Featured Story | By Annalee Armstrong Tumor-attacking biotech Verseau Therapeutics has named a new CEO with a track record of moving biotechs from startup to M&A exit. John Edwards, who previously served as executive chair of Tilos Therapeutics, has joined Verseau, which focuses on cancer immunotherapies that reprogram the tumor microenvironment to attack tumors. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor The FDA has crushed Travere Therapeutics’ hopes of seeking accelerated approval in a rare kidney disorder on the strength of existing interim data from a phase 3 clinical trial. Travere said it may have enough data to meet the FDA’s demands by the first half of next year. read more By Annalee Armstrong Provention Bio’s stock flew skyward Tuesday as FDA advisory panel documents apparently backed the efficacy of its diabetes prevention drug teplizumab while avoiding a larger question about the quality of the biotech's manufacturing. read more By Ben Adams Preclinical biotech Lyell Immunopharma is looking to go public after a whirlwind year of big deals and big bucks raises as it looks to use cell therapy to beat solid tumors. read more By Ben Adams Larimar Therapeutics saw its shares nearly halved in after-hours trading last night after it was hit with an FDA trial hold and had to cancel a planned private raise. read more By Amirah Al Idrus Stephen Palmer, Ph.D., is a triple threat: he led the reproductive health research group at Merck KGaA, spun a biotech company out of the German pharma, and most recently, led a drug discovery team at Baylor College of Medicine. Now, he’s heading back to biotech as the chief scientific officer of Celmatix. read more By Kyle LaHucik NiKang Therapeutics, a clinical stage biotech, rakes in a $200 million series C from Cormorant Asset Management a month after hiring a CFO from the hedge fund. read more By Nick Paul Taylor Ysios Capital has closed its third fund at €216 million ($265 million). The fund, the largest raised by Ysios to date, equips the Spanish VC shop to invest in up to 15 companies in Europe and the U.S. read more By Amirah Al Idrus Brent Pfeiffenberger grew up at Bristol Myers Squibb, developing as a leader over a nearly 19-year tenure at the Big Pharma. Now, he’s taking his experience into the biotech world as the chief operating officer of Neogene Therapeutics, a transatlantic biotech working on next-generation T-cell therapies. read more By Conor Hale To help build out its own portfolio of artificial-intelligence-driven pathology tests, Quest Diagnostics has enlisted the help of Paige to develop a suite of products aimed at individual clinical oncologists as well as larger biopharma companies and their R&D efforts. read more Resources Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. 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: 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: 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. | 
