Featured Story | By Annalee Armstrong In an unprecedented public rebuke, the FDA accused CytoDyn of trying to cherry-pick data from two failed studies of leronlimab in COVID-19 patients to claim the drug is effective. Plus, a stockholder has filed a class action lawsuit alleging that CytoDyn made false and misleading statements about the viability of leronlimab in treating COVID-19, a securities filing shows. read more |
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Top Stories By Ben Adams Bristol Myers Squibb, looking to the future beyond Opdivo, has penned a major biobucks pact for an early-stage assets out of small biotech Agenus. read more By Nick Paul Taylor Medicago and GlaxoSmithKline have presented interim phase 2 data on their adjuvanted COVID-19 vaccine candidate. The results suggest the plant-derived jab CoVLP+AS03 is somewhat differentiated from other vaccines through the mixed cellular response it triggers. read more By Kyle LaHucik Hummingbird Bioscience can chirp a little louder this morning with an oversubscribed $125 million series C led by Novo Holdings, the investment arm of Novo Nordisk. The Hummingbird financing signals one of the first investments in a privately held Asian biotech by the Danish pharma company. read more By Amirah Al Idrus Cyrus Mozayeni’s first go at vision-restoring gene therapies got snapped up as it was just getting started. Lots of suitors came knocking even when the company, Vedere Bio, was working under the radar, and Novartis eventually ponied up $150 million upfront to buy it. Now, Mozayeni and his team are reeling in $77 million to bankroll their second chapter: Vedere Bio II. read more By Nick Paul Taylor EureKARE has raised a $60 million series A round to fund the creation and advancement of synthetic biology and microbiome startups. The cash will enable eureKARE to build companies around science at European labs, bridging a perceived gap in the biopharma environment. read more By Andrea Park Abbott’s Navitor TAVR system is now available to Europeans with severe aortic stenosis and a high or extreme risk of complications from open heart surgery. read more By Angus Liu The clock’s ticking on the arrival of potentially the first China-made PD-1 inhibitor in the U.S. as the FDA has accepted Innovent Biologics and partner Eli Lilly's application for Tyvyt in front-line non-small cell lung cancer. We analyze the path from here on clinical data and, perhaps more importantly, pricing. read more |  | LabConnect is the leader in innovative central laboratory services for cell and gene therapies. Far more than typical central laboratory support, only LabConnect offers comprehensive, specialized services customizable to meet the unique needs of your complex clinical trials. Connect with us today. |
Resources Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 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: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. 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: 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. | 
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