| Today's Big NewsFeb 27, 2023 |
| By Kevin Dunleavy A potential buyout of Seagen by Pfizer—which was reported Sunday by The Wall Street Journal—makes “strategic sense for both parties and the antitrust hurdle appears surmountable,” Berenberg Capital Markets wrote in a note to investors. |
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By Andrea Park Though the FDA has made moves in recent months to begin narrowing the steady stream of emergency use authorizations it’s handed down to COVID-19 tests throughout the pandemic, those waters haven’t yet run completely dry. |
By James Waldron With over 10 indications already being explored and the promise of more to come, it’s no surprise that Johnson & Johnson’s nipocalimab has been dubbed a “pipeline in a product.” It's a good thing, too, because the monoclonal antibody didn't come cheap. |
By Max Bayer Billy Dunn is leaving his post leading the FDA’s neuroscience team, leaving behind an 18-year legacy that in recent years has included the controversial accelerated approval of Biogen’s Alzheimer’s med, Aduhelm. |
By Andrea Park More than 30 years after GE HealthCare first joined forces with Sinopharm, China's state-run drugmaker, the partners are renewing their vows. |
By Eric Sagonowsky Viatris has been working to stabilize its business and deliver revenue growth, and, now, the company selected a CEO to lead its next chapter. Scott Smith, a Celgene veteran, will take the reins in early April. |
By Angus Liu Thanks to cancer drugs Brukinsa and tislelizumab, BeiGene nearly doubled its sales in 2022. But the most important launches for the meds have either just begun or are yet to come. |
By Andrea Park Nearly two years after submitting its MiniMed 780G insulin delivery system to the FDA for clearance, Medtronic is still awaiting the agency’s nod—though not for a lack of evidence to back the technology. |
By Annalee Armstrong What do bats, naked mole rats and Jaws have in common? Probably not a lot, but at least the first two may be able to teach us something about human biology. That’s the hope of a new biotech called Paratus Sciences launching today with $100 million. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinar to hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now.
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| Whitepaper Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success. Sponsored by: Herspiegel Consulting |
| ResearchLike many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
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| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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