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With RNA being the popular new “it” molecule in genetic research, Ayesha discusses Eli Lilly’s new partnership with biotech company ProQR to develop RNA-based therapeutics in this episode. The $1.5 billion deal will see Lilly leverage ProQR’s proprietary RNA editing platform to develop targets of interest. The team discusses how the success of the mRNA COVID-19 vaccines have heightened interest in RNA-based therapies.
The editorial team also talked about a new study that found walking 7,000 steps leads to a decreased risk of premature death among middle-aged adults by 50 to 70 percent. It turns out that the popularized “10,000 steps-a-day for good health” notion is no more than a mere myth as it is not an evidence-based recommendation. The new study provides a basis for the establishment of scientifically-backed guidelines for physical activities like walking.
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Eli Lilly Pursues RNA Editing in New Partnership with ProQR
How Many Steps a Day Should You Actually Be Taking? New Study Shows Less May Be More
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Knee replacements may soon be getting smarter with the world’s first smart knee implant. In this episode, Ayesha discusses a new personalized knee implant with integrated smart technology that recently received FDA clearance. Using sensors and cloud connectivity, it can help patients and practitioners monitor post-operative progress in real-time.
The editorial team also talked about new data from a clinical validation study for an Alzheimer’s blood test that can predict the disease years before symptoms appear. The team discussed how useful this would actually be from a patient perspective, as there is no cure for Alzheimer’s and treatments are limited.
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How the World’s First “Smart” Knee Implant Aims to Change Knee Replacement Recovery
New Study Shows Diadem’s AlzoSure Alzheimer’s Blood Test Can Predict Disease Years Before Diagnosis
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If 20 percent of the 250 million antibiotic prescriptions written globally each year are unnecessary, are there more drug-resistant superbugs in our future? In this episode, Sarah talks about the importance of paying attention to antimicrobial resistance (AMR) and how surveillance programs will be key to preventing the next pandemic.
The team debates when it’s appropriate to treat patients with antibiotics and discusses how bacterial infections are identified. They also talk about the link between serious SARS-CoV-2 infections and secondary bacterial infections and how the current COVID-19 pandemic has highlighted the importance of addressing AMR as a global threat to public health.
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Why Antimicrobial Resistance is a Silent Pandemic
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In this episode, Sarah presents three ways that Alzheimer’s trials will change now that Biogen’s Aduhelm (aducanumab) has been approved by the FDA. The team discusses whether placebo-controlled trials are still ethical and how ongoing dementia studies can manage patient attrition. Can trials pivot to allow patients to aducanumab as a background therapy?
The hosts also discuss how the price of aducanumab may limit patient access, and what it might take for payers to cover the cost of this pricey drug.
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AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials
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In this episode, Ayesha discussed the US Food and Drug Administration’s (FDA) authorization of a third dose of the Pfizer and Moderna COVID-19 vaccines for immunocompromised individuals. These individuals would primarily include organ transplant recipients, as well as patients taking immunosuppressive drugs for conditions like cancer and HIV/AIDS. Many people with weakened immune systems have been shown to have either low antibody titers, or none at all, after receiving a standard two-dose regimen of the Pfizer and Moderna COVID-19 vaccines. The FDA said additional vaccine doses for the general public are currently unwarranted. The editorial team discussed whether COVID-19 vaccine boosters could become a norm depending on how the SARS-CoV-2 virus, and the pandemic it has caused, evolves.
FDA Authorizes COVID-19 Vaccine Boosters for Immunocompromised Individuals
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In this episode, Ayesha discussed a presentation at this year’s Alzheimer’s Association International Conference (AAIC) 2021 about the impacts of COVID-19 on cognitive health. The study, conducted at New York University Langone Health, found that in cognitively normal COVID-19 patients that experienced the neurological symptom of confusion due to toxic-metabolic encephalopathy (TME), levels of serum biomarkers associated with neuroinflammation, neuronal injury and Alzheimer’s disease (such as phosphorylated Tau 181 and neurofilament light protein) were higher than in patients that did not have TME. The strong correlation of these serum biomarkers with the presence of neurological symptoms in COVID-19 patients suggest that COVID-19 patients could experience an acceleration of AD/ADRD symptoms and pathology.
Ayesha also discussed another story about serum biomarkers for the early detection of pancreatic cancer. Immunovia, a Swedish biotech firm, has developed a nine-panel biomarker blood test that can be used for the detection of pancreatic in early stages. The company’s American subsidiary, located in Massachusetts, received approval for the test early this month and the Massachusetts Department of Public Health has already begun using it to test patients for the deadly cancer. The test evaluates a combination of immunoregulatory and tumor biomarkers. Early detection of pancreatic cancer is a significant unmet clinical need because the cancer is typically diagnosed in late stages when treatment options are limited and the disease is difficult to treat.
AAIC 2021: Insights into COVID-19 Impacts on Cognitive Health
Immunovia’s Pancreatic Cancer Blood Test is World’s First for Early Disease Detection
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In this episode, Sarah talked about attending the Alzheimer’s Association International Conference (AAIC) 2021 virtually this year and discussed increasing diversity in Alzheimer’s clinical trials as an important topic that was part of the conference. Black and Hispanic people are more likely to be diagnosed with Alzheimer’s compared to Caucasians. Sarah outlined the results of some studies shared at the meeting, including a study that revealed people of minority backgrounds would be more likely to participate in a trial if they were directly invited to participate by someone of their own race, and if a family member had the disease. Exclusion criteria could also inadvertently exclude potential participants based on race, warranting the need for trial designs that foster greater inclusivity, including outreach tools, to broaden recruitment.
Related to the theme of racial inequities in healthcare as well as the health and beauty industry, Ayesha discussed a recent lawsuit launched against Johnson & Johnson over its iconic baby powder by a Black women’s advocacy group. The group claims that the company engaged in targeted marketing of their baby powder to Black and Hispanic women, whilst knowing for decades about asbestos impurities in their product; the company has been facing thousands of individual lawsuits over the years over links to use of the baby powder and ovarian cancer and mesothelioma. As part of the lawsuit, the advocacy group is calling on Johnson & Johnson to rectify its past ad campaigns by creating new adverts that are equitable and have “corrective marketing” that warn Black women of the risks associated with the product.
Read the full articles here:
Diversity in Clinical Trials: Tackling the Issues in Alzheimer’s Research at AAIC 2021
Black Women’s Group Launches Lawsuit Against Johnson & Johnson Over Targeted Baby Powder Ads
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In this episode, Ayesha discusses a set of recommendations for use of the new FDA-approved Alzheimer’s treatment Aduhelm (aducanumab) published by an expert panel, which was shared at the Alzheimer’s Association International Conference (AAIC) 2021 this week. Ayesha and the team talked about the controversial approval of the drug, with lingering questions about its clinical benefit despite having the ability to reduce amyloid plaques as an anti-amyloid monoclonal antibody. It appears that clinicians and scientists in the field have embraced the treatment for the most part and are working towards developing clear guidelines and an infrastructure for the drug’s use in the goal of helping patients that could most benefit from the treatment.
The team also talked about Pfizer’s expanded recall of its smoking cessation drug Chantix, which now involves 12 lots. The recall is over the finding of higher than acceptable levels of a potentially carcinogenic nitrosamine in the batches of Chantix tablets produced between 2019 and 2021. Pfizer and the FDA maintain that the benefit of the medication outweighs the risks and that patients should continue using the drug, which is intended for short-term use. Long-term exposure to high amounts of nitrosamines has been linked to cancer-causing effects. The team talked about the increasing findings of impurities in drug manufacturing leading to similar recalls for other drugs recently, and how pharmacists and care providers should be more informed about them to help patients navigate the recalls.
Read the full articles here:
AAIC 2021 Coverage: Expert Panel Unveils Recommendations for Biogen’s Aduhelm
Chantix Recall: Pfizer Expands Withdrawal of Smoking Cessation Drug Over Carcinogen Concerns
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In this episode, Ayesha talks about the misleading headlines that ensued after WHO chief scientist Dr. Soumya Swaminathan made comments in a press briefing about mixing and matching COVID-19 vaccines and how there is currently no data to support additional doses and boosters at this time. News agencies like Reuters were at the helm of the misleading headlines, which took the comments out of context, stating that mixing and matching vaccines was outright dangerous. The team discussed the responsibility of media outlets to report information objectively and without sensationalist, clickbait headlines, and how the WHO can do a better job with its messaging.
The team also learned about a new, first-of-its-kind saliva test for measuring glucose levels in diabetic patients. The test was developed by researchers at the University of Newcastle in Australia and involves a strip with a glucose biosensor. Users simply lick the strip and insert it into a glucose monitor. The needle-free, non-invasive test is a welcome alternative to being pricked with a lancet everyday for testing, helping make the injection experience pain-free and far less anxiety-inducing.
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Researchers Develop World’s First Saliva Test for Diabetes
Misleading Headlines Lead to Confusion Over WHO Comments on Boosters and Mixing and Matching COVID-19 Vaccines
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In this episode, Ayesha talks about Nestlé’s marketing of Seres Therapeutics’ oral microbiome drug for recurrent C. Difficile infection (CDI). CDIs are the leading cause of hospital-acquired infections in the US, with recurrence being a common problem. It typically develops after the use of antibiotics which can wipe out the gut’s healthy bacteria. Seres’ microbiome drug SER-109 aims to restore the healthy bacteria via an oral capsule that contains a protective species of gut bacteria. Nestlé has been a big player in the gastrointestinal space and first partnered with Seres in 2016. The latest venture of the partnership will have the food and beverage giant utilize its global pharmaceutical business Aimmune Therapeutics to take on the role of lead commercialization party for the oral microbiome drug.
The team also discussed the World Health Organization’s (WHO) adding IL-6 receptor blockers to its treatment guidelines for severely and critically ill COVID-19 patients. This includes IL-6 blockers from Roche (Actemra) and Sanofi (Kevzara). While IL-6 receptor antagonists initially met with mixed results in COVID-19 trials, recent data suggests it can cut improve survival outcomes in critically ill patients. The WHO also called on manufacturers to reduce the cost of the IL-6 receptor monoclonal antibodies to help increase access to the drugs in low- and middle-income countries.
Read the full articles here:
Nestlé to Market Seres’ Oral Microbiome Drug for C. Difficilev
WHO Calls on Roche and Sanofi to Lower Costs for Life-Saving COVID-19 Treatment
For more life science and medical device content, visit the Xtalks Vitals homepage.
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