In this episode, Ayesha spoke with Joshua Cohen and Justin Klee, co-CEOs and co-founders of Amylyx Pharmaceuticals, a company developing therapeutics for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).

Josh and Justin co-founded Amylyx Pharmaceuticals in 2013. Josh co-invented the oral, fixed-dose combination AMX0035 (known commercially as Albrioza in Canada and Relyvrio in the US), which is being explored for the potential treatment of neurodegenerative diseases. With a background in biomedical engineering, Josh is passionate about improving outcomes where there is a significant unmet need by pursuing research into novel drug candidates for ALS and other neurodegenerative diseases.

Justin previously conducted research in neural systems in the Moore lab at Brown University and in neurophysiology and Alzheimer’s disease under Dr. Rudolph Tanzi, founding member of Amylyx’ Scientific Advisory Board, at Harvard Medical School to explore new approaches to treating relentlessly progressive neurodegenerative diseases.

In 2020, Josh and Justin were named to Business Insider’s 30 Under 40 in Healthcare list and PM360’s ELITE in the Drug Researchers and Developers category among the many other awards they have won throughout their careers thus far.

Josh and Justin have overseen the growth of Amylyx from its start as a concept dreamed up in a dorm room at Brown University to a global, commercial stage and publicly traded pharmaceutical company hundreds of employees and headquarters in the US, Canada and the Netherlands to support Amylyx’s global operations.

Josh and Justin led the global regulatory approvals of AMX0035 for the treatment of ALS in Canada and the US. In April, Amylyx decided to remove the drug from the US and Canadian markets based on data from a confirmatory trial.

Tune into the episode to learn more about Amylyx’s plans for AMX0035, which include investigations in progressive supranuclear palsy (PSP) and Wolfram syndrome.

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In this episode, Ayesha spoke with Howard McLeod, PharmD, Director of the Center for Precision Medicine and Functional Genomics, Professor of Pharmacy and Medicine at Utah Tech University and Precision Medicine Advisor at the Geriatric Oncology Consortium; and Sharmeen Roy, PharmD, Chief Strategy and Science Officer at DoseMe, which is the world’s first and largest Bayesian dosing platform designed for clinical practice.

Precision dosing, also known as personalized dosing, aims to tailor drug dosages to the individual characteristics of each patient to achieve optimal therapeutic outcomes while minimizing adverse effects. It leverages various patient-specific factors, including genetics, age, weight, organ function and even lifestyle, to determine the most appropriate dosage for each individual. 

Dr. McLeod is an internationally recognized expert in precision medicine, who has made novel contributions at the discovery, translation, implementation and policy levels. Dr. McLeod received his Doctorate in Pharmacy from the Philadelphia College of Pharmacy and Science and completed his Post-Doctoral Training at St Jude Children’s Research Hospital and the University of Glasgow. 

Dr. Roy is passionate about leveraging technology to amplify the impact of the pharmacist. Her career spans pediatric clinical pharmacy, clinical research and pharmacogenomics with leadership roles at University of Chicago Medical Center and PipelineRx. She received her Doctor of Pharmacy degree from the University of Illinois at Chicago, is a Board-Certified Pharmacotherapy Specialist and completed a Pediatric Specialty Pharmacotherapy Residency at Texas Children’s Hospital.

Tune into the episode to learn more about the current landscape of precision dosing, including the latest technologies and tools designed to help optimize drug dosages.

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In this episode, Ayesha spoke with Margaret Froh, President of the Métis Nation of Ontario (MNO). Margaret is also a lawyer by training.    The Métis are a distinct Indigenous people recognized in s.35 of Canada’s Constitution. Métis communities have their own shared customs, traditions and collective identities that are rooted in kinship, their special aboriginal relationship to the land and a distinctive Indigenous culture and way of life that persists to the present day.    Cancer is a significant concern among Métis people in Ontario and across the Métis Nation Homeland, including women, as they experience higher cancer rates and lower cancer screening uptake than the non-Indigenous population.    Cancer Prevention Action Week, which took place during the third week of February, focuses on supporting and empowering people to make changes to their lifestyle and promoting routine cancer screening to reduce the risk of preventable cancers.    To help uncover and address cancer disparities among the Métis, Margaret has helped lead Métis-specific health research in collaboration with organizations like Ontario Health (formerly Cancer Care Ontario) and the Sunnybrook Research Institute.    Margaret is also a recent breast cancer survivor and by sharing her personal cancer story, is helping raise awareness about the importance of routine cancer screening among the Métis.    Tune into the episode to learn about the disproportionate impact of cancer on Métis communities and how Margaret’s leadership at the MNO is helping to drive changes to help improve cancer screening rates and better health outcomes.    For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/   Follow Us on Social Media

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This episode features an interview with Georgia Institute of Technology researcher Dr. Woon-Hong Yeo who has helped lead a team of researchers to develop a novel vascular monitoring system based on a specially designed smart stent. Hear about how the implantable smart stent system offers real-time and continuous monitoring of metrics like blood pressure and blood flow, as well as Dr. Yeo’s personal motivation for creating the vascular monitoring system to help people monitor their cardiac health. Dr. Yeo is a Woodruff Faculty Fellow; Associate Professor in Mechanical Engineering and Biomedical Engineering; and the Director of the Center for Human-Centric Interfaces and Engineering at Georgia Tech.

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In this episode, Ayesha and the editorial team spoke with Dr. Samantha Dale Strasser, chief scientific officer and co-founder of biotech start-up Pepper Bio. The company is working to develop therapeutics in the areas of oncology, neurodegenerative disease and inflammatory conditions using a ‘transomics’ drug discovery approach. This involves the integrated analysis of several layers of biological data, including genomic, proteomic, transcriptomic and phosphoproteomic data using novel transomics technologies involving lab methods and AI approaches. Hear more about Pepper Bio as well as Dr. Strasser’s journey from academia to the biotech industry.

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In this episode, Ayesha discussed the FDA approval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP). With the approval, Eli Lilly will be giving Novo Nordisk’s blockbuster diabetes injection Ozempic some tough competition. Hear about the projected sales of Mounjaro, data from studies that led to its approval and its impact from a patient perspective.

Ayesha also talked about the current monkeypox outbreak as clusters of cases continue to be reported in countries in Europe and North America. The US recently reported its first case of monkeypox, and all cases so far are linked to international travel. Learn more about monkeypox and how health authorities are asking people not to panic as most cases are mild and treatable. Also hear about how Britain is offering the smallpox vaccine to healthcare workers to help prevent infection from the monkeypox virus.

Read the full articles here: 

Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod

Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

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In this episode, Ayesha discussed a new study that evaluated a text messaging program designed to improve medication adherence and lifestyle factors among heart attack survivors. While the program did not lead to improvements in medication adherence, it did have a positive impact on lifestyle factors like diet. Hear more about the study and the importance of managing heart attack risk factors like hypertension and diabetes. This is especially relevant on World Hypertension Day (May 17) and May Measurement Month, which bring awareness to the importance of accurately measuring blood pressure.

Ayesha also talked about the FDA’s decision to place stricter restrictions on the use of Janssen/Johnson & Johnson’s COVID-19 vaccine given continuing concerns of the rare but serious side effect of blood clots. Hear about why the FDA revised the vaccine’s authorization, and why the FDA maintains that the vaccine’s benefits outweigh any known or potential risks.

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How Heart Attack Survivors Can Improve Lifestyle Factors with a Text Messaging Program

FDA Puts Further Restrictions on Use of Janssen/Johnson & Johnson COVID-19 Vaccine

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In this episode, Ayesha discussed Bristol Myers Squibb’s new heart drug Camzyos (mavacamten), which has received approval from the US Food and Drug Administration (FDA) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The drug is the first to target the pathophysiology of obstructive HCM and may be Bristol Myers’ next blockbuster cardiac drug. Hear more about the company’s looming patent cliff for some of its drugs as well as the company’s risk evaluation program for Camzyos given some of its safety concerns.

Ayesha also talked about a new ovarian cancer blood test developed by researchers at the University of Manchester that may help diagnose the disease quicker and more accurately, especially in younger women. The test includes a newer ovarian cancer biomarker that when used in combination with CA-125, the biomarker currently used to monitor and screen for ovarian cancer in some cases, could improve its diagnostic value. Learn more about the test and about the importance of women’s health advocacy in the early detection of diseases like ovarian cancer.

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Researchers Use Emerging Ovarian Cancer Biomarker to Develop New Blood Test for Ovarian Cancer

Camzyos Secures FDA Approval for Obstructive HCM, Bristol Myers Eyes it as its Next Big Cardiac Drug

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In this episode, Ayesha discussed the FDA approval of Mycovia Pharmaceuticals’ Vivjoa (oteseconazole) as the first approved treatment for recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection. The drug is indicated for women who permanently lack reproductive potential or are postmenopausal. The editorial team discussed the significant unmet need for this condition and how although many women’s health issues are now given greater spotlight, there still need to be more conversations around them. The episode marked World Maternal Mental Health Day and was sponsored by Elligo Health Research.

The editorial team also talked about the latest results of Eli Lilly’s investigational obesity drug tirzepatide, which demonstrated it could reduce body weight by an average of 20 percent in individuals without diabetes. Tirzepatide is a GLP-1 receptor agonist, a class of drugs designed to treat diabetes but at higher doses, can help with weight loss. Hear more about the drug and the obesity drug market, which is projected to grow to $5.42 billion in 2025.

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Oteseconazole (Vivjoa) Becomes First FDA-Approved Drug for Recurrent Yeast Infection

Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial

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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.

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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.

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BioNTech Partners with Matinas BioPharma to Develop New Delivery Technology for mRNA Vaccines

Pfizer to Acquire RSV Antiviral Developer ReViral in $525 Million Deal

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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.

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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 

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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.

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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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This episode features an interview with Bruce Culleton, MD, CEO, ProKidney, a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for chronic kidney disease. Prior to joining ProKidney in 2023, Dr. Culleton served as Vice President and General Manager at CVS Kidney Care and also worked in leadership roles at Becton Dickinson and Baxter healthcare. Before beginning his career in industry in 2007, Dr. Culleton was a Clinical Associate Professor in the Department of Medicine at the University of Calgary. ProKidney’s lead product candidate, REACT, is an investigational cell therapy designed to stabilize or improve kidney function in patients with chronic kidney disease with diabetes as the primary cause. The candidate is currently being evaluated in Phase II and Phase III clinical trials. To hear more about ProKidney’s cell therapy for chronic kidney disease, including developmental, manufacturing and regulatory considerations, tune into the episode. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/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 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. 

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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

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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.

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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

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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. 

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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

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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.

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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

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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.

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Sharing Colours on Rare Disease Day 2022

Why Black People Remain Underrepresented in Clinical Trials

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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.

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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

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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.

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UK’s NHS Backs World’s Costliest Drug Libmeldy for the Treatment of Rare Disease MLD

New Report Finds Whopping Increase in Pharma Cybersecurity Threats

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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.

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InBody’s New At-Home Blood Pressure Machine Allows for Real Time Monitoring

Eli Lilly Announces Nearly $1.5 Billion Investment into New Manufacturing Facilities in North Carolina and Ireland

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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. 

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Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic

Pfizer and Moderna Begin Trials for Omicron Targeting Vaccines

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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. 

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Gilead Sues Distributors Selling Counterfeit HIV Drugs

Menarini Diagnostics’ New COVID-19 Test Detects Variants Including Omicron

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In marking National Kidney Month, this episode features an interview with Robert Perkins, MD, Vice President, US Medical Affairs (Renal) at Bayer who spoke about kidney health and diabetes-inflicted chronic kidney disease. National Kidney Month is observed every March in the US to raise awareness about kidney health and promote preventive action. It aims to educate the public about the importance of kidneys to overall health and the risk factors for kidney disease, a major one being diabetes. At Bayer, Dr. Perkins is the strategic lead for a team of 8 HQ-based medical directors and a 40-member field medical team. He is responsible for evidence portfolio across two therapeutic indications, chronic kidney disease and heart failure, encompassing seven active trials and studies and more than 3,000 US patients. Dr. Perkins has also led the development and implementation of innovative digital educational outreach campaigns for primary care physicians. In previous roles, Dr. Perkins helped build and develop medical teams at Novartis and AstraZeneca. Last year, the American Diabetes Association (ADA) updated their standards of care guidelines for 2024, which outline strategies for diagnosing and treating diabetes (both type 1 and type 2) and outline methods of preventing and delaying type 2 diabetes as well as associated comorbidities like cardiovascular disease and chronic kidney disease. Tune into the episode to hear Dr. Perkins’ insights about current advancements and challenges in tackling chronic kidney disease, the updated ADA guidelines and how a comprehensive approach to treating diabetes is necessary for reducing the risk of kidney complications. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 talks about a new study from UCSF that shows how physical activity can maintain brain health in older individuals. The research shows that exercise increases levels of synaptic proteins in the brain involved in maintaining and strengthening neuronal connections. The researchers also found these proteins could be protective even in people with dementia and other neurodegenerative diseases like Alzheimer’s. The team talked about the benefits of moderate exercise like walking, and agree that even small steps can make a big difference!

The editorial team also discussed a new cardiac mapping system developed by Abbott that received clearance from the FDA for the treatment of cardiac arrhythmias. The device integrates the company’s proprietary mapping technology, which allows for the generation of more accurate electrograms of the heart. This helps better identify the precise location of an arrhythmia to be treated with catheter ablation therapy. Developing more powerful imaging tools is key to improving the diagnosis and treatment of heart conditions like cardiac arrhythmias.

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Abbott’s New Cardiac Mapping System Gets FDA Clearance for Treatment of Cardiac Arrhythmias

Study Shows Exercise Can Strengthen Neural Connections in the Aging Brain to Maintain Cognitive Health

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In this episode, Ayesha discussed a new blood test developed by researchers at the University of Oxford that can detect cancers and even if they’ve metastasized. The test is based on measuring metabolites produced by tumor cells in blood samples using nuclear magnetic resonance (NMR) spectroscopy. The researchers found that the test could identify cancer among healthy people, those with localized cancer and individuals with cancer that has metastasized. The test could help detect cancers even before the use of conventional imaging-based methods.

The editorial team also discussed Bayer’s commitment to 100 percent green packaging for its consumer products by 2030. The target is part of the company’s sustainability program, which includes shifting to renewable energy sources and sustainably sourcing recyclable and reusable paper materials. Bayer’s most popular consumer products like Aspirin, Aleve and Claritin will all have green packaging by the target year, which will also include recycling information that is consumer friendly. Other pharmaceutical companies like AstraZeneca, GSK and Biogen also have similar sustainability programs, reflecting the growing awareness of the pharmaceutical industry’s large carbon footprint and the importance of efforts to reduce it.

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Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis

Bayer Commits to 100 Percent Green Packaging by 2030

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In the first episode of 2022, Ayesha provided updates on Omicron and COVID-19 vaccine boosters. The FDA expanded authorization of booster doses of Pfizer’s COVID-19 vaccine to youth between 12 and 15 years of age, a third dose for immunocompromised children between five and 11 years old and a shorter wait time to get a booster for individuals 12 and older. Meanwhile, the CDC reduced isolation and quarantine periods by half to five days. The team discussed the implication of these updates and despite the direness of the current situation, expressed hope in seeing the pandemic finally end.

Ayesha also discussed some of the predicted trends in the life sciences in 2022. These include the continued promise of RNA-based vaccines and therapeutics like RNA editing for the treatment of various conditions including rare genetic diseases. Digital transformation in healthcare is another significant trend that will continue in 2022. Tools like wearable technologies, electronic data capture and integration of AI approaches are enabling the digital transformation of healthcare to help improve and revolutionize patient care.

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Key Trends in the Life Sciences to Look Forward to in 2022

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In this episode, which is the last episode for the year (the team will be back in January!), Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant indicated for the acute treatment of migraines in adults. The drug is similar to the company oral dose tablet (ODT) Nurtec but is the first CGRP receptor antagonist in a nasal spray formulation. Some of the editorial team members shared their experiences with migraine headaches, and talked about the pros and cons of an intranasal spray for helping treat them.

The team also talked about the first results from an early-stage trial evaluating Moderna’s new mRNA-based influenza vaccine. After the success of its mRNA COVID-19 vaccine, the company got to work on a quadrivalent vaccine against influenza. The trial results showed that the vaccine had no serious safety concerns and that it elicits an immune response against the four different strains of the influenza virus in the vaccine. The results of this were a bit mixed as there were greater levels of neutralizing antibodies against influenza A strain antigens than influenza B strain antigens. Moderna is also planning for a triple target vaccine against COVID-19, influenza and RSV.

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Biohaven Eyes FDA Approval for Second Migraine Drug Zavegepant After Promising Trial Results

Moderna Reveals Positive Results for its mRNA Influenza Vaccine

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In this episode, Ayesha discussed statements from Moderna and Pfizer regarding Omicron and the need for new variant-specific boosters. Moderna’s CEO sparked concerns when he said the current vaccines likely won’t be effective against Omicron, while Pfizer’s CEO said vaccines for COVID-19 will likely be needed for many years. The editorial team discussed the impact of these comments as they were relatively premature given that not much is known about Omicron yet, such as its transmissibility and potential for immune evasion. It’s important for companies to improve on their communications to ensure they’re evidence-based and don’t evoke unnecessary panic among people.

The team also talked about a new hepatitis B vaccine from VBI Vaccines that received FDA approval for adults. The vaccine is the first three-antigen hepatitis B vaccine approved in the US. While hepatitis B vaccination is recommended for all infants at birth now, this only began in the early 1990s. About 25 percent of adults in the US are not vaccinated for hepatitis B. The global hepatitis B vaccine market is expected to grow, particularly as several other hepatitis B vaccines were also approved by the FDA in the last couple of years. The World Health Organization (WHO) has laid out a goal to eliminate hepatitis B worldwide by 2030.

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Will the Current COVID-19 Vaccines Work Against Omicron? Pfizer and Moderna Spark Concern by Painting Bleak Pictures Prematurely

VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot

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In this episode, Ayesha discussed Omicron, the latest SARS-CoV-2 variant of concern. The editorial team talked about the emergence of variants amid low vaccine uptake in some parts of the world owing to vaccine inequities and vaccine hesitancy. Omicron’s transmissibility, severity and the effectiveness of the current vaccines against it remain unknown. Amid border closures and travel bans being instituted by countries worldwide, the team agreed that the pandemic isn’t over yet and new variants may be inevitable, which is why vaccination and other protective measures such as masks, physical distancing and hand hygiene continue to be important to help mitigate transmission.

The team also talked about Sagent Pharmaceutical’s voluntary recall of several lots of its injectable seizure medication levetiracetam due to potential loss of sterility because of a container closure issue on the vials it comes packaged in. The affected lots were distributed this year and affect reserve sample vials. The writers discussed how companies need to pay closer heed to the quality standards of manufacturers producing the packaging components for their pharmaceuticals, as the packaging of a drug product is critical to its integrity.

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Omicron Designated as a Variant of Concern by WHO: What We Know About It So Far

Seizure Drug from Sagent Pharmaceuticals Recalled Over Faulty Seal

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In this episode, Ayesha discussed the first FDA-approved virtual reality treatment for chronic lower back pain. The virtual reality system is called EaseVRx and is developed by virtual reality medtech company AppliedVR. The non-invasive treatment system is self-administered and is designed for at-home use. It consists of a virtual reality headset, controller and breath amplifier, and has preloaded software with cognitive behavioral therapy (CBT) and behavioral skill-based content including exercises and lessons as part of the treatment plan. The editorial team discussed the novelty of virtual reality treatments for conditions like chronic pain and depression as well as the benefits of at-home treatments as they offer convenience and reduce burdens on patients and caregivers.

The editorial team also talked about Canadian CDMO Biovectra’s recent announcement of its plans to build a biomanufacturing facility for large-scale production of mRNA therapeutics, including mRNA COVID-19 vaccines. During the pandemic, only a handful of production sites continue to produce the vaccines, which has led to global shortages, delays and distribution inequities. To address this, Biovectra is set to build the first domestic large-scale mRNA production plant in Canada with financial backing from the Canadian government. The company plans to produce doses of the current COVID-19 mRNA vaccines and also be equipped to produce mRNA therapeutics for future projects and potential health emergencies. 

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FDA Approves First Virtual Reality Pain Treatment

Biovectra to Build First mRNA Vaccine and Drug Manufacturing Plant in Canada

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In this episode, the editorial team had the opportunity to speak with Dr. Brett Wingeier, CEO of neuromodulation MedTech company Magnus Medical about the company’s Magnus System for the treatment of major depressive disorder (MDD). The neurostimulation device received breakthrough device designation from the US Food and Drug Administration (FDA) last month. The team heard from Dr. Wingeier about the challenges of treating depression and how neuromodulation shows clinical effectiveness for patients. Given this, he explained how the company decided to develop the Magnus System and described how it works. As a 20-year veteran in the field of neuromodulation, hear Dr. Wingeier’s insights into how the field continues to grow. 

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Magnus Medical’s Neurostimulation Technology Granted FDA Breakthrough Device Designation 

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In this episode, the editorial team discussed Pfizer’s new oral antiviral pill for the treatment of COVID-19. Pfizer released data from an interim analysis of a Phase III trial evaluating the drug, which shows that it can reduce the risk of hospitalizations by almost 90 percent. It also prevented COVID-19 related deaths in the study. The results were so strong that an independent data monitoring committee and the FDA told Pfizer they could stop enrolling participants in the trial. Ayesha and the team discussed the convenience of an oral medication for COVID-19, and how such drugs appear to be more accepted than preventative vaccines among some circles of people.

The podcast also features a discussion on the recent FDA approval of AbbVie’s eyedrop for the treatment of presbyopia, or age-related deficits in near vision. The condition is currently treated with prescription “reading glasses” or contact lenses. With almost half of all adult Americans having the condition, there is a significant market for new treatments in the area. The editorial team discussed the advantages of an eyedrop over glasses, and how personal preferences may dictate what patients choose. 

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Pfizer’s COVID-19 Antiviral Pill Cuts Hospitalizations by 90 Percent and May Eliminate All Deaths

FDA Approves AbbVie’s Vuity as the First Eyedrop for Presbyopia

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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.

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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 Changer

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In this featured episode of Xtalks People in Life Sciences, Ayesha spoke with Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance (PV) at Curis, a pioneering biotech company specializing in cutting-edge cancer therapies. Jain shared his journey into clinical safety and PV, highlighting key milestones along the way. Delving into his daily routine at Curis, he revealed his strategies for prioritizing tasks and staying informed of the latest developments in PV. Throughout the interview, Jain offered invaluable insights into career advancement in clinical safety and PV. He emphasized the indispensable skills and competencies vital for success in the field. Jain also discussed common challenges faced by PV professionals and suggested practical solutions. Aspiring professionals seeking to kickstart their careers in clinical safety and PV will find Jain’s insights informative. He provides actionable recommendations for gaining hands-on experience and navigating the PV landscape. Furthermore, Jain shares his expertise in establishing a PV department, particularly for emerging biotech firms. He outlines critical considerations for setting up an efficient PV system, especially in resource-limited environments. Listeners can also hear Jain’s thoughts on emerging trends in PV and his insights on how PV professionals can proactively prepare for the future. Tune in to this episode for a glimpse into the field of clinical safety and PV with Ashish Jain. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 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.

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Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar 

Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data 

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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. 

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Moderna Unwilling to Share COVID-19 Vaccine Formula Amid Vaccine Inequities

Singer Mary J. Blige Partners with Hologic to Raise Awareness About Early Breast Cancer Screening for Black Women

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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.

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How Researchers Stumbled Upon an Arthritis Vaccine Just in Time for World Arthritis Day

Medtronic Expands Two Insulin Pump Recalls, Including One Over Cybersecurity Concerns

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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.   

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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 

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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.   

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FDA Adds Quiz to Its Bad Ad Program to Combat Misleading Pharma Promotions

Pfizer Shares Positive Data on COVID-19 Vaccine for Young Children, But How Willing Are Parents to Vaccinate Their Kids?

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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. 

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FDA Remains Mum on COVID-19 Vaccine Boosters, But Acknowledges Third Dose Improves Immunity

ALS Association Pressures FDA to Approve Amylyx Drug as Agency Cuts Phase III Trial Requirement

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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.

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Eli Lilly Pursues RNA Editing in New Partnership with ProQR

How Many Steps a Day Should You Actually Be Taking? New Study Shows Less May Be More

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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. 

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How the World’s First “Smart” Knee Implant Aims to Change Knee Replacement Recovery

New Study Shows Diadem’s AlzoSure Alzheimer’s Blood Test Can Predict Disease Years Before Diagnosis

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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.

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Why Antimicrobial Resistance is a Silent Pandemic

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In this episode, Sarah presents three ways that Alzheimer’s trials will change now that Biogen’s Aduhelm (aducanumab) has been approved by the FDA. The team discusses whether placebo-controlled trials are still ethical and how ongoing dementia studies can manage patient attrition. Can trials pivot to allow patients to aducanumab as a background therapy?

The hosts also discuss how the price of aducanumab may limit patient access, and what it might take for payers to cover the cost of this pricey drug. 

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AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

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In this episode, Ayesha spoke with Jordyn Playne, President of the Métis Nation of Ontario Youth Council, a group of youth representatives from across Ontario who advocate on behalf of the concerns and interests of Métis youth at the provincial level. Jordyn is also a Clinical Consultant and Trainer at Waypoint Centre for Mental Health Care, as well as an advocate for cancer prevention. Jordyn has a Master’s degree in social work and licenses/certifications in cognitive behavioral therapy. To mark Cancer Prevention Action Week, which took place during the third week of February, Jordyn also shared a personal story to help raise awareness about the importance of cancer prevention, particularly among Indigenous communities like the Métis. Cancer is a significant concern among Métis people, including women, as they face higher cancer rates than the non-Indigenous population. Jordyn describes herself as a cancer “previvor,” as she took preventative action to reduce her risk of breast cancer. Tune into the episode to learn more about Jordyn’s story and her work in helping to improve health awareness and health outcomes among Métis youth and the greater Métis Nation. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 US Food and Drug Administration’s (FDA) authorization of a third dose of the Pfizer and Moderna COVID-19 vaccines for immunocompromised individuals. These individuals would primarily include organ transplant recipients, as well as patients taking immunosuppressive drugs for conditions like cancer and HIV/AIDS. Many people with weakened immune systems have been shown to have either low antibody titers, or none at all, after receiving a standard two-dose regimen of the Pfizer and Moderna COVID-19 vaccines. The FDA said additional vaccine doses for the general public are currently unwarranted. The editorial team discussed whether COVID-19 vaccine boosters could become a norm depending on how the SARS-CoV-2 virus, and the pandemic it has caused, evolves.

FDA Authorizes COVID-19 Vaccine Boosters for Immunocompromised Individuals

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In this episode, Ayesha discussed a presentation at this year’s Alzheimer’s Association International Conference (AAIC) 2021 about the impacts of COVID-19 on cognitive health. The study, conducted at New York University Langone Health, found that in cognitively normal COVID-19 patients that experienced the neurological symptom of confusion due to toxic-metabolic encephalopathy (TME), levels of serum biomarkers associated with neuroinflammation, neuronal injury and Alzheimer’s disease (such as phosphorylated Tau 181 and neurofilament light protein) were higher than in patients that did not have TME. The strong correlation of these serum biomarkers with the presence of neurological symptoms in COVID-19 patients suggest that COVID-19 patients could experience an acceleration of AD/ADRD symptoms and pathology.

Ayesha also discussed another story about serum biomarkers for the early detection of pancreatic cancer. Immunovia, a Swedish biotech firm, has developed a nine-panel biomarker blood test that can be used for the detection of pancreatic in early stages. The company’s American subsidiary, located in Massachusetts, received approval for the test early this month and the Massachusetts Department of Public Health has already begun using it to test patients for the deadly cancer. The test evaluates a combination of immunoregulatory and tumor biomarkers. Early detection of pancreatic cancer is a significant unmet clinical need because the cancer is typically diagnosed in late stages when treatment options are limited and the disease is difficult to treat.

AAIC 2021: Insights into COVID-19 Impacts on Cognitive Health

Immunovia’s Pancreatic Cancer Blood Test is World’s First for Early Disease Detection

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In this episode, Sarah talked about attending the Alzheimer’s Association International Conference (AAIC) 2021 virtually this year and discussed increasing diversity in Alzheimer’s clinical trials as an important topic that was part of the conference. Black and Hispanic people are more likely to be diagnosed with Alzheimer’s compared to Caucasians. Sarah outlined the results of some studies shared at the meeting, including a study that revealed people of minority backgrounds would be more likely to participate in a trial if they were directly invited to participate by someone of their own race, and if a family member had the disease. Exclusion criteria could also inadvertently exclude potential participants based on race, warranting the need for trial designs that foster greater inclusivity, including outreach tools, to broaden recruitment.

Related to the theme of racial inequities in healthcare as well as the health and beauty industry, Ayesha discussed a recent lawsuit launched against Johnson & Johnson over its iconic baby powder by a Black women’s advocacy group. The group claims that the company engaged in targeted marketing of their baby powder to Black and Hispanic women, whilst knowing for decades about asbestos impurities in their product; the company has been facing thousands of individual lawsuits over the years over links to use of the baby powder and ovarian cancer and mesothelioma. As part of the lawsuit, the advocacy group is calling on Johnson & Johnson to rectify its past ad campaigns by creating new adverts that are equitable and have “corrective marketing” that warn Black women of the risks associated with the product.

Read the full articles here: 

Diversity in Clinical Trials: Tackling the Issues in Alzheimer’s Research at AAIC 2021

Black Women’s Group Launches Lawsuit Against Johnson & Johnson Over Targeted Baby Powder Ads

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