Xtalks Life Science Podcast

In this episode, Ayesha shared news about the FDA approval of the first gene therapy for the rare blood disorder Hemophilia B. The approval was awarded to CSL Behring’s Hemgenix, a single-dose gene therapy that delivers a working copy of the gene that codes for the Factor IX protein that is deficient, or made in insufficient amounts, in patients with Hemophilia B. The therapy is now officially the world’s most expensive drug at $3.5 million per dose. Hear more about the therapy and how the high price tag of the new drug is actually lower than the cost of treating Hemophilia B patients over their lifetimes with current conventional treatment.

Ayesha also talked about World Antimicrobial Resistance (AMR) Awareness Week, which is led by the World Health Organization (WHO) to improve awareness and take measures to combat the global health threat of AMR. The theme of this year’s awareness week was “Preventing AMR Together,” highlighting the need for multi-disciplinary and collective action against AMR. Ayesha spoke to experts from bioMérieux Canada and One Health to learn more about the global efforts against AMR and shared their insights in this episode.

Read the full articles here:

Hemgenix Approved as First Gene Therapy for Hemophilia B

World Antimicrobial Resistance (AMR) Awareness Week: Preventing AMR Together

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha talked about the breakthrough FDA approval of Provention Bio’s Tzield for delaying the onset of type 1 diabetes in adult and pediatric patients. It’s the first approved treatment for slowing the progression of stage 2 type 1 diabetes to stage 3, the stage at which a clinical diagnosis is made. Tzield is an immunotherapy that was in development for over three decades. Find out more about the drug and how it may be a gamechanger for type 1 diabetes.

Ayesha also talked about the latest positive Phase III trial data that Pfizer recently shared for its maternal RSV vaccine candidate. The data showed that the vaccine led to a significant reduction in the rate of severe medically attended lower respiratory tract illness (MA-LRTI) in newborns, a complication that can result from respiratory syncytial virus (RSV) infection. Hear more about the vaccine trial data, based on which an independent data monitoring committee has recommended that Pfizer file with the FDA for approval.

Read the full articles here:

Tzield Gets FDA Nod to Become First Approved Drug to Delay Onset of Type 1 Diabetes

Pfizer Shares Positive Phase III Data for Maternal RSV Vaccine Candidate

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha discussed Novo Nordisk’s Ozempic (semaglutide) shortage, largely attributed to off-label prescribing for weight loss and viral TikTok videos. The GLP-1 agonist is indicated as a type 2 diabetes treatment but has weight loss as a side effect. The shortage could give competitor Eli Lilly’s new dual GIP/GLP-1 agonist Mounjaro added market advantage, but can the company meet the unprecedented demand?

Ayesha also talked about Eli Lilly falling victim to a fake Twitter account that tweeted the company was offering free insulin. The fraudulent account has a blue check, which users can purchase through a $8 per month subscription for the revamped Twitter Blue program introduced by Elon Musk. Lilly clarified the fake message, but the tweet has re-ignited debate about the cost of insulin in the US.

Read the full articles here:

Novo Nordisk’s Ozempic Shortage Spurs Demand for Eli Lilly’s Diabetes Injection Mounjaro

Fraudulent Eli Lilly Twitter Account Announces Free Insulin

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha and the editorial team spoke with Peter Sallstig, MD, MBA, Global Head of Product Development Division and Chief Medical Officer (CMO) at Santen Pharmaceuticals, a biotech company focused on leveraging key, innovative technologies to develop solutions for eye-related problems worldwide. Recently, Santen received FDA approval for the company’s OMLONTI eye drops for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. In this interview, Dr. Sallstig spoke about OMLONTI, what makes his work and team at Santen so special and the company’s commitment to innovations in eye health. 

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha discussed the FDA approval of two new immunotherapies, including Janssen/Johnson & Johnson’s bispecific antibody Tecvayli for the treatment of relapsed or refractory multiple myeloma. The drug is the first bispecific T cell antibody to be approved in the US. It is indicated as a fifth line treatment for multiple myeloma patients who have received four or more prior treatments. Find out more about the bispecific antibody and about trials evaluating it in combination with other drugs to potentially move up its treatment line.

Ayesha also talked about the FDA approval of AstraZeneca’s immunotherapy Imjudo for hepatocellular carcinoma (HCC), which is the most common type of liver cancer. The drug is indicated for use in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi in adult patients with unresectable HCC. The new drug combination will be going up against Roche’s combo of Tecentriq and Avastin, which recently became the standard of care for HCC. Despite this, the Imjudo and Imfinzi approval offers another promising treatment option for HCC patients and is the first dual immunotherapy treatment regimen for this indication.

Read the full articles here:

Multiple Myeloma Drug Tecvayli Becomes First FDA-Approved Bispecific T Cell Antibody

AstraZeneca’s Immunotherapy Imjudo (tremelimumab) Wins FDA Approval for Liver Cancer

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha and the editorial team spoke with prominent cystic fibrosis and rare disease patient leader Gunnar Esiason to learn more about his advocacy work, including his work in clinical trials and developing patient-facing technologies. Gunnar has consulted on clinical trial development, a real-world evidence population health study and a cystic fibrosis-specific mental health and wellness screening tool. He has been the face of fundraising efforts for the Boomer Esiason Foundation, which has raised more than $160 million for the fight against cystic fibrosis since he was diagnosed with the condition in 1993. He also has a successful blog and has co-hosted and hosted podcasts, with his most recent one called The State of Health with Gunnar Esiason, which has featured sitting US senators, governors and health industry leaders. Hear more about Gunnar’s work and his passion for patient advocacy and improving rare disease clinical research in this episode of the Xtalks Life Science podcast.

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha discussed Elon Musk’s recent revelation that in addition to fasting, he also used Novo Nordisk’s weight loss drug Wegovy to help him get “lean and fit.” In response to a question on Twitter, Musk disclosed that both fasting and Wegovy were his secrets to his recent weight loss. Musk is not affiliated with Novo so his endorsement of the drug came as a surprise, and is also problematic according to some. Hear more about the story in this episode.

The editorial team also learned about the FDA approval of Nevro Corp’s AI-based spinal cord stimulation (SCS) system for the treatment of chronic pain. Nevro says its Senza HFX iQ system is the first and only AI-based SCS system that personalizes care by “learning from patients.” The implantable device delivers neurostimulation via the company’s proprietary high frequency pulse technology that has been evaluated in more than 90,000 patients. 

Read the full articles here:

Elon Musk Reveals Weight Loss Injection Wegovy Helped Him Get Lean and Fit

Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha and the editorial team spoke with Caroline Hamilton, Clinical Director of Neuromod Devices, a medical technology company that specializes in the design and development of neuromodulation technologies. The company is committed to addressing the clinical needs of underserved patient populations who live with chronic and debilitating conditions globally. Caroline spoke to Xtalks about Neuromod’s proprietary, patented bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of Neuromod's technology is the Lenire device for the treatment of tinnitus, frequently referred to as “ringing in the ears.” Tinnitus is believed to impact between 10 to 15 percent of adults worldwide. Hear more about Neuromod’s Lenire device, including clinical and real-world data showing its effectiveness in improving symptoms of tinnitus.

In this episode, Ayesha and the editorial team spoke with Pierre Bertrand, CEO of vision care biotech Neurolens, developer of innovative new technology to address digital vision syndrome. The syndrome is caused by extended computer or digital device use that can result in eyestrain as well as neck and shoulder pain. Hear more about the company’s Neurolenses, which are designed to alleviate and even prevent symptoms of digital vision syndrome. Learn about the proprietary technology behind Neurolenses and recent results from clinical studies that show its effectiveness in improving eye function and comfort.

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

Follow Us on Social Media

Twitter: @Xtalks

In this episode, Ayesha discussed the FDA approval of bluebird bio’s Skysona for slowing the progression of neurologic dysfunction associated with the rare neurological disorder cerebral adrenoleukodystrophy (CALD) in boys four to 17 years of age with early, active CALD. The one-time administered gene therapy has also taken the title of being the world’s most expensive drug at $3 million. Hear more about the treatment and how the high prices of gene therapies can be alarming, but reimbursement programs are designed to pick up the costs.

Ayesha also talked about the emergence of a new COVID-19 variant called BF.7 that the CDC is closely watching. The new strain of the coronavirus is a subvariant of the BA.5 Omicron variant. It appears to be more transmissible than other variants and subvariants and its incidence has doubled in just two weeks according to the latest CDC data. Find out more about BF.7 including how it could drive the new anticipated wave of COVID infections this fall.

Read the full articles here:

Bluebird Bio’s Skysona Receives FDA Approval and Becomes World’s Most Expensive Drug

CDC Expresses Concern Over New COVID-19 Variant BF.7

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

Follow Us on Social Media

Twitter: @Xtalks