Xtalks Life Science Podcast

In this episode, Ayesha discussed the FDA approval of bluebird bio’s Skysona for slowing the progression of neurologic dysfunction associated with the rare neurological disorder cerebral adrenoleukodystrophy (CALD) in boys four to 17 years of age with early, active CALD. The one-time administered gene therapy has also taken the title of being the world’s most expensive drug at $3 million. Hear more about the treatment and how the high prices of gene therapies can be alarming, but reimbursement programs are designed to pick up the costs.Ayesha also talked about the emergence of a new COVID-19 variant called BF.7 that the CDC is closely watching. The new strain of the coronavirus is a subvariant of the BA.5 Omicron variant. It appears to be more transmissible than other variants and subvariants and its incidence has doubled in just two weeks according to the latest CDC data. Find out more about BF.7 including how it could drive the new anticipated wave of COVID infections this fall.Read the full articles here:Bluebird Bio’s Skysona Receives FDA Approval and Becomes World’s Most Expensive DrugCDC Expresses Concern Over New COVID-19 Variant BF.7For 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

In this episode, Ayesha shared new research about how scientists at the Francis Crick Institute and University College London have found a mechanism of action to explain how air pollution may cause lung cancer in non-smokers. The research findings revealed that people who live in polluted areas have a higher risk of lung cancer, and that particulate matter smaller than 2.5 micrometers (PM2.5) can act on existing genetic mutations to trigger inflammation and the development of cancer. Hear more about the research findings in this episode.Ayesha also talked about how a woman with a unique ability to smell Parkinson’s disease has helped scientists develop a new test that may aid in the early diagnosis of the condition. The Scottish woman was able to detect something was off with her husband’s body odor more than a decade before he was diagnosed with Parkinson’s disease. Find out more about how researchers leveraged her powerful sense of smell to develop the new test.Read the full articles here:New Research Reveals How Air Pollution May Trigger Lung CancerScientists Develop Test for Parkinson’s Based on Woman’s Ability to Smell the DiseaseFor 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

In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients. The drug is administered intravenously every two weeks and in clinical trials, demonstrated significant improvements in lung function as well as reductions in spleen and liver sizes. Hear more about the rare, fatal disease and the new drug approval for it.Ayesha also talked about Medtronic’s new partnership with former Disney star Jennifer Stone on a new ad campaign for its diabetes tech, including the smart insulin injector InPen. Hear about Jennifer’s story as a type 1 diabetes patient and how the InPen helps patients like her simplify their diabetes management. Through the ad campaign, Medtronic is hoping to increase awareness about advanced diabetes tech like the InPen. The company is also working on new connected tech to integrate its different diabetes device offerings.Read the full articles here:Sanofi’s Enzyme Replacement Therapy Xenpozyme Wins FDA Approval for Rare Disease ASMDMedtronic’s InPen Gets Backing from Disney Star Jennifer Stone in Diabetes Tech CampaignFor 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

In this episode, Ayesha discussed Fitbit’s new lineup of smartwatches that is set to release this fall, including the Sense 2 which has a sensor for the detection of atrial fibrillation (AFib). Fitbit said the Sense 2 is its most advanced health-focused smartwatch to date. The device has a sensor that can identify signs of AFib through the company’s electrocardiogram (ECG) app and photoplethysmography (PPG) algorithm. Hear more about the AFib detection feature as well as the smartwatch’s new Body Response sensor for stress management. Ayesha also discussed the FDA approval of Imbruvica (ibrutinib) for pediatric patients one year of age and older with chronic graft-versus-host disease (cGVHD). This is the BTK inhibitor’s first approval for a pediatric indication, and the first approved liquid form of the drug. The approval addresses an unmeet need in this indication, as treatment options for cGVHD in younger children are limited. Learn more about the approval in this episode of the Xtalks Life Science Podcast.Read the full articles here:Fitbit Sense 2 Smartwatch with AFib Detection to Launch This FallImbruvica Wins Milestone Approval for Children as Young as 1 With Chronic GVHDFor 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

In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). The approval makes Auvelity the first and only rapid-acting oral medication for depression, and the first and only oral NMDA receptor antagonist approved for MDD. Hear more about the approval, including clinical trial data showing the treatment can take effect in as little as one week, and how it is the first antidepressant approved in over 60 years that has a new mechanism of action.Ayesha shared news about another significant FDA approval for a gene therapy to treat transfusion-dependent beta thalassemia. Bluebird bio was awarded the approval for its gene therapy Zynteglo (beti-cel), which is a one-time treatment for the rare blood disorder. Hear more about the therapy, some of the setbacks bluebird has had to face on the road to its approval and why the treatment has a steep price tag.Read the full articles here:Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for DepressionBluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta ThalassemiaFor 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

This episode features an interview with Dr. Asaf Zviran, CEO and co-founder of C2i Genomics, a biotech company focused on improving cancer detection and monitoring using genomics- and AI-based approaches. Hear about the company’s proprietary cancer surveillance technology, how Dr. Zviran’s founded C2i Genomics, including a personal story, and how the company is focused on truly personalizing cancer treatments.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

In this episode, Ayesha discussed the UK’s approval of Moderna’s next generation COVID-19 vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant of concern. Hear more about the bivalent booster shot, including clinical trial data that led to its approval. Also, hear what Moderna officials have to say about the administration schedule of the new shot.Ayesha also talked about National Immunization Awareness Month, which is marked every August in the US. Health agencies like the FDA and CDC are not only on the regulatory side of vaccines, but are also committed to helping raise awareness about the importance of vaccines among the public. As part of this, the health agencies suggest healthcare providers should 'strongly recommend' vaccines. Vaccine 'catch up' campaigns are also important now since other non-COVID vaccinations, including routine childhood vaccinations, have lagged during the pandemic. Read the full articles here:  UK Approves First Omicron-Targeting COVID-19 BoosterNational Immunization Awareness Month: Vaccines Work and Catching UpFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social Media

In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. The new test is as sensitive and accurate as PCR tests and faster than lateral flow (rapid antigen) tests. Hear about the innovative new technology underlying the molecular test, and how the test is also being developed for the detection of other viruses. Ayesha also talked about the FDA approval of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The approval makes Enhertu the first approved drug for this indication. Find out about the trial data that led to the approval and its effectiveness in HER2-low breast cancer, which is a newer subtype of the cancer.Read the full articles here: Innova Secures Licensing Rights for U of Birmingham’s New COVID-19 Test Technology RTF-EXPARAstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast CancerFor 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

In this episode, Ayesha discussed the FDA approval of Azurity Pharmaceutical’s Zonisade (zonisamide oral suspension) as an adjunct therapy for the treatment of seizures in adults and pediatric patients 16 years of age and older with epilepsy. The drug is the first FDA approved oral suspension form of zonisamide. Hear about how the drug could help increase accessibility and flexibility for epilepsy patients and improve treatment adherence.Ayesha also talked about biopharmaceutical company Incyte’s new vitiligo drug Opzelura that recently received FDA approval for the treatment of nonsegmental vitiligo. The topical medication is the first approved treatment for repigmentation in vitiligo and also the first approved topical JAK inhibitor in the US. Hear more about raising awareness about rare diseases like vitiligo and how it can help foster the development of new treatments. Read the full articles here: Zonisamide Liquid Form Gets FDA Approved for Epilepsy TreatmentOpzelura Vitiligo Med Wins FDA Approval as First Treatment for RepigmentationFor 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

In this episode, the editorial team spoke with the President and CEO of regenerative medicine biotech Sernova Corp Dr. Philip Toleikis to learn more about how the company is developing a ‘functional cure’ for diabetes. The team heard from Dr. Toleikis about Sernova’s proprietary Cell Pouch System that is designed to house therapeutic cells. Dr. Toleikis spoke about the latest clinical trial data for the medical device, and also about the company’s new partnership with Evotec to integrate its insulin-producing cells in the Cell Pouch System.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