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In this episode, Ayesha talked about World Immunization Week, which is celebrated during the last week of April every year. The theme of this year’s World Immunization Week is “Long Life For All,” which aims to communicate the importance of vaccines for a healthy and fulfilling life by protecting yourself and your loved ones against deadly diseases. Immunization programs were impacted by the COVID-19 pandemic but find out how immunization rates have been on the decline, particularly in developing countries, which have led to the resurgence of diseases like polio and measles.
The editorial team also discussed a new COVID-19 breathalyzer test that recently received emergency use authorization (EUA) from the US Food and Drug Administration (FDA). The mobile rapid test generates results in just three minutes from a sample of exhaled air. Hear more about how the test in the podcast, including how it works and about its high degree of sensitivity and specificity that edges out rapid antigen tests.
Read the full articles here:
World Immunization Week 2022: Long Life For All
First COVID-19 Breath Test Gets FDA Authorization
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In this episode, Ayesha discussed BioNTech’s new collaboration with Matinas BioPharma to explore the company’s lipid nanocrystal (LNC) delivery technology for mRNA vaccines. LNC structures are more stable than the lipid nanoparticle technology used in the current COVID-19 mRNA vaccines. Learn about how BioNTech hopes to leverage Matinas’ LNC platform to develop improved mRNA vaccines, including the possibility of orally administered vaccine formulations.
The editorial team also talked about Pfizer’s acquisition of RSV antiviral therapeutics company ReViral Ltd. in a $525 million deal. Pfizer made the purchase to help expand its RSV portfolio, which currently includes a candidate RSV vaccine that received breakthrough therapy designation from the FDA for the prevention of RSV in individuals 60 years of age and older. With the acquisition, Pfizer is looking to expand its infectious disease portfolio after the great success of its COVID-19 program.
Read the full articles here:
BioNTech Partners with Matinas BioPharma to Develop New Delivery Technology for mRNA Vaccines
Pfizer to Acquire RSV Antiviral Developer ReViral in $525 Million Deal
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Xtalks is marking World Parkinson’s Day (April 11) and Parkinson’s Awareness Month, which are observed every year to help raise awareness about the disease and the individuals living with it. To learn more about new Parkinson’s disease research, Ayesha discussed a new study by researchers at Rush University Medical Center that shows statins may help decrease the risk of parkinsonism in older adults. Hear about how parkinsonism relates to Parkinson’s disease and how the neuroprotective effects of statins could prevent Parkinson’s and related conditions.
The editorial team also discussed a new rapid molecular test developed by UK-based Genedrive PLC that can help physicians select the best antibiotic to treat babies with to prevent hearing loss. Gentamicin is the preferred treatment for newborns with infections like sepsis but about one in 500 babies have a genetic variant that makes them susceptible to gentamicin-induced hearing loss. Find out how the new genetic test can produce results in less than half an hour to help clinicians quickly determine the best course of treatment, and its rollout across a couple of NICUs in England.
Read the full articles here:
Parkinson’s Awareness Month: Statins May Lower Parkinsonism Risk in Older Adults
Genedrive’s Genetic Test Can Prevent Hearing Loss in Babies Through Personalized Treatment
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Ayesha shared insights she obtained from experts at NIH’s National Heart, Lung and Blood Institute (NHLBI) about clinical trial diversity. The panel of experts outlined some of the challenges in recruiting participants from minority and disadvantaged socioeconomic backgrounds, and talked about an NHLBI initiative based on community outreach that helped recruit more participants from traditionally underrepresented groups for COVID-19 vaccine trials.
The editorial team also talked about the theme of this year’s World Health Day 2022, which is “our planet, our health.” The theme relates to new WHO data that shows most of the world is breathing polluted air. This is of great significance and concern as environmental causes are a leading cause of death worldwide. Learn about the initiatives and updated guidelines that the WHO has issued to help address the worsening quality of air globally, and hear our team’s thoughts on how environmental responsibilities should be shared.
Read the full articles here:
Xtalks Voices: NIH Experts Share Insights on Increasing Clinical Trial Diversity
World Health Day 2022: WHO Data Shows 99 Percent of People Breathe Poor Quality Air
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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 Impurities
Jazz Pharma Announces $100 Million “Green” Manufacturing Plant for Cannabis-Based Medicines
For more life science and medical device content, visit the Xtalks Vitals homepage.
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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 Technology
Exact Sciences and Katie Couric Partner for Colon Cancer Awareness Month with Cologuard TV Ad
For more life science and medical device content, visit the Xtalks Vitals homepage.
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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 Past
Swift Medical Reveals New Imaging Device for Remote, Digital Wound Care
For more life science and medical device content, visit the Xtalks Vitals homepage.
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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 Day
Johnson & Johnson’s Carvykti Becomes Second FDA Approved Cell Therapy for Multiple Myeloma
For more life science and medical device content, visit the Xtalks Vitals homepage.
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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 2022
Why Black People Remain Underrepresented in Clinical Trials
For more life science and medical device content, visit the Xtalks Vitals homepage.
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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 Africa
FDA Authorizes Eli Lilly’s Bebtelovimab Which Demonstrates Activity Against Omicron
For more life science and medical device content, visit the Xtalks Vitals homepage.
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