| 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. |
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For researchers unaffiliated with an academic library, finding scientific papers can be time-consuming and expensive—and organizing or sharing them can be even harder. Can a new tool address this gap? Learn more. 
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Today's Big NewsDec 7, 2022 |
| By Annalee Armstrong Pfizer is rushing to get its RSV vaccine out the door and into arms. A priority review from the FDA will certainly help. |
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By Annalee Armstrong It’s been a year since Avrobio suffered a blow to its gene therapy ambitions with the failure of a Fabry disease program. Now, the biotech is ready to reintroduce itself to investors with a small positive dataset for its new No. 1 priority and the go-ahead from the FDA to advance the clinical program in a rare disease. |
By Nick Paul Taylor Neurocrine Biosciences’ $45 million rare pediatric epilepsy bet has fallen at an early clinical hurdle. Thirty months after licensing the selective T-type calcium channel inhibitor, the biotech has reported its second setback in quick succession with the failure to beat placebo in a small phase 2 clinical trial. |
By Gabrielle Masson MorphoSys is trimming its pipeline a bit, pulling in $23 million cash from Novartis in exchange for worldwide licensing rights to its preclinical cancer program. |
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In addition to their standard consultative approach to CRO studies, XenoTech also provides gap analysis, interpretation and advice, submission or publication assistance, and other consulting... Read More >> 
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By Gabrielle Masson On the heels of a failed phase 2/3 study, Lysogene has suspended trading of its shares and is seeking potential partnerships and investors in an effort to stay afloat. |
By Nick Paul Taylor Prometheus Biosciences has laid down a major marker in the anti-TL1A space. Days after Pfizer offloaded its rival candidate to Roivant, Prometheus has reported midphase data in ulcerative colitis and Crohn’s disease that sent its stock up 170% in premarket trading. |
By Gabrielle Masson Paragon Therapeutics has launched its first spinout, dubbed Apogee Therapeutics. The California company already touts a sizable $169 million to advance at least four of Paragon’s preclinical pipeline candidates designed to treat inflammatory and immunological disorders. |
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 Joseph Keenan Trial tech firm Medidata launched a new app designed to give patients participating in remote clinical trials an easier experience. |
By Angus Liu GSK's emerging oncology business just got a much-needed boost after several recent setbacks. A first glimpse at its PD-1 inhibitor's head-to-head data against Keytruda looks encouraging. |
By Robert King A new report estimates 18 million people could lose Medicaid coverage due to eligibility redeterminations, but most will be able to transition to other coverage sources. |
By Ben Adams Johnson & Johnson is now in its third century of supporting nurses and this month, after nearly three years of increasing pressure on the profession amid the COVID-19 pandemic, the U.S. Big Pharma is driving home the message: “Where would we be without nurses?” |
By Andrea Park After months of lead-up, Carla Kriwet, Ph.D., spent only a few weeks at the helm of Fresenius Medical Care. |
By Kevin Dunleavy On ICER’s annual list of drugs that had unjustified price increases in 2021, Bausch’s Xifaxan and Johnson & Johnson’s Invega Sustenna caused the most additional spending in the U.S. The treatments displaced Humira as the top offender in 2020. |
By Robert King CMS issued a proposal rule to implement electronic prior authorization by 2026 for Medicare Advantage, ACA and Medicaid managed care plans, replacing a 2020 rule that was withdrawn. |
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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Thursday, December 15, 2022 | 11am ET / 8am PT Cell therapy products have amazing potential to treat a wide variety of diseases and vast numbers of patients globally. In this webinar we discuss what these key challenges are, how to approach these challenges and some opportunities available to better the process. 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 |
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 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 |
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 |
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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