In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.
Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.
Get the full story at our sister site, Medical Design & Outsourcing.
Dexcom VP of Global Clinical Initiatives Tomas Walker [Photo courtesy of Dexcom]
New data is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure.In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said.
Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach to chronic COVID-19 conditions, technology that can help diagnose new cases, and the likelihood that particular devices and components will be in greater demand in the years ahead.
The following has been lightly edited for space and clarity.
MDO: How does the SARS-CoV-2 virus and its COVID-19 disease affect the pancreas?
Walker: In February, March of 2020, there were a couple of papers published out of China very early in the expe…
[Image courtesy of Chad Davis via Flickr]
Where would clinical trial diversity be without the COVID-19 pandemic and the death of George Floyd on May 25, 2020? It likely wouldn’t be the priority it is today across the industry, according to Ariel Katz, CEO and co-founder of H1, a New York–based healthcare and data analytics platform firm.After the death of George Floyd, scores of pharma companies created or beefed up departments related to diversity and inclusion. “Basically, every pharma company and biotech is now doing something around diversity and inclusion and social determinants of health,” Katz said.
On Google, interest in the search phrase ‘clinical trial diversity’ surged from July 2020 to July 2021. Interest in the phrase continues to remain strong but has dipped from its peak.
Things have changed considerably during the pandemic.
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GSK plc (LSE/NYSE:GSK) and Sanofi (NYSE:GSK) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study.
For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron.
The vaccine is based on the original D614 virus and the beta (B.1.351) strain.
Across variants, the vaccine was 64.7% efficacious against symptomatic infection in adults. For those previously infected with COVID-19, the vaccine was 75.1% efficacious overall.
GSK and Sanofi noted that the vaccine candidate appeared to be well-tolerated.
Moderna (Nasdaq:MRNA) is developing a bivalent omicron booster vaccine candidate known as mRNA-1273.214.
Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) have released minimal data to date on their next-generation COVID-19 vaccine.
Sanofi’s and GSK’s Phase 3 COVID-19 clinical trial, dubbed VAT08, enrolled more …
After struggling to find support for its inactivated whole-virus COVID-19 vaccine candidate VLA2001, French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has received a €90.5 ($95) million investment from Pfizer (NYSE:PFE), which amounts to 8.1% of the company’s share capital at a price of €9.49 per share.
The Saint-Herblain, France–based company plans on using the funding to support a planned Phase 3 study involving the Lyme disease vaccine candidate VLA15. Pfizer will lead the Phase 3 study, scheduling it for the third quarter of 2022.
In February, Valneva and Pfizer announced positive data from a Phase 2 study of the VLA15 vaccine. The data suggested that a three-dose primary series of the vaccine promised to offer a robust immune response.
In related news, the European Medicines Agency recently recommended authorizing Valneva’s VLA2001 COVID-19 vaccine for individuals between 18 and 50.
After the vaccine won regulatory approval …
The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.
The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.
SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22 COVID-19 patients with multiple organ failure in ICUs. The treatment reduced mortality to 50% (compared to 81% in the control group), while patients who used the device for more than 96 hours saw…
SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.
The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.
SeaStar Medical CEO Eric Schlorff [Photo courtesy of SeaStar Medical]
SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22…Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months to 4 years old can now be vaccinated in the U.S.
FDA authorized the shots for young children on June 17, while CDC did so a day later.
“The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old,” said President Joe Biden in a press briefing. “And for the first time in our fight against this pandemic, nearly every American can now have access to life-saving vaccines.”
Biden noted that the U.S. government had ample supplies of vaccines for young children and had coordinated with states, local health centers, pharmacies and pediatricians to help administer the shots.
“My administration, with the help of the CDC, has been planning and preparing for this moment for a long time,” Biden said.
The federal government has also created a webs…
Until recently, the Pfizer-BioNTech COVID-19 vaccine was available for all individuals 5 years of age and older, while the Moderna vaccine was authorized for individuals at least 18.
Now, the FDA has authorized the use of both vaccines in children from 6 months to four years old. In addition, the agency also agreed to allow the use of the Moderna vaccine in children aged 5 to 17.
“We know that many parents, caregivers and clinicians have been anxiously awaiting today’s authorizations,” said FDA Commissioner Dr. Robert M. Califf in a press briefing. “We’re acutely aware of the importance of having vaccines available for our youngest children. And as we’ve seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19 such as hospitalization and death.”
Califf went on to stress that robust data support the use of safety and effective…
The most popular COVID-19 antiviral is Paxlovid (nirmatrelvir [PF-07321332] and ritonavir). The manufacturer of the drug, Pfizer Inc. (NYSE: PFE), anticipates selling about $22 billion worth of Paxlovid this year.
Complicating matters, however, is the failure of the drug to meet its primary endpoint of self-reported, sustained alleviation of all COVID-19 symptoms for four consecutive days in the EPIC-SR study.
In a press release describing the gathering of new data to support a new drug application submission, Pfizer noted that EPIC-SR data from standard-risk vaccinated and unvaccinated patients were not statistically significant but underscored its efficacy overall.
In the EPIC-SR study, the drug passed the statistically significant threshold of reducing COVID-19-related medical visits per day compared to placebo by 62%. In addition, the study found a non-significant 70% relative risk reduction for the key secondary endpoint of hospitalization or death.…
While vaccines have emerged as a central tool in battling the COVID-19 pandemic, the SARS-CoV-2 virus continues to fuel waves of infections.
COVID-19 antivirals could play a vital role in managing the disease in the future, and a handful are currently in use in the U.S.
One possible way to accelerate the development of additional antivirals for COVID-19 and other respiratory viral infections is the availability of more accurate preclinical models.
The nonprofit engineering innovation company Draper has released a study showing the power of combining human tissue models based on an organ-on-chip platform in a dynamic tissue microenvironment with input from microbiologists and bioengineers.
In essence, the Cambridge, Massachusetts–based company has developed a human lung model known as PREDICT96-ALI that can gauge the efficacy of SARS-CoV-2 drugs, including antivirals.
In the research published on the pre-print server bioRxiv, researcher…
Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines.
The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15 days after vaccination. The same vaccine also yielded a 15-fold increase against the original D614 virus and a 30-fold increase against the beta strain.
The results were from two studies, the VAT02 Cohort 2 and COVIBOOST VAT013.
The new vaccine candidate elicited a more robust immune response than the Pfizer-BioNTech booster vaccine or the first-generation Sanofi-GSK vaccine candidate.
Last week, Moderna (Nasdaq:MRNA) also announced that its bivalent omicron booster vaccine candidate, mRNA-1273.214 yielded 1.75 times more neutralizing antibodies t…