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Today's Big NewsFeb 27, 2023 |
| 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. |
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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. |
By Nick Paul Taylor CSL is coming for one of Takeda’s fastest-growing products. Phase 3 data on CSL’s garadacimab in a rare disease suggest the monoclonal antibody may have an edge over Takeda’s Takhzyro in terms of efficacy and convenience, giving the biotech a boost as it races to file global regulatory submissions this year. |
Sponsored by North Carolina Biotechnology Center Growth in North Carolina’s life sciences has outpaced most U.S. life sciences hubs. Top talent, infrastructure, and business-friendly climate are why companies are choosing the Tar Heel state. |
By James Waldron Where did it all go wrong for Apexigen? Seven months after going public via a SPAC merger, the Epitomics spinout is already culling half its workforce and looking for a potential buyer or other escape route. |
By Nick Paul Taylor Biocytogen Pharmaceuticals has found a partner for its push to develop a better checkpoint inhibitor, with Chipscreen NewWay Biosciences picking up regional rights to its PD-1xCD40 bispecific antibody. |
By Helen Floersh Bioengineers have used cardiovascular data from individual patients to print soft models of their hearts, complete with the ability to pump just as their hearts did with the help of a robotic sleeve. Their work could be used to help clinicians pick the best-fitting TAVR implant and reduce the likelihood of complications. |
By Ben Adams Sanofi and the Brand Institute have raised the bar in drug naming with the audacious use of not one, not two, but three of the same letter in a row for its new hemophilia treatment. |
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 Angus Liu Drug reviewers at the European Medicines Agency have recommended an approval for the combination of Zejula and Zytiga for metastatic castration-resistant prostate cancer. But only patients with BRCA1/2-mutated tumors will be eligible for the fixed-dose combo. |
By Zoey Becker It's the end of a rocky road for Akorn. After years of financial problems, the drugmaker has laid off all of its employees, according to reports. |
Fierce podcasts Don'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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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 |
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Whitepaper For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
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Whitepaper How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
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 |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. 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 |
| May 1-3, 2023 | Jersey City, NJ |
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