.3% from the first quarter of 2020. That tops the company’s November guidance of between $1.35 billion and $1.425 billion for the quarter ended Dec. 26, 2020, according to a news release.

“Hologic’s strong momentum continued in the first quarter of fiscal 2021 as organic revenue more than doubled, well ahead of our prior expectations,” Hologic chairman, president & CEO Steve MacMillan said in the release. “Thanks to the incredible efforts of our diagnostics team, we provided almost 30 million COVID-19 tests to global customers in the quarter. Importantly as well, our breast Health and surgical businesses showed remarkable strength, with each franchise posting growth in all major geographies – the United States, Europ…

EU OKs Moderna COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of European Medicines Agency (EMA), in a statement. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”

EMA has also authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) on Dec. 21. It has not, however, given the greenlight to the vaccine from Oxford University and AstraZeneca, which is now available in the U.…

NIAID-backed COVID-19 trial to investigate monoclonal antibodies from Brii Biosciences

Monoclonal antibodies could play a vital role in the battle against COVID-19. To date, such infusion-delivered antibodies from Eli Lilly (NYSE:LLY) and Regeneron Pharmaceuticals (NSDQ:REGN) have received emergency use authorization from FDA.

Now, a phase 2/3 clinical trial will study the potential of investigational monoclonal antibody therapy for patients with mild-to-moderate COVID-19.

The antibodies, known as BRII-196 and BRII-198, are licensed to Brii Biosciences, a Beijing-based company. Phase 1 trials for COVID-19 infections commenced in July 2020.

The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor the phase 2/3 trial as part of the ACTIV-2 master protocol, which is assessing the potential of several experimental therapies to treat mild-to-moderate COVID-19. The ACTIV-2 trial began in August 2020 with an investigation of another monoclonal antibody, LY-CoV555, from Lilly and AbCellera Biologics (NSDQ:ABCL).

Th…

Moderna and NIH assessing whether COVID-19 vaccine doses can be halved

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

AstraZeneca (LON:AZN) inadvertently discovered halving the first dose of its COVID-19 vaccine could boost its efficacy.

Researchers at the National Institutes of Health (NIH) and Moderna (NSDQ:MRNA) are examining vaccine data to determine whether they can halve the 100-microgram dose to vaccinate twice as many people.

Some data from Moderna’s clinical trial support that possibility, according to Moncef Slaoui, head of Operation Warp Speed.

“We know [a half dose] induces identical immune response” to the recommended dose in individuals aged 18 to 55, Slaoui said on CBS’ “Face the Nation.”

Slaoui’s comment referenced a Phase 2 clinical trial designed to test for an immune response rather than vaccine efficacy.

To date, about 4.8 million Americans have received COVID-19 vaccines. States have received an additional 13 million doses, according to the CDC.

The U.…

Akston Biosciences and LakePharma team up on second-generation COVID-19 vaccine

An inexpensive investigational vaccine known as AKS-452 is stable for weeks at room temperature and can potentially be used for both prime and boost vaccination.

The vaccine developer, Akston Biosciences (Beverly, Mass.), has hooked up with LakePharma, a San Carlos, Calif.-based contract research, development and manufacturing outsourcing organization, to manufacture the vaccine. Phase 1/2 clinical trials for the vaccine will begin later this month at the University Medical Center Groningen in the Netherlands.

The vaccine candidate, pictured on the left, has shown promise in preclinical animal studies where it is initiated robust antibody production at microgram doses.

The AKS-452 can be produced using conventional antibody manufacturing techniques.

The developer describes the vaccine as “the most advanced” investigational COVID-19-specific Fc fusion protein vaccine.

FDA authorized more than 300 COVID-19 tests and collection kits in 2020

(Image from Mayo Clinic)

The FDA says it authorized more than 300 COVID-19 test and collection kits in 2020.

COVID-19 first made waves at the end of 2019 but began to spread throughout the U.S. in the early months of 2020. As the country faced a pandemic, a number of companies developed diagnostics in an effort to slow the spread, with the FDA beginning to issue emergency use authorization (EUA) for the tests in March.

The more than 300 tests and collection kits included 235 molecular diagnostics, 63 antibody tests and 11 antigen tests as of Dec. 28, 2020.

Included in the range of tests are 38 at-home collection kits with samples sent to labs, 18 pooling (processing samples from multiple people at once) tests, 17 point-of-care/rapid tests, 11 multi-analyte (detecting SARS-CoV-2 and other viruses like the flu) and three at-home tests with a self-collected sample.

“Our Center for Devices and Radiological Health (CDRH) has made enormous contrib…

FDA warns on false negatives with Curative COVID-19 test

The FDA yesterday alerted healthcare providers and patients that there is a risk of false results with the Curative SARS-CoV-2 test.

The Curative SARS-CoV-2 assay is authorized for prescription-only use as a real-time RT-PCR test used to detect the virus causing COVID-19. The test analyzes throat swabs, nasopharyngeal swabs, nasal swabs and/or oral fluid specimens from an individual suspected of having COVID-19 by their healthcare provider, according to an FDA release.

Under the FDA emergency use authorization (EUA), the specimen collected for the Curative SARS-CoV-2 assay is to be processed at the KorvaLabs laboratory before results are returned to the patient.

According to the FDA, the risk of false results, particularly false-negative results, could lead to delayed treatment or an overall lack of treatment, as well as a lack of monitoring for infected individuals and their household or other close contacts, resulting in a risk of further spreading of …

Pfizer and BioNTech to offer COVID-19 vaccine to placebo recipients

[Photo by Daniel Schludi on Unsplash]

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have decided to offer to inform clinical trial volunteers in its COVID-19 vaccine whether they received a vaccine or placebo. Those who received a placebo will be eligible to receive the first dose of vaccine by March 1 and stay in the study. A second dose will be administered roughly three weeks after the first dose.

Roughly half of the 44,000-plus participants in the BNT162b2 vaccine trial received a placebo.

The question of whether to vaccinate placebo recipients in COVID-19 vaccine studies is difficult to answer. “We face this in every clinical trial, particularly on data monitoring committees,” said Dr. Steven Goodman, professor of epidemiology at Stanford University, in an FDA advisory meeting for the Pfizer-BioNTech vaccine on Dec. 10. “There is tension between actions that are good for an individual, which in the…

MedTech 100 roundup: Ringing in the New Year with another high

For the third time in the past four weeks, stocks within the medtech industry climbed to never-before-seen heights as 2021 reared its head.

Previous highs have largely been a result of the FDA granting Moderna emergency use authorization for its vaccine candidate and its subsequent rollout to the U.S., joining the one made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), which began to be administered last month.

With the industry plugging along, MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 104.67 (Jan. 1), marking its highest-ever total and a 1% uptick from the 103.63 points registered at the end of the week prior (Dec. 25, 2020).

A slight downturn came after the index hit a new high (100.75) on Dec. 4, 2020, beating the mark of 100.65 set on Nov. 9 and setting a new all-time high since the index started being recorded on Jan. 1, 2001. However, stocks have continued to rise …

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…

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…

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 …