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In this episode, Ayesha talked about the FDA clearance of a new at-home sleep apnea test developed by Belgium-based scale-up Sunrise. The wireless, AI-powered device is placed on a user’s chin, making it non-invasive and easy to use. The test has been clinically validated against traditional polysomnography testing and can help provide an accurate sleep apnea diagnosis. Hear more about the device in this episode.
Ayesha also talked about the teaming up of basketball legend Kareem Abdul-Jabbar and the Bristol Myers Squibb/Pfizer Alliance for a new ad campaign to help raise awareness about atrial fibrillation (AFib). The basketball Hall of Famer was diagnosed with the condition and in a video for the campaign, he describes how he initially dismissed his symptoms. He encourages others to learn from his experience and seek medical attention as soon as any symptoms appear. February is also American Heart Month, which is marked every year to help promote awareness about cardiovascular health.
Read the full articles here:
Sunrise’s At-Home Sleep Apnea Test Gets FDA Clearance
‘No Time to Wait’ Ad Campaign from BMS-Pfizer Features Basketball Legend Kareem Abdul-Jabbar for AFib Awareness
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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Bastiaan Driehuys, Founder and Chief Technology Officer at Polarean Imaging.
Polarean is a medical imaging company focused on improving the state of lung imaging. The company recently received FDA approval for its drug device combination product, Xenoview. Xenoview is a hyperpolarized contrast agent, prepared from the Xenon 129 Gas Blend, that is indicated for use with MRI to evaluate lung ventilation in adults and pediatric patients 12 years of age and older.
Tune into the episode to learn more about the FDA approval of Xenoview, including the journey to its approval. Hear about Dr. Driehuys’ extensive research career developing hyperpolarized Xenon 129 as an MRI contrast agent and how that led him to co-found Polarean with the goal of improving the state of lung imaging.
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Ayesha talked about the launch of Amgen’s Amjevita, the first Humira biosimilar to hit the market. Amjevita received FDA approval in 2016 and after a legal settlement with Humira maker AbbVie, has finally reached market launch. AbbVie has been embroiled in legal battles over accusations of overpatenting and price hiking to block Humira biosimilar competition. Hear more about Amjevita and how 2023 is a big year for Humira biosimilars with over half a dozen more launching this year.
Ayesha also discussed new Alzheimer’s research from Kings College London that could lead to the development of a blood test for the early detection of the disease. The research found that certain biomarkers in the blood of patients with mild cognitive impairment (MCI), which some Alzheimer’s patients develop before being diagnosed with the disease, could predict the onset of Alzheimer’s up to 3.5 years before a clinical diagnosis is made. Learn more about the new research in this episode.
Read the full articles here:
Amgen’s Amjevita Enters Market as First Humira Biosimilar, But at Two Different Price Points
Early Detection of Alzheimer’s Disease: New Research Shows How a Blood Test Could Lead to Earlier Diagnosis
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Susan Benton, Country Manager at Thea Pharma, an eye care company that focuses on developing innovative eye care treatments to help further the future of ophthalmic treatment.
Thea Pharma recently won FDA approval for its latest eye care product Iyuzeh for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Iyuzeh is the first and only preservative-free formulation of the medication latanoprost in the US.
To talk more about the new FDA approval for Iyuzeh and about the great work being done at Thea Pharma, tune in to hear this informative and insightful interview with Susan Benton, who has more than 25 years of global commercial and business development experience in ophthalmic pharmaceuticals, and has been responsible for the launch and commercialization of more than 15 products over the course of her career.
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this week’s episode, Ayesha discussed the new Omicron subvariant XBB.1.5, also known as Kraken, which is rapidly circulating in parts of the US. It is the most transmissible variant yet and is highly immune evasive. COVID-19 cases have been on the rise in the country, including significant increases in hospitalizations and deaths. While XBB.1.5 has been found in dozens of other countries now, cases remain low around the world. Hear more about the new subvariant and why scientists are keeping a close eye on it.
Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. The inhaler is approved as a rescue medication for adults with asthma to help treat bronchoconstriction and asthma attacks. It’s the first inhaler that both treats symptoms and the underlying causes of an attack by targeting inflammation of the airways.
Read the full articles here:
XBB.1.5 Omicron Subvariant Being Closely Watched as Most Transmissible Variant Yet
AstraZeneca’s Airsupra Approved as First-In-Class Combo Asthma Treatment
For more life science and medical device content, visit the Xtalks Vitals homepage.
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Twitter: @Xtalks
In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Monique Gary, or Dr. Mo, a breast surgical oncologist, researcher, advocate and expert on cancer and healthcare disparities.
Dr. Mo is passionate about developing integrative, holistic and innovative approaches to cancer treatment, prevention and survivorship both locally and throughout the world. She serves on the board of several community organizations and was recognized as a Leading Physicians of the World and Top Breast Surgeon in Pennsylvania for 2017, 2018 and 2019.
On the show, Dr. Mo spoke about disparities in breast cancer treatment and care. particularly among minorities, including Black women. She shared ways in which patients can advocate for themselves; discussed some of the advancements in breast cancer screening and prevention; improving clinical trial participation; and the importance of strengthening relationships and communication between patient and physician communities. Hear the informative and insightful conversation in this episode.
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this episode, Ayesha talked about some of the trends to look out for in the life sciences in 2023. With a handful of significant gene therapy approvals in 2022, the cell and gene therapy space continues to rapidly expand, and hence we can expect more ground-breaking gene therapy approvals in the coming year, particularly for rare diseases. As our world becomes increasingly digitized, this includes greater implementation of digital health in healthcare. What are the roadblocks and potential burdens of digital health, and can healthcare go completely digital? Also hear about the issue of drug shortages and how pharma companies hope to tackle it in 2023.
Read the full article here:
4 Life Sciences Trends for 2023
For more life science and medical device content, visit the Xtalks Vitals homepage.
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In this week’s Xtalks Life Science podcast episode, Ayesha and the team spoke with the co-founders and co-CEOs of Amylyx, Joshua Cohen and Justin Klee, and Amylyx’s General Manager of Canada Chris Aiello.
Amylyx is a pharmaceutical company focused on the development of therapies for neurodegenerative diseases. On September 29th this year, Amylyx received FDA approval for its oral, fixed dose medication Relyvrio for the treatment of adults with amyotrophic lateral sclerosis (ALS). A few months earlier, the medication had received conditional approval in Canada, where it is marketed under the brand name Albrioza. To hear more about Relyvrio’s approval, including how the Ice Bucket Challenge for ALS helped in the drug’s development, and Amylyx’s continuing work in neurodegenerative diseases, tune into the episode.
Read more at:
Relyvrio Approved as ALS Treatment by the FDA
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 Ferring Pharmaceuticals’ fecal matter-based therapy Rebyota for the treatment of recurrent C. difficile infections. While fecal matter transplants (FMT) have been a standard of care for recurrent CDIs, despite not having formal approval, Rebyota has become the first FDA approved FMT-based treatment for CDIs. Hear more about the drug and its approval in this episode.
Ayesha also discussed a new CBD oral capsule being developed by PureTech Health for the treatment of epilepsy and potentially other indications as well. The drug will be going up against Jazz Pharma’s Epidiolex, which was first approved in 2018 for the treatment of seizures associated with rare types of epilepsy. Hear about the advantages of an oral capsule formulation of CBD, including lower costs and not requiring the use of sesame oil.
Read the full articles here:
FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection
PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex
For more life science and medical device content, visit the Xtalks Vitals homepage.
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