| Today’s Big NewsSep 15, 2023 |
| By Fraiser Kansteiner With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of weighty patent losses. |
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By James Waldron Anyone wanting to end the week on a hopeful note could do worse than to check out the duo of biotech IPOs that made it over the line. RayzeBio has just revealed it overshot expectations by raising $311 million, while Neumora Therapeutics was squarely on target with a $250 million offering. |
By Conor Hale The Mayo Clinic is expanding its decade-plus ties with GE HealthCare, with a slate of new joint R&D projects that will explore the use of digital imaging and theranostics—with the goal of advancing the clinic’s research closer to the commercial market. |
By Nick Paul Taylor MAPS Public Benefit Corporation has shown off phase 3 data it hopes will secure a landmark approval for MDMA in the U.S. next year. The second phase 3 success is the result of almost 40 years of work to show that psychedelics can treat post-traumatic stress disorder (PTSD) when used to enhance therapy. |
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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 Zoey Becker The CEO is eying some big changes, but he wants to show investors he's prepared to act swiftly, Reuters reports. The publication cited three people "familiar with the matter" in reporting the behind-the-scenes developments at Bayer. |
By Angus Liu A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review. |
By Andrea Park Beacon Biosignals is living out a dream scenario: Mere weeks after acquiring EEG headset maker Dreem, it has earned FDA clearance for a sleep monitoring solution that combines the Dreem hardware with Beacon’s own artificial intelligence-based software. |
By Nick Paul Taylor The FDA has provided yet another twist in the Iovance Biotherapeutics saga. After years of delays, the biotech was on track to receive an approval decision on its tumor-infiltrating lymphocyte melanoma therapy this year only for the FDA to delay the deadline because of “resource constraints.” |
By Andrea Park The FDA has given separate green lights to two wearable monitors that aim to improve the accuracy of continuous electrocardiography tracking. |
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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