Xtalks Life Science Podcast

How the Approval of Aducanumab Will Change Alzheimer’s Trials

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. Read the full article here: AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical TrialsFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

FDA Authorizes COVID-19 Vaccine Boosters for Immunocompromised Individuals

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 IndividualsFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

AAIC 2021 – COVID-19 Impacts on Cognitive Health + Pancreatic Cancer Blood Test

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 HealthImmunovia’s Pancreatic Cancer Blood Test is World’s First for Early Disease DetectionFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

AAIC 2021 - Diversity in Clinical Trials + Johnson & Johnson Sued by Black Women’s Group

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 2021Black Women’s Group Launches Lawsuit Against Johnson & Johnson Over Targeted Baby Powder AdsFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

AAIC 2021 – Aduhelm Recommendations + Pfizer’s Expanded Chantix Recall

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 AduhelmChantix Recall: Pfizer Expands Withdrawal of Smoking Cessation Drug Over Carcinogen ConcernsFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

WHO Comments on COVID-19 Vaccine Mixing + World’s First Glucose Saliva Test

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. Read the full articles here: Researchers Develop World’s First Saliva Test for DiabetesMisleading Headlines Lead to Confusion Over WHO Comments on Boosters and Mixing and Matching COVID-19 VaccinesFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

Nestlé to Market Oral Microbiome Drug for C. Difficile + WHO Recommends IL-6 Blockers as Life-Saving COVID-19 Treatment

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.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

First FDA-Approved Video Game for ADHD + Why Not to Worry About Menstrual Changes After COVID-19 Vaccination

In this episode, Ayesha talks about the launch of a digital marketing campaign for the first FDA-approved therapeutic video game to help treat ADHD. The video game, called EndeavorRx, is installed as an app on smart phones and tablets. It was developed by digital medicine company Akili Interactive. The game is available by prescription and is indicated for children eight to 12 years of age with primarily inattentive or combined-type ADHD who have a demonstrated attention issue. Akili launched the first ad campaign for the game on Instagram and is also looking to advertise on other social media outlets. While the game is to be used alongside traditional ADHD medications, it could lower medication doses and serve as a promising non-pharmaceutical alternative for ADHD treatment in children.The team also discussed growing reports of how some women have been experiencing changes in their menstrual cycle following COVID-19 vaccination. While the link between the vaccines and irregular periods have not been studied, experts say the changes are short-term and are not of concern. In fact, vaccination against influenza and HPV are known to lead to temporary menstrual changes. The COVID-19 vaccines may trigger similar changes due to activation of immune cells in the uterus or inflammation, or just simply due to stress around getting vaccinated. Until a causal link is shown, the group agreed that people should not be taken in by conspiracy theories about menstrual cycle changes as related to fertility and pregnancy; the vaccines have been shown to have no effect on the latter. Read the full articles here: Akili Launches Digital Ad Campaign for First FDA-Approved ADHD Video GameWhy the Potential Effects of COVID-19 Vaccines on the Menstrual Cycle Are Not ConcerningFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

NeuraLace’s Peripheral Nerve Stimulation System for Chronic Pain + AstraZeneca Fights COVID Vaccine Delivery Lawsuit

In this episode, Ayesha talks about a peripheral nerve stimulation system for chronic pain developed by biotech company NeuraLace that received 510(k) FDA clearance last week. The device uses electromagnetic induction technology to directly target nerves damaged from injuries like accidents, surgery and burns among others. The goal is to stimulate damaged nerves involved in the body’s natural pain-relief pathways, helping alleviate pain at the source rather than trying to mask it as most other neuromodulatory and pharmacological methods do. The device received FDA 510(k) clearance, allowing for marketing of the system before its final approval.The team also discussed AstraZeneca’s legal troubles and how it won in the latest hearing of a lawsuit launched by the European Commission over failure to deliver on the promised number of doses of its COVID-19 vaccine to the EU. The Commission filed the lawsuit against the drugmaker in April over not only failing to meet promised vaccine targets, but also over not making use of all its manufacturing plants as outlined in the contract. A Brussels court found that it does not have exclusivity or right of priority over contracting parties, and also dismissed other measures being sought by the Commission. The group talked about how almost every company with a COVID-19 vaccine has had manufacturing delays and difficulties in meeting global demands in this unprecedented crisis.Read the full articles here: NeuraLace’s Peripheral Nerve Stimulation System Wins FDA Clearance for Chronic Pain AstraZeneca Prevails in EU COVID-19 Vaccine Lawsuit For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

Measuring Body Fat Percentage with Amazon’s Halo app + Regeneron’s Antibody Treatment Cuts Risk of COVID-19 Deaths

In this episode, Ayesha discusses the results of a recent study that show Amazon’s Halo app can accurately estimate body fat percentage with results comparable to traditional DXA testing. The app has built-in AI algorithms that analyze images taken from a user’s smartphone, which are used to build a 3D model of the body and generate an estimate of body fat percentage within seconds. The app is easy to use and offers users the convenience of assessing their body fat composition from the comfort of their homes, instead of having to go to a clinic and wait for several days or weeks for results. The team also talked about Regeneron’s monoclonal antibody treatment for COVID-19 that has been shown to reduce the risk of deaths by 20 percent among hospitalized COVID-19 patients in results from the UK RECOVERY trial. The treatment consists of two monoclonal antibodies that target the spike protein of SARS-CoV-2. The team discussed how it is still important to research effective treatments for COVID-19 despite having vaccines because of circulating variants, and the potential for new ones, as well as continuing high case numbers in some countries. Moreover, continuing to develop new technologies and treatments will be beneficial for other current and future infectious diseases.Read the full articles here:Study Shows Amazon’s AI-Powered Halo App Can Accurately Assess Body Fat PercentageRegeneron’s COVID-19 Monoclonal Antibody Treatment First to Reduce Risk of Death in Hospitalized PatientsFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured