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A manufacturer's handbook for selecting solutions and partners. Learn how to unlock product potential in this step-by-step guide to making the most of your investments at all stages of the commercialization journey. Get the guide. 
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Tuesday, December 6, 2022 | 10am ET / 7am PT The development of therapeutic antibodies has been challenged by the difficulty to generate such intricate molecules. Here, we show that ProBio has established proprietary fast CMC platform guaranteeing the delivery of monoclonal antibody with high titer. Register now. 
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| By Ben Adams Pfizer’s chief executive Albert Bourla is in hot water for claims he made during a BBC interview late last year about his then-unapproved COVID vaccine for younger kids. The claims have been branded “misleading” and “overly promotional," according to a press report. |
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By Annalee Armstrong Two deaths have dimmed the initial glow surrounding Eisai and Biogen’s next Alzheimer’s disease therapy lecanemab. But the Japanese company now has more answers on the risks patients may need to learn to accept to receive treatment. |
By Nick Paul Taylor Concerns are mounting about the safety of Eisai and Biogen’s Alzheimer’s disease prospect lecanemab. Ahead of the presentation of the full phase 3 dataset on Tuesday, Science has reported on the death of a second recipient of the anti-amyloid antibody who suffered a brain hemorrhage. |
By Zoey Becker CSL Behring and uniQure's newly approved hemophilia B gene therapy, Hemgenix, comes with an eye-popping price tag of $3.5 million. The one-time treatment can replace regular prophylactic infusions of factor IX replacement therapy for patients. |
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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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By Andrea Park Nearly a year-and-a-half into Philips’ recall of about 5.5 million of its CPAP and BiPAP machines and other respiratory devices, complaints about the affected machines are still rolling in. |
By Angus Liu GSK is setting a new standard for speed when it comes to withdrawing an accelerated approval after a confirmatory trial failure. The British drugmaker is pulling Blenrep off the U.S. market just 15 days after announcing a phase 3 flop. The move comes despite potentially imminent readouts from two other phase 3 trials. |
By Nick Paul Taylor AstraZeneca is stepping up its pitch for a slice of the cell therapy space, paying $200 million upfront for a solid tumor player that recently hustled an autologous, fully individualized, multispecific prospect into the clinic. |
By Kevin Dunleavy The courtroom drama surrounding Bristol Myers Squibb and its subsidiary Celgene over their efforts to restrict competition for lymphoma drug Revlimid has raged for more than a decade. And it's not going away any time soon, as three union pension funds have brought a class action antitrust suit against Bristol Myers and a raft of generic drugmakers. |
By Kevin Dunleavy Catalent is laying off more than 210 workers at two sites in Maryland and one in Texas according to Worker Adjustment and Retraining Notifications (WARN) posted in the states. The company also is reducing 400 staffers at its sprawling site in Bloomington, Indiana. The layoffs come as the company is cutting costs as revenue from COVID-19 products is in sharp decline. |
By Helen Floersh An mRNA vaccine targeting 20 different subtypes of the flu protected mice and ferrets from severe disease and death, opening a door to a universal flu vaccine. |
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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Monday, December 5, 2022 | 11am ET / 8am PT The data behind the scenes must match and reflect the physical goods moving through the supply chain. In this webinar, we will discuss the four major components of compliance and how to get the data right to let the product flow. Register now. 
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Multimedia Plan Your ASH’22 Attendance In No Time | Interactive Planner Sponsored by: Ferma.AI, a product of ZoomRx |
Video Revolutionize your monoclonal antibody (mAb) manufacturing with expert insights. Sponsored by: Gibco |
Podcast How can Medical Affairs divisions bring greater value to their organizations and practitioners every day? Sponsored by: Medscape Medical Affairs |
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 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 |
Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
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 |
Whitepaper Accelerating bioproduction towards high performance and scale Sponsored by: Capgemini Americas Inc. |
Whitepaper Learn the benefits of unlocking data insights across the healthcare and life sciences ecosystem. Sponsored by: NTT DATA |
Whitepaper Electronic health records (EHR) and patient registries are both important sources of real-world evidence – but which is right for your needs? Sponsored by: Veradigm Health |
Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. 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 |
eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored By: Catalent |
eBook Download now to learn about the benefits of transitioning from intravenous to subcutaneously administration, the advantages of using prefilled syringes, and explore challenges and solutions for transitioning from vials to prefilled syringes. Presented 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 Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
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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