| Zolgensma, the world’s most expensive drug, is causing fresh headaches for Novartis. Before, its $2.1 million sticker price left payers apprehensive about covering the gene therapy. Now, the FDA has revealed manipulated data in its original application—and that Novartis knew of the issue two months prior, but did not notify the agency until one month after it was approved. CEO Vas Narasimhan defended the company’s choice to complete an internal review before alerting regulators, and while the FDA says Zolgensma should stay on the market, it warned it will exercise its full authority, including civil and criminal penalties if needed. | |
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Featured Story | | | Tuesday, August 6, 2019 The FDA is weighing penalties for Novartis over revelations that its application for gene therapy Zolgensma contained manipulated data. |
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| This week's sponsor is ExL Events. | | | |
Top Stories Of The Week Wednesday, August 7, 2019 Novartis faced a fresh scandal this week with revelations AveXis scientists manipulated Zolgensma data. On Wednesday, execs responded with their side of the story. Tuesday, August 6, 2019 GlaxoSmithKline has licensed Ebola vaccines to the Sabin Vaccine Institute. The agreement coincides with the news that Uganda has begun testing a Johnson & Johnson Ebola vaccine. Wednesday, August 7, 2019 Amid a series of change-ups to its top executive team this morning, Eli Lilly has moved its biotech buy’s CEO, Josh Bilenker, into its oncology division, as Levi Garraway hits the exit. Tuesday, August 6, 2019 More than a decade in, Sanofi and Regeneron's antibody partnership has spawned several drugs, but it took Dupixent and its $557 million in Q2 sales to drive the tie-up to its first quarterly profit. Monday, August 5, 2019 Sneaking in the bad news after hours on a Friday (a Bio-Twitter bugbear) still wasn’t under the radar enough to help stop the hemorrhaging of GlycoMimetics’ shares. Tuesday, August 6, 2019 An enduring medical aesthetics franchise, led by wrinkle-fighter Botox, is one of the key reasons AbbVie is shelling out $63 billion for Allergan. That drug has again pulled off a sales jump, though a slower growth rate suggests a tough game ahead. Monday, August 5, 2019 Guardant Health’s blood test could provide an easier way to predict a cancer patient’s response to immunotherapy across multiple types of solid tumors. Friday, August 2, 2019 Fujifilm has sealed the deal. With the completion of an $890 million, all-cash exchange with Biogen, the CDMO is now in possession of a biologics production facility in Denmark with about 800 employees. Wednesday, August 7, 2019 Instead of producing one type of CAR from a patient’s T cells, as is the case with currently available CAR-T treatments for blood cancers, scientists have now designed CAR-T cells with two CAR molecules. The concept is showing promise in tackling HIV. Resources Sponsored by: Patheon, by Thermo Fisher Scientific Patheon, part of Thermo Fisher Scientific, offers advanced API manufacturing technologies such as continuous processing and continuous analytics to deliver high-quality products with well-defined features to meet your timelines and volume requirements. Sponsored by: ICON Understanding the challenges for formulary decision makers and manufacturers. Sponsored by: Veeva This white paper details how leveraging new reporting capabilities, live UAT feedback sessions, and an agile design approach to study builds will save them time and money. Sponsored by: BBK Worldwide The Study Voices survey challenges the myth that physicians won’t refer patients to clinical trials, and it identifies opportunities to engage physicians as partners in the enrollment process. Sponsored by: Cambrex The highest number of NCEs approved by the FDA…the fastest growing small molecule clinical pipeline reported in 20 years…these are exciting times for our industry. Sponsored by: Reprints Desk, Inc. Cut your research time in half - with an easy-to-use app for scientists that combines full-featured reference management with integrated search and on-demand document delivery. Sponsored by: XiltriX North America Find out in this article how your pharmaceutical organization can leverage IoT technologies and informatics integration to innovate and improve overall operational efficiencies. Sponsored by: Catalent Download the case study to learn about the clinical supply management tools that helped a small sized pharma company during phase III of a multi-arm oncology study. Sponsored by: Catalent Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels. Sponsored by: Catalent Download the eBook to explore a proactive approach for clinical supply management. |
