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GeneSuites is the development manager for Catalyst BioCampus in North Carolina which is on track to support biomanufacturing by 2024. Learn more. 
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Today's Big NewsDec 2, 2022 |
| By Fraiser Kansteiner Friday, Pfizer said it would plug 1.2 billion euros into its manufacturing site in Puurs, Belgium, just one day after plotting an identical outlay in Dublin, Ireland. In Belgium, where the expansion will occur over the next three years, some projects have already been started, while others are scheduled to begin in early 2023, Pfizer said in a local press release. |
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By Andrea Park Medtronic’s HeartWare Ventricular Assist Device may be off the market, but it’s still very much on the company’s mind. |
By Nick Paul Taylor Mirati Therapeutics is going to have to wait a bit longer to learn if sitravatinib works. Having touted an interim phase 3 review as an event that could support full approval, the biotech has learned that the lung cancer study will continue to its final analysis. |
By Paige Minemyer A panel of judges in Florida ruled this week that UnitedHealthcare must pay TeamHealth $10.8 million for underpayments, the latest round in the companies' ongoing legal bout. |
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Tuesday, December 6, 2022 | 12pm ET/9am PT Biopharma customers are now demanding that the vendor industry work collaboratively to connect their scientific workflows. This webinar will provide valuable insights for biopharmaceutical scientists, lab directors, IT professionals, and life science vendors. Register now. 
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By Zoey Becker As GSK races to match its PD-1 blocking antibody Jemperli to Merck’s superstar Keytruda, new pivotal data could help it convert an accelerated approval and expand into a broader endometrial cancer population. |
By Andrea Park Several models of BD’s BodyGuard infusion pumps face a moderate risk of being hacked, the company reported this week. |
By Nick Paul Taylor The FDA has killed off Y-mAbs Therapeutics’ slim hopes of winning approval for 131I-omburtamab at the first time of asking. Weeks after its advisory committee roundly rejected the candidate, the agency has hit YmAbs with a complete response letter and discussed the need for an adequate and well-controlled trial of the rare pediatric cancer drug. |
By Robert King The Senate Finance Committee released a discussion draft outlining new ways to improve mental health pay parity as part of a larger package. |
By Kevin Dunleavy More than two months ahead of its PDUFA date, Rigel Pharmaceuticals has won approval for Rezlidhia. The endorsement is for adults with relapsed or refractory acute myeloid leukemia (AML) with a specific genetic mutation—isocitrate dehydrogenase-1 (IDH1)—as detected by Abbott’s Real Time IDH1 diagnostic tool. |
By Conor Hale The upcoming OmnifyXR system will be designed to provide a heads-up display of interventional X-ray imaging using Microsoft’s HoloLens hardware. |
By James Waldron Four months after the FDA slapped a clinical hold on Beam Therapeutics’ phase 1 ready off-the-shelf CAR-T, the biotech is now free to proceed. |
By Heather Landi Despite the market downturn and economic pressures, the majority of investors expect digital health dollars in 2023 to be roughly on par with 2020, bringing in an estimated $15 billion to $25 billion. |
By Fraiser Kansteiner In a late November court decision unsealed Wednesday, the U.S. Court of Federal Claims sided with Gilead’s argument that the U.S. Centers for Disease Control and Prevention broke certain agreements with the company around its HIV drug for preexposure prophylaxis. The win could bode well for a separate patent case where the U.S. government is seeking more than $1 billion in damages from Gilead. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition. |
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Tuesday, December 7th, 2022 | 10am ET/7am PT In this presentation we’ll review how we established GOCHO™ cells from an adherent CHO-K1 cell line to meet current industry standards, how the choice of cloning media drove cell culture media choices for the entire cell-line development process, and more. Register now. 
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Video Revolutionize your monoclonal antibody (mAb) manufacturing with expert insights. Sponsored by: Gibco |
Whitepaper Learn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific. Sponsored by: Thermo Fisher Scientific |
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Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
Whitepaper This paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success. Sponsored by: Blue Matter |
Executive Summary Strategies to help scale-up for commercial manufacturing are critical to getting cell and gene therapies to patients as more advanced therapies reach late-stage clinical studies and regulatory decisions. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics |
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 |
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