Xtalks Life Science Podcast

FDA Authorizes Pfizer COVID-19 Vaccine for Children 5 to 11 + Genentech’s Drug Delivery System for Macular Degeneration

In this episode, Ayesha discusses the FDA’s authorization of Pfizer/BioNTech’s COVID-19 vaccine for children between five and 11 years of age. The authorization was based on trial data that showed the vaccine was safe, well-tolerated and induced robust immune responses among children in this age group; side effects were generally mild to moderate. Amid concerns of the rare adverse event of myocarditis in children and adolescents following vaccination with mRNA vaccines, the FDA conducted its own benefit-risk analysis that showed the benefit of vaccination outweighs the risk of myocarditis. The editorial team discussed the positive trial data, the importance of vaccinating kids amid rising infections among younger children, as well as vaccine hesitancy among parents.The team also learned about the FDA approval of Genentech’s new ocular implant drug delivery system, called Susvimo, for the treatment of neovascular, or wet, age-related macular degeneration (nAMD). The implant is surgically placed in the eye and injected with Genentech’s anti-VEGFA monoclonal antibody ranibizumab for continuous delivery. Compared with the current standard of care of near monthly intravitreal anti-VEGF injections, the ocular implant only has to be refilled every six months. The team discussed the convenience of the device, but also potential patient hesitancy over the surgery for its implantation.Read the full articles here: FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine for Kids 5 to 11 Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game ChangerFor 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 Approves Interchangeable Humira Biosimilar + Gene Silencing Treatment for Porphyria Gets Nod From England’s NICE

In this episode, the editorial team discusses the FDA approval of Cyltezo as the first interchangeable biosimilar for AbbVie’s Humira. The approval lends to the growing Humira biosimilars market, which will take off in 2023 with Boehringer Ingelheim’s Cyltezo and biosimilars from Amgen, Merck and Alvotech. AbbVie has been facing a lot of heat over accusations of price gouging and patent abuses to block Humira biosimilars from entering the market. The team had an interesting discussion about public perceptions of generics and biosimilars versus their originals/reference products.Ayesha also talked about a new gene silencing treatment for porphyria called Givlaari that received recommendation from England’s NICE after having been initially rejected by the health watchdog last year. Additionally, long-term results from a late-stage trial for Givlaari were recently released, which showed that the treatment provides sustained benefit and has a good safety profile. However, the team discussed the high cost of the treatment, which is a concern for patients in countries that don’t have some form of socialized healthcare.Read the full articles here: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data 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

Moderna Unwilling to Share COVID-19 Recipe + Singer Mary J Blige Partners with Hologic for Breast Cancer Awareness

In this episode, the editorial team talks about Moderna’s unwillingness to share its COVID-19 vaccine formula with other countries, namely low- and middle-income countries who continue to face issues accessing COVID-19 vaccines. The company said it would be more efficient for it to aim to produce more of the vaccines themselves to deliver to poorer countries. While developing countries continue to call for IP waivers on COVID-19 vaccines, and vaccine makers like Pfizer and Moderna resisting the calls, it’s important to note that it isn’t so easy to set up the specialized manufacturing facilities needed for production of mRNA vaccines. The team discusses these issues in the face of global vaccine inequities.Ayesha also talked about Grammy award-winning singer Mary J. Blige’s efforts to help raise awareness about breast cancer during breast cancer awareness month this October. As part of her efforts, the entertainer teamed up with MedTech company Hologic, which is leading initiatives to promote equitable healthcare for women. Blige shared how breast cancer has personally affected her with the passing of her aunt from the disease, the problem of cancer not being discussed in Black communities and the fact that the disease has a 40 percent higher mortality among Black women compared to white women. Blige wants to help change this by raising awareness of the importance of early detection through annual mammograms, as well as increasing inclusion of Black women in clinical trials. Read the full articles here: Moderna Unwilling to Share COVID-19 Vaccine Formula Amid Vaccine InequitiesSinger Mary J. Blige Partners with Hologic to Raise Awareness About Early Breast Cancer Screening for Black WomenFor 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

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