| Today’s Big NewsSep 13, 2023 |
| By Max Bayer Moderna CEO Stéphane Bancel is optimistic that the company will beat the low end of its $6 billion to $8 billion COVID vaccine sales estimate for 2023. But his optimism comes as Moderna reportedly eyes manufacturing cuts as it shifts to an endemic market response. |
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By Max Bayer After tweaking the formula behind an mRNA flu vaccine, Moderna has finally met all the goals needed for a successful shot in a phase 3 trial. Now, CEO Stéphane Bancel is eyeing a launch as early as 2024. |
By Fraiser Kansteiner Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing. |
By Conor Hale Insight Medbotics' breast biopsy robot has secured an FDA clearance for what the company describes as the world’s first to operate within the bore of an MRI machine. |
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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 Gabrielle Masson Just days after a CEO shake-up, Madrigal Pharmaceuticals has shared that the FDA has given its NASH drug priority review and that the agency doesn’t plan on holding an advisory committee meeting. |
By Andrea Park After undergoing treatment with IB-Stim’s percutaneous electrical nerve field stimulation therapy once a week for four weeks, patients reported “significant reductions” from their baseline scores of abdominal pain, nausea severity and functional disability—improvements backed by their parents’ own surveys, too. |
By Annalee Armstrong Eiger BioPharmaceuticals is finally putting a pin in efforts to find a home for peginterferon lambda, a drug once tried in COVID-19 that has now failed in a study for chronic hepatitis delta. |
By Zoey Becker While it scales up manufacturing, the company is rolling out its Adstiladrin through an early, focused program at certain clinics. The program will also be used for a real world evidence study. |
By Andrea Park Less than two years after emerging from stealth, Zeta has earned FDA clearance for its digital navigation system that helps surgeons carry out precise brain surgery 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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