| Editor's note: Getting ready for #ASH22? Fierce Pharma will talk to Dr. Naveen Pemmaraju at MD Anderson in a Twitter chat about the latest advances in blood cancer. Search #FierceTalksASH starting at 4pm ET on Dec. 8 to join the conversation. Our team will also be on site in New Orleans to bring you fresh data from the annual conference. |
Today's Big NewsDec 6, 2022 |
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Thursday, December 15, 2022 | 11am ET/8am PT Join Aaron Miri and Amy Huveldt from Baptist Health, Jacksonville to learn how they are scaling disruptive, AI-based technology across the enterprise. During this webinar, Aaron and Amy will share best practices of a successful digital transformation as well as the results they have experienced system-wide. Register Now. 
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| By Andrea Park Months after Neuralink shot down allegations of “horrific abuse” in its animal testing practices, the U.S. Department of Agriculture’s inspector general has reportedly opened an investigation into the accusations against Elon Musk’s brain-computer interface company. |
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By Angus Liu In a potential key battleground for KRAS inhibitors that involves combination with Merck's PD-1 king Keytruda, Mirati's adagrasib appears to be pulling ahead of Amgen’s first-to-market Lumakras in the latest clinical data revelation. But Mirati's stock price still tanked. |
By Fraiser Kansteiner In the latest legal entanglement, Teva is accused of stalling the rollout of its generic EpiPen in a quid pro quo with the epinephrine injector’s owner, Viatris. In return for the epinephrine launch delay, Viatris promised not to undercut Teva’s branded narcolepsy med Nuvigil with its own generic, according to court documents filed earlier this month. |
By Frank Diamond Hospitalizations for influenza almost doubled in the week after the Thanksgiving holiday. Have mitigation efforts against COVID-19 left us immunologically naïve? |
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Thursday, December 15, 2022 |2:00pm ET / 11:00am PT This talk emphasizes the role of partnerships between early- and late-stream analytical assay developers while tackling unique challenges in validating flow cytometric methods for Chimeric Antigen Receptor (CAR) T cells, during manufacturing and clinical monitoring. We will be introducing Critical Quality Attributes and key considerations when designing sample preparation methods, optimization, validation, and implementation for cell and gene therapy bioanalytics. Register now. 
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By Andrea Park Roche’s decision earlier this year to pluck a new chief executive from the top of its diagnostics pyramid has triggered a domino effect of promotions and replacements, all slated to take effect early next year. |
By Nick Paul Taylor The dominoes keep falling in the PI3K space. After meeting with the FDA, Kyowa Kirin and MEI Pharma have stopped development of their B-cell malignancy prospect zandelisib outside of Japan. |
By Angus Liu When Eli Lilly’s Verzenio snagged an FDA go-ahead to treat certain breast cancer patients after surgery, the first-in-class nod was weakened by an unexpected limitation. Now, the company hopes longer-term follow-up data will convince U.S. regulators to remove the restriction. |
By Conor Hale BioCardia received the go-ahead from the FDA for a first-in-human trial of a second version of its stem cell implants designed to help rescue patients from heart failure. |
By Max Bayer Summit Therapeutics is betting up to $5 billion for rights to Akeso's bispecific antibody, one of the largest licensing deals in recent memory. Summit says it plans to start treating lunch cancer patients in clinical trials by the second quarter of 2023. |
By Robert King A new analysis finds three of the largest for-profit hospital chains have operating margins that exceeded pre-pandemic levels, as industry groups press for more financial relief from Congress. |
By Fraiser Kansteiner Emergent’s bid is the first switch from prescription to an over-the-counter application to receive the speedy review tag, the company pointed out in a release. If approved, the company’s product would become the first 4mg naloxone nasal spray available without a doctor’s note in the U.S. |
By Gabrielle Masson AbbVie has formed a connection with HotSpot, inking a global licensing option deal for the biotech’s preclinical small-molecule allosteric therapy and extending the opportunity to make up to $295 million in biobucks. |
By Paige Minemyer Another major pharmacy benefit manager is adding Humira biosimilars to its formulary beginning next year. |
By Joseph Keenan Global pharma giants GSK, Sanofi and Takeda signed on with with a partnership of agencies to advance biologic manufacturing in Singapore. |
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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This playbook looks at why insolubility is an issue, and the properties that affect solubility, such as the molecule’s structure; its physical attributes (particle size and dissolution rate); its chemical attributes, including compatibility with excipients; and its biological properties. Download 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 |
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 |
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 |
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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