| Today’s Big NewsSep 11, 2023 |
| By Fraiser Kansteiner The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. |
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By Annalee Armstrong Moderna is doubling down in cancer vaccines and cell therapies with a new Immatics research partnership that could eventually top $1.7 billion in milestones. |
By Andrea Park Patients who underwent Theranos’ fraudulent blood tests at the startup’s dozens of outposts in Walgreens stores are finally getting refunds from the drugstore chain. |
By James Waldron Roche has installed “stronger gates” to ensure that drug candidates only make it into phase 3 trials if they have a high chance of success, CEO Thomas Schinecker has revealed. |
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Thursday, September 21, 2023 | 2pm ET / 11am PT In today's ever-evolving healthcare landscape, understanding and leveraging data to develop comprehensive insights is crucial to stay ahead. Specialty datasets, such as genomics, clinical, labs, and patient hub data, are critical to unlock deeper insights and improve healthcare data utilization, and it’s important to ensure these various sources of data seamlessly integrate. Register now to learn more. 
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By Kevin Dunleavy Supernus is sharing positive results for its nonstimulant ADHD treatment, Qelbree, which was approved for children in 2021. In a poster presented over the weekend at Psych Congress 2023, Qelbree was shown to sharpen the focus of children 6 and older when combined with a stimulant. The drug also showed efficacy in adult patients when used over a long period of time. |
By Gabrielle Masson Vigil Neuroscience has been granted clearance from the FDA to launch an early-stage Alzheimer’s trial, but that approval comes with strings attached: a partial clinical hold. |
By Angus Liu The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR). |
By Andrea Park The FDA has cleared a handful of AR-based technologies that add virtual overlays to a surgeon’s view, highlighting target areas and providing helpful calculations and other analytics on the side. |
By Annalee Armstrong Neumora and RayzeBio are both casting a line into the market, with each seeking to raise more than $200 million in initial public offerings this fall. |
By Gabrielle Masson Madrigal Pharmaceuticals’ CEO Paul Friedman, M.D., is stepping aside so Sanofi’s Bill Sibold can take the reins ahead of a possible FDA greenlight for what would be the first treatment approved for nonalcoholic steatohepatitis (NASH). |
By Zoey Becker The blockbuster inflammatory med's patents begin to expire this year, leaving biosimilar makers scrambling for a piece of the large market. Versions from Amgen, Teva and Alvotech are expected to launch in early 2025. |
By Conor Hale S4 Medical’s solution is the Esolution, a vacuum-powered catheter first developed at The Ohio State University, which curves the esophagus to move it away from the heat generated during cardiac ablation procedures. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage |
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Wednesday, September 27, 2023 | 11am ET / 8am PTIn the rapidly evolving field of drug discovery, where the COVID-19 pandemic has further accelerated changes in working patterns, the importance of efficient teamwork, open communication, and streamlined processes throughout the Design-Make-Test-Analyze (DMTA) cycle is essential. Technology holds the potential to address these challenges by improving collaboration. Register now to learn more. 
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