Xtalks Life Science Podcast

Researchers Develop Arthritis Vaccine + Medtronic Expands Recall on Insulin Pumps

In this episode, Ayesha talks about World Arthritis Day, which is on October 12 every year, with this year’s theme being raising awareness about early diagnosis. In addition to timely diagnosis, there may soon be a preventative vaccine for inflammatory arthritic conditions such as rheumatoid arthritis. Researchers at the University of Toledo have developed a vaccine against inflammatory arthritis that has shown promise in animal models. The team talked about how a vaccine for arthritis is a somewhat novel and exciting concept and whether such a vaccine would be universally available, or only administered to certain demographics based on age and other risk factors for the disease. The editorial team also discussed Medtronic’s expanded recalls of the remote controllers for certain models of its MiniMed insulin pumps over cybersecurity concerns, as well as its 600 series insulin pumps due to a faulty retainer ring. The recalls affect almost half a million devices combined. The potential cybersecurity risk associated with the remote controllers could under- or over-deliver insulin to patients if an unauthorized user hacks into the system. The team discussed how there should be better contact methods and potentially centralized systems for drug and medical device recalls as many consumers may be left unaware that they have an affected product.Read the full articles here: How Researchers Stumbled Upon an Arthritis Vaccine Just in Time for World Arthritis DayMedtronic Expands Two Insulin Pump Recalls, Including One Over Cybersecurity 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

CDC Says Flu and COVID-19 Shots Can Be Co-Administered + Merck’s Oral Antiviral for COVID-19 Shows Stellar Results

In this episode, Ayesha talks about the CDC’s updated guidance according to which the COVID-19 vaccines can be administered at the same time as the flu shot and other vaccines. The new guidelines comes after the federal health agency says there is now substantial data around the COVID-19 vaccines to show that it is safe to be administered alongside other vaccines. Additionally, studies show that immunization against influenza may protect against severe symptoms of COVID-19.The editorial team also discussed the stellar trial results of Merck’s oral antiviral COVID-19 treatment molnupiravir. Last week Merck released interim data from a Phase III trial of the drug, which showed that it can cut the risk of hospitalizations and deaths by 50 percent. The results were so strong that the independent committee monitoring the trial suggested that the trial could be stopped. The team discussed the convenience of an oral pill treatment for COVID-19, and and how certain factions of the public appear to be less hesitant over COVID-19 treatments compared to COVID-19 vaccines.   Read the full articles here: CDC Says You Can Get Flu and COVID-19 Shots at the Same Time Merck’s Oral Pill Molnupiravir Cuts Risk of Hospitalizations and Deaths by Half in COVID-19 Patients 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

New FDA ”Bad Ad” Quiz + Pfizer COVID-19 Vaccine Data for Young Children

In this episode, Ayesha talks about the FDA’s new interactive quiz as part of its Bad Ad outreach program that targets misleading pharmaceutical promotions. Although the Bad Ad program is primarily directed towards healthcare providers, the general public can also anonymously report dubious ads to the FDA’s Office of Prescription Drug Promotion (OPDP), which runs the program. The new quiz is likely a part of more materials to come to help beef up the Bad Ad program, which has been receiving an increasing number of pharma ads for review over the last several years. The episode also features discussion about Pfizer and BioNTech’s announcement of the first trial results for their COVID-19 vaccine in young children between five and 11 years of age. The data shows that the vaccine is safe, well-tolerated and elicits robust immune responses in this age group. Despite the promising data, some parents may still be hesitant to vaccinate their young children according to a Kaiser Family Foundation survey. Hear about some of the factors that are influencing vaccine hesitancy among parents.   Read the full articles here: FDA Adds Quiz to Its Bad Ad Program to Combat Misleading Pharma PromotionsPfizer Shares Positive Data on COVID-19 Vaccine for Young Children, But How Willing Are Parents to Vaccinate Their Kids?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

FDA on COVID-19 Vaccine Boosters + Advocacy Group Pushes for Speedy FDA Approval of ALS Drug

In this episode, Ayesha discusses the FDA’s pending decision on authorizing COVID-19 vaccine boosters for the general public. While an FDA vaccine advisory committee voted against boosters for individuals 16 years of age and older last week, the FDA is still working towards its final decision on the matter. At the same time, the advisory panel recommended offering third doses of the Pfizer COVID-19 vaccine to those 65 years and older, as well as high risk individuals. The team discussed the need for boosters in light of the Delta variant and concerns of global vaccine inequities, but agree that vaccine boosters are not out of the norm and generally to be expected at some point.  The episode also features the ALS Association’s push for rapid FDA approval of Amylyx’s investigational ALS drug. The advocacy group cites the recent speedy approval of Biogen’s Aduhelm for Alzheimer’s disease, asking the FDA why similar regulatory flexibility is not being exercised for the ALS drug that could be life-changing for many ALS patients. The editorial team discusses the impact of the rapid approval of Aduhelm, as well as COVID-19 vaccines, as potentially driving changes in regulatory timelines, as more companies and patient groups may be demanding similar speedy approvals. Read the full articles here: FDA Remains Mum on COVID-19 Vaccine Boosters, But Acknowledges Third Dose Improves ImmunityALS Association Pressures FDA to Approve Amylyx Drug as Agency Cuts Phase III Trial RequirementFor 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

Eli Lilly to Develop RNA Editing Therapies + Study Shows Benefits of Daily Steps

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.Read the full articles here: Eli Lilly Pursues RNA Editing in New Partnership with ProQRHow Many Steps a Day Should You Actually Be Taking? New Study Shows Less May Be MoreFor 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

World’s First Smart Knee + Alzheimer’s Blood Test

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. Read the full articles here: How the World’s First “Smart” Knee Implant Aims to Change Knee Replacement RecoveryNew Study Shows Diadem’s AlzoSure Alzheimer’s Blood Test Can Predict Disease Years Before DiagnosisFor 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

Why Antimicrobial Resistance is a Silent Pandemic

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.Read the full article here: Why Antimicrobial Resistance is a Silent PandemicFor 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

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