| Today's Big NewsFeb 28, 2023 |
| By Annalee Armstrong Both Pfizer and GSK’s upcoming respiratory syncytial virus vaccines had instances of Guillain-Barré syndrome in clinical trials. And yet the FDA is only recommending that one of them conduct a new post-marketing study to assess the risk. |
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By Andrea Park Amid Boston Scientific’s decision to transfer some work out of a facility in Houston in the coming months, more than 100 jobs are hanging in the balance. |
By Kevin Dunleavy Eylea's sales growth is slowing down, Bayer reported on Tuesday, chalking it up to "pricing pressures," while not addressing competition from Roche's Vabysmo. The company expects the trend to continue in 2023 but sees a rebound after a potential high-dose approval. |
By Gabrielle Masson AstraZeneca is bucking the biopharma layoff trend, instead expanding its Canadian footprint with the creation of 500 new jobs and a new rare disease research hub. |
By Angus Liu Novartis has been experiencing challenges meeting the demand for Pluvicto. And as demand climbs, the company has decided to pause accepting new patients until it has “more clarity on the FDA’s approval” of a manufacturing site in New Jersey. |
By Andrea Park Typically, bioprosthetic aortic valves begin deteriorating about a decade after they're implanted—but two of Abbott’s replacement valves may be much less durable than that. |
By Fraiser Kansteiner Between 2026 and 2028, Medicare could parley on pricing for some 38 Part D drugs and 2 Part B drugs under the Inflation Reduction Act. Many well-known pharma brands are among those expected to face negotiations. |
By James Waldron It’s an increasingly common story in 2023—a biotech searching for strategic options after a tough set of clinical data is snapped up by a private company that sees an opportunity in the clinical expertise and Nasdaq listing. |
By Kevin Dunleavy The U.S. Justice Department and the SEC have charged former Phlow Vice President Andrew Stiles with insider training, alleging that he and his cousin, Gray Stiles, netted more than $1.5 million on purchases of stock made using nonpublic information about a government pandemic preparedness contract awarded to Eastman Kodak. |
By Andrea Park Several years into the process of rectifying potential breaches in the sterile packaging of its life support systems—a process that has been littered with field correction notices and FDA-rated recalls—Getinge has been hit with a particularly serious penalty. |
By Ben Adams In Franz Kafka’s 1915 novella "The Metamorphosis," we see the grim reality of a sudden change that turns protagonist Gregor Samsa overnight into a giant, unwieldy insect and the struggles he has from basic movement to the failing empathy from his family and neighbors, who eventually and quite literally throw him away like garbage. |
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| 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 |
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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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