Xtalks Life Science Podcast Xtalks

In this episode, Ayesha talked about the FDA approval of the first topical gene therapy for the treatment of a rare skin condition. Krystal Biotech’s Vyjuvek is a topical gene therapy that has been approved for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB). It’s the first treatment for the rare disease. Hear more about DEB and Vyjuvek in this episode.
Ayesha and the team also discussed the FDA approval of Bausch + Lomb’s first prescription drug for the treatment of dry eye disease. The drug, called Miebo, is also the first treatment that targets tear evaporation, which is a leading cause of dry eye disease. Hear more about the drug and its approval in the show.
Read the full articles here:
Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin Disease
Miebo Approved as First Dry Eye Disease Treatment to Target Tear Evaporation
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.) during or after the menopausal transition. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life. The team discussed Veozah and the benefits of this drug for women’s health.
Vera and the team also discussed the recent FDA approval of Allergan Aesthetics’ new hyaluronic acid product, SkinVive by Juvéderm, for achieving skin smoothness. SkinVive will be the first and only intradermal microdroplet injection of hyaluronic acid available in the US, representing a significant milestone in skincare innovation. The team discussed the benefits and novelty of the product, as well as their personal opinions of hyaluronic acid products for skincare and the costs of such treatments.  
Read the full articles here:
Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes
SkinVive by Juvéderm: The New Dermal Filler Coming to the US
See the related webinars here:
Hot Flashes, Brain Fog and the Blues: Frontiers in Menopause Treatments
Innovations in Skin Care Ingredients: Beauty from Within, Wellness Throughout
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Sarah interviews Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis, about the challenges of bring biosimilars to market. Dr. Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines. 
Sarah and Dr. Woollett also discuss Samsung Bioepis’ first US Biosimilar Market Report (linked below) and some of its key findings on biosimilar cost savings, uptake and market share. She also shares the way forward to help biosimilars see broader use both in the US and Europe.
Read about the publications mentioned in this episode here:
Samsung Bioepis’ First US Biosimilar Market Report
A 'Global Reference' Comparator for Biosimilar Development
An Efficient Development Paradigm for Biosimilars
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance
Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One
The Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right Question
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. RSV is a respiratory virus that causes mild to moderate cold and flu-like symptoms, but it can cause complications like lower respiratory tract disease (LRTD) and pneumonia in older adults and young children. Read more about the vaccine, including clinical trial results on its efficacy and safety. 
Ayesha and the team also discussed the FDA approval of Qalsody (tofersen), a novel, first-of-its-kind treatment for ALS. The treatment, an antisense oligonucleotide developed by Biogen, targets abnormal proteins arising from SOD1 mutations, which are associated with the development of ALS in some patients. Even though these mutations only account for two percent of ALS cases worldwide, the treatment is an important milestone that sets the stage for the development of more ALS therapies.
Read the full articles here:
Arexvy Becomes World’s First RSV Vaccine
Qalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALS
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Vera talked about how a couple of direct-to-consumer TV commercials have helped a medical device company, Axonics, establish its reputation in the non-drug incontinence therapy space. Around 87 million adults in the US and Europe have overactive bladder and it is estimated that an additional 40 million adults have fecal incontinence. Axonics offers innovative sacral neuromodulation (SNM) systems that are approved by the US Food and Drug Administration (FDA) for the treatment of bladder and bowel dysfunction. The team discussed Axonics Therapy and the occurrence of non-drug (medical device) TV ads.

Vera and the team also discussed how two companies, Cerner Enviza and John Snow Labs, are teaming up with the FDA to use AI tools to better understand the side effects of drugs. This project is part of the FDA’s Sentinel Initiative to evaluate the effects of medicines on real-world populations. Hear more about how Cerner Enviza and John Snow Labs will use AI to explore the mental health side effects of a commonly prescribed asthma drug, Singulair (montelukast)

Read the full articles here:

Axonics Touts Non-Drug Incontinence Therapy in TV Ads

How Cerner Enviza Will Use AI To Study the Mental Health Side Effects of Montelukast

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Cody Simmons, CEO of DermaSensor, a health technology company that aims to launch the world’s first point-and-click skin cancer detection tool for primary care providers.

The skin cancer evaluation tool, also called DermaSensor*, is a point-and-click device that can provide health care practitioners with a skin evaluation in seconds. 

As a bioengineer and entrepreneur, Cody has spent all of his career bringing new health technologies to physicians and patients. Prior to joining DermaSensor, Cody led commercial efforts for a Silicon Valley medical device screening and monitoring startup. He began his career in business development and commercial strategy roles at Genentech.

Hear more about the innovative technology and application of DermaSensor in this episode. And view a video excerpt of the device in action here: https://youtu.be/4-NnRcyOFHc

Read more at: Clinical Studies Support DermaSensor’s Skin Cancer Detection Device

*FDA submission pending review. DermaSensor is currently not for sale in the United States.

References

1. Merry SP, Croghan I, McCormick B, Chatha K, Leffell D. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial [Initial Results]. Poster Presentation, Innovations in Dermatology Conference, Las Vegas, NV, November 3-5, 2022.

2. Carli P, Nardini P, Crocetti E, De Giorgi V, Giannotti B. Frequency and characteristics of melanomas missed at a pigmented lesion clinic: a registry-based study. Melanoma Res 2004;14(5):403-407.

3. Soyer H, Argenziano G, Zalaudek I, Corona R, Sera F, Talamini R, et al. Three-point checklist of dermoscopy. A new screening method for early detection of melanoma. Dermatology. 2004;208:27-31.

4. Stanganelli I, Serafini M, Bucch L. A cancer-registry-assisted evaluation of the accuracy of digital epiluminescence microscopy associated with clinical examination of pigmented skin lesions. Dermatology. 2000;200(1):11-16.

5. Dinnes J, Deeks JJ, Grainge MJ, et al. Visual inspection for diagnosing cutaneous melanoma in adults. Cochrane Database of Systematic Reviews. 2018;12:CD013194.

6. Data on File, DermaSensor Inc.

7. Seiverling EV, Agresta T, Cyr P, Caines L, Nguyen VL, Chatha K, Siegel DM. Clinical Utility of an Elastic Scattering Spectroscopy Device in Assisting Primary Care Physician’s Detection of Skin Cancers. Poster Presentation, Maui Derm Hawaii Conference, Wailea, HI, January 24-28, 2023.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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