Featured Story | By Nick Paul Taylor Ex-Gilead CSO Norbert Bischofberger has struck a deal with his former employer. The agreement will see Bischofberger’s Kronos Bio buy Gilead’s portfolio of spleen tyrosine kinase inhibitors and vault into clinical development. read more |
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|  | Your clinical packaging strategy is key to a successful trial. When developing your strategy, it’s important to consider your patients' and healthcare providers' needs as well as packaging options and automation. Download our eBook to learn more. |
Top Stories By Ben Adams Relay Therapeutics has pulled off a major upsized IPO worth $400 million to propel a pipeline of treatments aiming at previously undruggable targets. read more By Amirah Al Idrus Suppressing cough in COVID-19 patients not only addresses a symptom that can be “traumatic and debilitating,” but it can tamp down on the spread of the disease from patients to hospital staff, family or housemates. Nocion Therapeutics scored expedited approval for the phase 1 study of its cough treatment. read more Monday, July 13, 2020 The inclusion of Kupffer cells in in vitro hepatic cultures provides researchers with advanced tools for disease modeling and drug discovery. read more By Amirah Al Idrus An FDA panel has narrowly backed the approval of Mallinckrodt’s terlipressin for a type of kidney failure. The 8-7 vote comes after FDA staffers flagged multiple concerns for the drug, including whether meeting the surrogate endpoint in its phase 3 study actually translated to patients living longer or faring better. read more By Amirah Al Idrus Coronaviruses have jumped from animals to humans before—and they’ll do it again. That’s why Adagio Therapeutics is working on antibodies that can fight multiple members of the virus family, including SARS-CoV-2, the culprit behind the current pandemic. The startup snagged $50 million to push its lead candidates into the clinic. read more By Nick Paul Taylor Imvax has raised $112 million to take its autologous tumor cell vaccine into a phase 2 glioblastoma multiforme trial. The series C follows phase 1b data on the brain cancer treatment that persuaded existing investors including HP WILD Holding and Ziff Capital Partners to commit more cash. read more By Conor Hale Glympse Bio, developers of an injectable chemical biomarker platform for diagnosing the body’s hidden diseases, has raised $46.7 million in new funding for its efforts. read more By Eric Sagonowsky Several biopharma players are racing to deliver COVID-19 vaccines, and now Johnson & Johnson is revving up its plans for late-stage trials earlier than originally expected—and it's aiming far above the FDA's 50% efficacy bar for approval, executives said. If its candidate succeeds in the clinic, J&J plans to be ready to launch in early 2021. read more |  | Webinar: Metabolites in Safety Testing (MIST): Analytical Strategy Wednesday, July 29 | 1pm ET / 10am PT Regulatory agencies have provided recommendations on when and how to identify and characterize drug metabolites to ensure their non-clinical toxicity has been adequately evaluated. This presentation will review the origins of these recommendations and the specific requirements that need to be considered in designing studies. Register now. |
Resources Sponsored by: Lonza Pharma & Biotech A novel spray-dried dispersion platform has been developed to faciliate high drug load applications Sponsored by: Florence Complimentary Download: How to connect to study sites remotely via the Electronic Investigator Site File (eISF) to streamline clinical operations. Insights from the largest eISF network in the world. Sponsored by: PRA Health Sciences Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need. Sponsored by: Cytiva On-demand video: fuel gene therapy development and production with modern AAV workflows. With today’s rapidly evolving environment, we have created this five-part content series to highlight pressing issues and topics that are more pertinent today than ever before. Sponsored by: Cambrex The industry trend of outsourcing to CDMOs continues. With more services, capabilities, facilities, and employees than ever before, our experts have contributed more articles to our biggest eBook yet. Sponsored by: EVERSANA How predictive analytics and machine learning have the potential to transform healthcare by predicting “Patient Switching Behaviors.” Sponsored by: Recro Gainesville Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project. Sponsored by: Systech Get an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain. Sponsored by: Automation Anywhere Built on advances in Artificial Intelligence (AI), data mining, and information integration into various systems at 100% accuracy, the new era of intelligent automation is integral to life sciences for devising new treatments faster and at a lower expense. Sponsored by: Research Solutions Learn four ways to squeeze more value from your limited R&D resources. Sponsored by: BioAnalytix Download this eBook and Learn the Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. 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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