Xtalks Life Science Podcast

In this episode, Ayesha talked about a safety warning issued by the US Food and Drug Administration (FDA) for Secura Bio’s Copiktra (duvelisib), which is a drug used to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). The FDA flagged the drug after evaluating long-term survival data, which showed that the drug was associated with a higher risk of serious side effects and a possibly increased risk of death. 

Ayesha also talked about a new nuclear magnetic resonance (NMR)-based molecular research tool for the assessment of the risk of Long COVID, including multi-organ damage and cardiovascular disease risk. The phenomics tool is being developed by Bruker for research purposes and is based on well-characterized metabolic and proteomic biomarkers associated with Long COVID. Hear more about the tool and how it can help patients receive appropriate treatment interventions early for Long COVID.

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Copiktra Blood Cancer Drug Gets FDA Warning Due to Increased Risk of Serious Side Effects and Death

Bruker Develops New Tool for Assessing Long COVID Risk

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In this episode, Ayesha discussed a new collaboration between leading medical technology company Becton Dickinson (BD) and CerTest Biotec who will work together to develop a molecular diagnostic test for the detection of the monkeypox virus. Learn about how BD will leverage its BD MAX platform to develop and validate CerTest’s under development monkeypox test amid an anticipated growing demand for testing given increasing cases of monkeypox infection around the world.

Ayesha also talked about the US Food and Drug Administration (FDA)’s amended authorizations for Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines to include children as young as six months old. The authorizations were based on the FDA’s analysis of efficacy and safety data in pediatric populations. Hear about the vaccine trials and parents’ attitudes towards vaccinating younger children.

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Monkeypox Test Kit in Development by Becton Dickinson in Partnership with CerTest Biotec

FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children Under Five After Unanimous Advisory Panel Support

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In this episode, Ayesha and the team talked about the FDA approval of Eli Lilly’s JAK inhibitor Olumiant for the treatment of alopecia areata, also commonly just known as alopecia. The drug has become the first approved systemic treatment for the autoimmune disorder that causes patchy hair loss. Hear about how alopecia has received mainstream recognition because of a recent infamous Hollywood incident and the importance of raising awareness about rare diseases like alopecia.

Ayesha also discussed the FDA approval of Alnylam’s RNAi therapeutic Amvuttra for the treatment of polyneuropathy associated with a rare protein disorder called hereditary transthyretin-mediated (ATTR) amyloidosis. Hear about how the drug is also being evaluated for another type of (ATTR cardiomyopathy) and the other big players in the ATTR space including Pfizer and AstraZeneca.

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Eli Lilly’s Olumiant Wins FDA Approval as First Systemic Treatment for Alopecia Areata

Amvuttra RNAi Therapeutic Wins FDA Approval for Rare Genetic Protein Disorder

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In this episode, Ayesha discussed new data shared by Eli Lilly for its weight loss injection tirzepatide. The drug was recently approved (under the brand name Mounjaro) by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes. The dual GIP/GLP-1 receptor agonist also has weight loss effects and recent analyses presented at the American Diabetes Association’s 82nd Scientific Sessions showed that almost 40 percent of participants lost a quarter of their body weight. Hear more about the newest data and industry predictions for tirzepatide as a rival to Novo Nordisk’s GLP-1 receptor agonist weight loss injection Wegovy.

The editorial team also discussed a new global biosimilars awareness campaign launched by Sandoz, Novartis’ biosimilars and generics drug division. The campaign is called Act4Biosimilars and will focus on improving the acceptability and accessibility to biosimilars, among factors, by 30 percent in over 30 countries by the year 2030. The campaign is aimed at addressing global health inequity and inequality by increasing access to advanced medicines like biosimilars. The team discussed the importance of education around biosimilars to help increase their acceptability and uptake.

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More Positive Data for Eli Lilly’s Diabetes and Weight Loss Injection Tirzepatide

Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

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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.

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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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