Apellis stops COVID-19 program after missing mortality endpoint NIH stops trial of Brii's COVID-19 antibodies in hospitalized patients for futility Pandion's secret to moving a $65M Merck offer to a $1.9B done deal in a year? Just keep saying no Sponsored: Analysis of Humanized Mice with Myeloid Cell Engraftment Harvard stem cell research lead Jonathan Hoggatt joins Moderna as director of hematology Kronos steps on the gas for genetically defined AML program with new leukemia endpoint From the big screen, to the small screen, to the MRI—Disney teams with Philips to bring its characters to pediatric imaging How roundworms could inspire new treatments for obesity and other food-related diseases Fierce Pharma Asia—AstraZeneca-Junshi PD-1 deal; Takeda's $1.2B diabetes selloff, Ovid epilepsy collab pullout Chutes & Ladders—Genzyme vet Sherblom joins ReForm amid subcutaneous delivery shift Featured Story | By Nick Paul Taylor Apellis Pharmaceuticals has stopped development of APL-9 in severe COVID-19 patients after an interim review of phase 1/2 mortality data. The review found adding the C3 therapy to standard of care had no meaningful effect on mortality, prompting Apellis to pull the plug on the program. read more |
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Top Stories By Nick Paul Taylor The NIH has halted a clinical assessment of two Brii Biosciences antibodies in hospitalized COVID-19 patients for futility. Brii’s BRII-196 and BRII-198 became the latest anti-SARS-CoV-2 antibodies to fail to improve outcomes in hospitalized individuals but remain in development in ambulatory patients. read more By Ben Adams If you want Merck to snap you for nearly $2 billion, all you have to do is play hard ball. read more Sponsored By: Taconic Biosciences Humanized immune system mice are revolutionary tools for the development of oncology therapeutics, but their use has been limited for some applications by impaired human myeloid cell differentiation. read more By Ben Adams Moderna has poached major stem cell researcher Jonathan Hoggatt, Ph.D., to lead its hematology R&D as it gears up for a future outside of COVID vaccines. read more By Amirah Al Idrus Kronos Bio got the FDA sign-off to use a new primary endpoint in a leukemia trial, one that could speed up the development of its drug. In a phase 3 study, Kronos will use highly sensitive sequencing to confirm undetectable levels of leukemic cells in patients— the first time it will be used as a primary endpoint in an AML trial. read more By Conor Hale Getting an MRI has never been a walk in the park. Being fed into a large, almost unnaturally heavy machine powered by unseen forces—and almost always kept in the basement—is understandably unsettling, especially for a child. But it’s something Philips hopes to make a little bit brighter. read more By Angus Liu By studying the simple nematode worm C. elegans, a team led by scientists at the University of Kent discovered a transcription factor that seems to act as a master controller of the sense of hunger and related eating or resting behaviors in humans. The finding could inspire new approaches to treating obesity. read more By Angus Liu AstraZeneca licensed Chinese rights to Junshi Biosciences' PD-1 inhibitor in an oddly structured deal. Takeda transfered Japanese rights to four diabetes meds in a $1.2 billion deal with Teijin Pharma. The Japanese pharma also terminated an epilepsy drug collaboration with Ovid Therapeutics. And more. read more By Fraiser Kansteiner Genzyme's first-ever CFO has joined ReForm Biologics as chair to help lead the company's shift into subcutaneous delivery. Solid Biosciences tapped a new chief legal officer and moved one of its staffers up to COO. Biocon Biologics named a deputy CEO alongside a new chief commercial officer for emerging markets. read more | | Experts in our field with 20+ years’ experience in Viral Vector & Plasmid DNA manufacture. Now part of the Cognate BioServices family, your CDMO partner from concept to commercial for cell & gene therapy products. Request a call back. |
Enrollment Showcase | Sponsored by: University of Florida College of Pharmacy Learn about the Top 5-Ranked UF College of Pharmacy’s online graduate programs in pharmaceutical outcomes & policy. Select from five specializations, including the new pharmaceutical value assessment & communication option. Over half of graduates progress to a new role within one year. Register now. |
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Resources Sponsored by: AmerisourceBergen Unlock product potential by making the most of your commercialization investments. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: Acorn AI Unlock competitive advantage with AI and advanced analytics. Sponsored By: EVERSANA Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How. Sponsored By: BC Platforms Download our whitepaper to learn how BC Platforms has leveraged our technical expertise to offer robust and comprehensive solutions to maximize RWD ROI. Sponsored By: Thermo Fisher Scientific Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain. Sponsored By: Blue Matter, strategic consultants in the life sciences A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones. Sponsored by: Baxter BioPharma Solutions While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. BD&L Summit for Life Sciences March 9–10, 2021 | Virtual Event Learn what it takes to get a drug developed and approved March 9-10, 2021 | 9 a.m. EST / 6 a.m. PST Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 12 p.m. EST / 9 a.m. PST Global Clinical Quality April 7-8, 2021 | Virtual Event Learn what it takes to get a drug developed and approved April 13-14, 2021 | 12 p.m. EST / 9 a.m. PST
Learn the science driving biopharma. Specific for the non-scientist. April 20-21, 2021 | 12 p.m. EST / 9:00 a.m. PST 3rd Neuroimmunology Drug Development Summit 2021 April 27-29, 2021 Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. | 