Xtalks Life Science Podcast

FDA Approval of Sanofi’s Enzyme Replacement Drug for ASMD + Disney Actress Partners with Medtronic for Diabetes Tech Campaign

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

Fitbit Introduces New Smartwatch with AFib Detection + FDA Approves Imbruvica for Pediatric Patients with cGVHD

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

FDA Approval of First Rapid-Acting Oral Depression Drug + Approval of $2.8 Million Gene Therapy for Rare Blood Disorder

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

Interview with Asaf Zviran, CEO of Cancer Genomics Company C2i Genomics

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

UK Approves First Omicron-Targeting COVID Vaccine + National Immunization Awareness Month

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

New COVID-19 Testing Technology + FDA Approves First Drug for HER2-Low Breast Cancer

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

FDA Approvals for Liquid Epilepsy Drug and a Vitiligo Medication

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

Towards a ’Functional Cure’ for Diabetes with Dr. Philip Toleikis, CEO, Sernova Corp

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

Expanded Approval for Gout Drug + Novavax COVID-19 Vaccine Gets FDA Authorization

In this episode, Ayesha discussed the FDA authorization of Novavax’s COVID-19 vaccine, making it the fourth authorized/approved COVID vaccine in the US. It is also the first protein-based COVID-19 vaccine to be authorized in the country. While the vaccine offers an alternate option to people who may still be hesitant about mRNA vaccines, hear why some experts think it won’t have much of an impact on those who are choosing to remain unvaccinated. Ayesha also talked about the expanded label approval of Horizon Therapeutics’ gout medication Krystexxa to include its co-administration with arthritis and chemotherapy drug methotrexate. The new approved combination is indicated for the treatment of uncontrolled gout, a rare condition in which patients fail to respond to conventional treatments due to problems including drug resistance. Hear more about gout and the rare condition of uncontrolled gout in this episode.Read the full articles here: Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19Krystexxa Chronic Gout Medication Gets Expanded FDA ApprovalFor 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 Issues Safety Warning for Blood Cancer Drug + Long COVID Risk Assessment Tool

In this episode, Ayesha talked about a safety warning issued by the US Food and Drug Administration (FDA) for Secura Bio’s Copiktra (duvelisib), which is a drug used to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). The FDA flagged the drug after evaluating long-term survival data, which showed that the drug was associated with a higher risk of serious side effects and a possibly increased risk of death. Ayesha also talked about a new nuclear magnetic resonance (NMR)-based molecular research tool for the assessment of the risk of Long COVID, including multi-organ damage and cardiovascular disease risk. The phenomics tool is being developed by Bruker for research purposes and is based on well-characterized metabolic and proteomic biomarkers associated with Long COVID. Hear more about the tool and how it can help patients receive appropriate treatment interventions early for Long COVID.Read the full articles here: Copiktra Blood Cancer Drug Gets FDA Warning Due to Increased Risk of Serious Side Effects and DeathBruker Develops New Tool for Assessing Long COVID RiskFor 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