Xtalks Life Science Podcast

Pfizer Recalls Blood Pressure Medication + Jazz Pharma Manufacturing Cannabis-Based Medications

In this episode, Ayesha discussed Pfizer’s voluntary recall of several lots of its blood pressure medication Accuretic and two generic versions of it due to higher than acceptable levels of a carcinogenic nitrosamine compound. The recall affects lots produced between November 2019 and March 2022. The editorial team discussed the increasing frequency of recalls of commonly prescribed drugs like blood pressure and diabetes medications. Should companies and regulators share more information about the steps being taken to address the issue of drug impurities?The editorial team also talked about Jazz Pharmaceutical’s new $100 million manufacturing facility in the UK dedicated to the production of cannabis-based medicines. This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication. Construction on the facility has commenced and Jazz says it is committed to it being environmentally sustainable at all stages of development and use. Find out how Jazz is going green with its new cannabis-based drug manufacturing facility. Read the full articles here: Accuretic Blood Pressure Drug and Two Generics Recalled by Pfizer Over Carcinogen ImpuritiesJazz Pharma Announces $100 Million “Green” Manufacturing Plant for Cannabis-Based MedicinesFor 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

Exact Sciences and Katie Couric’s Colon Cancer Awareness TV Ad + Alnylam Sues Pfizer and Moderna Over Patent Infringements

In this episode, Ayesha shed light on National Colorectal Cancer Awareness Month by talking about a new colon cancer screening campaign from Exact Sciences that features a TV ad with Katie Couric. Couric, who is a long-time advocate of colon cancer screening after her husband passed away from colon cancer over 20 years ago, continues her mission to help raise awareness about the importance of early screening for the disease. Exact Sciences’ campaign is appropriately called “Mission to Screen” and includes a TV commercial featuring Couric and her daughter, along with other people that Couric is seen speaking to about their reasons for screening for colon cancer. The ad highlights Exact Sciences’ Cologuard, a DNA-based stool test for colon cancer detection.The editorial team also learned about Alnylam Pharmaceuticals’ lawsuits against mRNA COVID-19 vaccine makers Pfizer and Moderna over patent infringements. Alnylam claims it invented the lipid nanoparticle delivery technology used in the vaccines and is seeking “fair compensation” for its use. Moderna hit back at Alnylam, accusing it of “blatant opportunism” and saying that it has worked for years on a different version of the RNA delivery technology. The editorial team said it was difficult to take sides in this case without all of the evidence/information, but it isn’t difficult to “believe” Moderna as it has been developing RNA vaccines for over a decade.Read the full articles here: Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery TechnologyExact Sciences and Katie Couric Partner for Colon Cancer Awareness Month with Cologuard TV AdFor 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

Johnson & Johnson Funding Human Asbestos Studies + Swift Medical’s Imaging Device for Remote Digital Wound Care

In this episode, Ayesha talks about new revelations about how Johnson & Johnson funded studies in the early 1970s that involved injecting prisoners in a Pennsylvania jail, most of whom were Black, with asbestos. The company wanted to compare the effects of asbestos versus talc, one of the main ingredients in Johnson & Johnson’s baby powder, on the skin. The company says it regrets backing the human asbestos experiments but says such human testing was common back then. The editorial team discussed Johnson & Johnson’s ongoing legal battles over its baby powder and how it could have better handled the recent revelations by not having made excuses for the asbestos studies.The editorial team also discussed a new medical imaging device from Swift Medical for digital wound care and other skin conditions. The device fits on top of the camera of a cell phone and uses advanced imaging technology to capture “beneath-the-skin” images of the skin. Swift Medical says the device was designed to make wound care accessible for all patients, regardless of skin type and at any beside or clinical location. The images can be accessed by healthcare providers through an accompanying phone app to allow for remote monitoring and care. The team discussed the significant prevalence of chronic wounds, particularly associated with chronic conditions like diabetes, and how the device offers a great means of accessing information and care right from a cell phone. Read the full articles here: Johnson & Johnson Remorseful Over Funding Human Asbestos Experiments, But Says They Were Common in the PastSwift Medical Reveals New Imaging Device for Remote, Digital Wound CareFor 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

Celebrating Women’s Leadership in Life Sciences on International Women’s Day + Johnson & Johnson’s Cell Therapy for Multiple Myeloma Gets FDA Approval

In this episode, Ayesha spoke about some of the top women leaders in life science industries in celebration of International Women’s Day. While women remain underrepresented in STEM and life science industries, there are more women in leadership positions at pharmaceutical, biotechnology and medical device companies than ever before. Studies also show that women’s leadership training programs provide effective training for women seeking executive-level positions. The editorial team also shared some of their experiences and insights as women in the life sciences. The editorial team also learned about the FDA approval of a new CAR T cell therapy developed by Johnson & Johnson and Legend Biotech for the treatment of relapsed or refractory multiple myeloma. The drug, called Carvykti, is administered as a single infusion and indicated for patients who have not responded to previous treatments. The cell therapy has a list price of almost half a million dollars due to the high development costs of cell therapies, but makers say the clinical benefit they offer is worth the price. Most insurers and Medicare will cover the cost of Carvykti.Read the full articles here: Looking at Women’s Leadership in Life Science Industries on International Women’s DayJohnson & Johnson’s Carvykti Becomes Second FDA Approved Cell Therapy for Multiple MyelomaFor 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

Marking Rare Disease Day 2022 by Sharing Colours + Why Black People Remain Underrepresented in Clinical Trials

In this episode, the editorial team discussed Rare Disease Day which is celebrated every year on February 28 (or February 29 in leap years). This year’s theme was “Share Your Colours,” where individuals with rare diseases were encouraged to share their experiences and aspirations to help raise awareness. The campaign from rarediseaseday.org included a touching video in which patients with rare diseases shared their stories. The editorial team discussed the encouraging growth seen in recent years in rare disease clinical research in the life science industries, providing hope for improved diagnosis, care and treatments for patients with rare diseases.To mark the end of Black History Month, the team also talked about the underrepresentation of Black people in clinical trials. Although Black people are disproportionately affected by certain diseases due to a combination of socioeconomic and genetic factors, their rates of participation in clinical trials remain concerningly low. In the US, Black people only constitute five percent of all clinical trial participants. Studies show historic medical mistrust among Black people for healthcare systems is the major barrier to trial participation, along with socioeconomic barriers and a lack of patient education. Community outreach and active engagement by the medical and scientific communities are key to improving clinical trial participation among Black people.This week’s Xtalks Life Science Podcast was sponsored by Elligo Health Research.Read the full articles here: Sharing Colours on Rare Disease Day 2022Why Black People Remain Underrepresented in 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

BioNTech Unveils Modular mRNA Factories for Africa + FDA Authorizes Eli Lilly Monoclonal Antibody Effective Against Omicron

In this episode, Ayesha discussed BioNTech’s new modular mRNA factories, called the BioNTainer, that are destined for Africa to help boost COVID-19 vaccine supplies on the continent. The modular production units are housed in containers that come equipped with raw starting materials and state-of-the-art technology for producing mRNA-based vaccines from start to finish, except for the fill-and-finish step, which will be carried out by local manufacturers. Despite most African leaders welcoming the container factories, there is some controversy over BioNTech’s “paternalistic” control over production of its vaccine, especially since it continues to resist calls for patent waivers for its vaccine.The team also talked about Eli Lilly’s new COVID-19 monoclonal antibody bebtelovimab that received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) indicated for patients with mild to moderate COVID-19 who are at risk of progressing to severe disease. The treatment replaces Eli Lilly’s previous monoclonal antibody cocktail of bamlanivimab and etesevimab, which was pulled by the FDA over a lack of effectiveness against the Omicron variant. Lilly’s new monoclonal antibody has shown neutralizing activity against Omicron in lab studies so far. The US Department of Human Health Services (HHS) is making it available to patients free of charge. The team discussed how quickly the new monoclonal antibody was developed, showing that companies like Eli Lilly are continuing to work on new iterations of COVID-19 treatments and vaccines in the face of new emerging variants. Read the full articles here: BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in AfricaFDA Authorizes Eli Lilly’s Bebtelovimab Which Demonstrates Activity Against OmicronFor 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’s NHS Backs World’s Costliest Drug for Treatment of MLD + Report Finds Increase in Pharma Cybersecurity Threats

In this episode, Ayesha discussed the NHS’s recommendation of Libmeldy, a gene therapy for the treatment of the rare disease MLD, which is officially the world’s most expensive drug with a list price of almost $4 million USD. The drug was developed by Orchard Therapeutics and the NHS was able to negotiate a greater discount on it with the company so that it can offer it to patients in England. Libmeldy was initially rejected by the drug price watchdog NICE in England over its exorbitant price. The editorial team discussed the high costs associated with orphan drugs and how both governments and pharma companies must work together to make them accessible to patients. The team also talked about a digital risk report that revealed the existence of significant cybersecurity vulnerabilities among the world’s top pharma companies. These include breaches and leakages of items like email addresses, passwords and even credit/banking information. Moreover, a significant percentage of breaches and record exposures occurred after 2020 and worsened in 2021 during the height of COVID-19 vaccine distribution efforts. Widespread cybersecurity breaches can lead to high-level attacks such as ransomware or coordinated disinformation campaigns. The team discussed how cyberattacks could hit almost every aspect of a pharma company’s operations, from R&D through to supply chains, and how this necessitates greater investments in cybersecurity infrastructure.Read the full articles here: UK’s NHS Backs World’s Costliest Drug Libmeldy for the Treatment of Rare Disease MLDNew Report Finds Whopping Increase in Pharma Cybersecurity ThreatsFor 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

Inbody’s At-Home Real Time Blood Pressure Monitoring + Eli Lilly Announces Investments into New Manufacturing Facilities

In this episode, Ayesha talked about a new at-home blood pressure monitor developed by Inbody that can track blood pressure in real time. The device uses the automated oscillometric method, commonly used in clinical settings now, to generate mean arterial pressure and calculate systolic and diastolic blood pressure from it using an algorithm. The device has a one-touch cuff and can be synced to Inbody’s mobile app, which allows users to access a digital health report outlining their blood pressure readings. This can help identify blood pressure fluctuations that could be indicative of heart conditions. The team discussed the convenience of at-home health monitoring and how it can allow individuals to better manage their health.The editorial team also discussed Eli Lilly’s nearly $1.5 billion investment into building new manufacturing facilities in the US and Ireland. The pharma giant said the investment will allow the company to expand its manufacturing capacities, particularly in light of new therapeutics it is developing in areas including Alzheimer’s, diabetes, cancer and autoimmune conditions. The pharma giant is anticipating an FDA approval for its Alzheimer’s drug donanemab this year. The new US site will be in North Carolina and the Irish plant will be in Limerick, both home to institutes, universities and companies involved in STEM-based research.Read the full articles here: InBody’s New At-Home Blood Pressure Machine Allows for Real Time MonitoringEli Lilly Announces Nearly $1.5 Billion Investment into New Manufacturing Facilities in North Carolina and IrelandFor 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 for First TCR Therapy for Uveal Melanoma + Pfizer and Moderna Begin Trials for Omicron Booster

In this episode, Ayesha talked about the recent FDA approval for Immunocore’s Kimmtrak for the treatment of a rare type of eye cancer called uveal melanoma. Not only has the treatment become Immunocore’s first commercial product, but it has also become the first approved treatment for uveal melanoma and the first ever approved T cell receptor (TCR) therapeutic. Kimmtrak is priced at $400,000 per treatment course, and Immunocore has created a program to help make it accessible to patients. The editorial team discussed that while it is encouraging that therapeutic development in rare disease research has been increasing, the high cost of the treatments can be a significant barrier to access.The editorial team also discussed how Pfizer and Moderna have commenced trials for their respective omicron-based vaccines. The companies announced that studies for their respective omicron targeting boosters had begun, and Moderna dosed its first trial participant last week. Given omicron’s significantly heightened transmissibility compared to other SARS-CoV-2 variants, and the reduced effectiveness of the current versions of the vaccines against it, the team discussed that it made sense to have an omicron-specific booster for better individual protection and to help curb transmission. Read the full articles here: Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor TherapeuticPfizer and Moderna Begin Trials for Omicron Targeting 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

Gilead Sues Over Counterfeit HIV Drugs + Menarini’s New Rapid COVID-19 PCR Test

In this episode, Ayesha discussed Gilead Science’s lawsuit against a network of distributors selling counterfeits of the company’s best-selling HIV drugs Biktarvy and Descovy. The drugs were being sold in pharmacies across several states. Gilead said it had been working with the US Marshals and local law enforcement to conduct seizures of over 85,000 bottles of the counterfeit drugs. Gilead says it’s taking action to ensure the counterfeits are removed from circulation. The editorial team talked about the significant dangers of counterfeit drugs with respect to patient safety and that stricter regulations around tracking and audits at pharmacies should be implemented to prevent the distribution of counterfeit products.The editorial team also discussed Menarini Diagnostics’ new PCR-based COVID-19 test that can detect all of the variants of SARS-CoV-2, including Omicron. Read the full articles here: Gilead Sues Distributors Selling Counterfeit HIV DrugsMenarini Diagnostics’ New COVID-19 Test Detects Variants Including OmicronFor 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