EU backs fully subcutaneous regimen of Remicade biobetter Liquidia, Sandoz set to challenge United Therapeutics for subcutaneous Remodulin market 89bio gets green light to take liquid NASH prospect into phase 2 MIT team uses machine learning to find nanoparticles with high drug-loading capacities The top 10 pharma R&D budgets in 2020 Featured Story | By Nick Paul Taylor The European Medicines Agency (EMA) has backed the use of Celltrion Healthcare’s subcutaneous infliximab without initial intravenous loading doses. Securing the regulatory recommendation boosts Celltrion’s efforts to outcompete Johnson & Johnson’s Remicade and its biosimilar rivals. read more |
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Top Stories By Nick Paul Taylor Liquidia and Sandoz are poised to introduce a generic, subcutaneous version of United Therapeutics’ Remodulin to the U.S. market. Details of the planned launch emerged after Liquidia’s partner secured FDA 510(k) clearance for medication cartridges. read more By Nick Paul Taylor 89bio is set to take a liquid formulation of its nonalcoholic steatohepatitis candidate into a phase 2b clinical trial after reaching an agreement with the FDA. The new formulation is intended to provide patients with a more convenient administration method that supports compliance. read more By Nick Paul Taylor Massachusetts Institute of Technology researchers have used machine learning to identify pairs of small-molecule drugs and inactive ingredients that will self-assemble into nanoparticles with high therapeutic payloads. read more By Ben Adams While 2020 was a year to forget for almost the entire globe, the R&D engine of pharma roared to life in a never-before-seen way by creating new drugs, vaccines and tests for the pandemic that ravaged the world. read more Resources 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: 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: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: OCT Clinical Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical. 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: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Almac Clinical Technologies This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty. 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. BD&L Summit for Life Sciences March 9–10, 2021 | Virtual Event Global Clinical Quality April 7-8, 2021 | Virtual Event Neuroprotection: Opportunities in Retinal Neurodegenerative Diseases April 13, 2021 | 1:15p.m. ET / 10:15a.m. PT Pharma PR & Communications Virtual Summit April 20–22, 2021 | Virtual Event Learn core elements: pricing, competitive assessments and epidemiology April 28-29, 2021 | 9:00am-3:30pm PST
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