Jubilant wraps up early clinical tests of oral remdesivir, plots further studies United Therapeutics seeks FDA approval of dry powder Tyvaso Zosano plots 2021 resubmission for once-rejected migraine patch Argenx taps Elektrofi to develop subcutaneous anti-FcRn drugs The top 15 biopharma licensing deals of 2020 Featured Story | By Nick Paul Taylor Jubilant Pharma has completed initial tests of its oral remdesivir formulation in healthy volunteers. The progress led Jubilant to seek authorization to run additional studies of its oral twist on Gilead’s intravenous COVID-19 antiviral. read more |
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Top Stories By Nick Paul Taylor United Therapeutics has filed for FDA approval of a dry powder inhalation formulation of treprostinil. The product, Tyvaso DPI, is part of United Therapeutics’ push to double the number of patients on an inhaled form of treprostinil by 2022. read more By Nick Paul Taylor Zosano Pharma has outlined plans to resubmit its migraine patch for FDA approval by the end of the year. The FDA rejected the drug-device combination Qtrypta last year, forcing Zosano to gather more pharmacokinetic data on the candidate before reseeking approval. read more By Nick Paul Taylor Argenx has teamed up with Elektrofi to develop subcutaneous formulations of drugs against FcRn and one other target. The aim is to provide self-administered, at-home versions of therapies such as argenx’s lead candidate efgartigimod. read more By Phil Taylor Oncology, specifically immuno-oncology, was the dominant theme in biopharma licensing last year, as cancer drugs accounted for half of the top deals. read more Resources 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: PerkinElmer Informatics Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes. Sponsored by: PulsePoint Access this guide for the latest insights into how marketers can use data, technology, and personalized messaging to build vaccine confidence and drive successful immunization efforts. 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: 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: 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: Catalent Discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes. Sponsored by: Catalent This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively. 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 In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Medical Affairs Strategic Summit (MASS) Virtual May 5-7, 2021 | Virtual Event TMF Virtual Summit May 18-20, 2021 | Virtual Event | 