Merck tips implant to give yearly HIV protection, plans phase 2 Capricor touts exosomes as better mRNA delivery vehicle Intellia advances CRISPR/Cas9 delivery to treat sickle cell FDA rejects rare disease drug, asks for prefilled syringe info Fierce Biotech’s top 10 data readouts in 2021 Featured Story By Nick Paul Taylor A phase 1 trial has found an implantable formulation of Merck’s islatravir could protect against HIV for at least one year. Merck is now preparing to start a phase 2 study of the subdermal implant. read more |
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| Top Stories By Nick Paul Taylor Capricor Therapeutics has shared early data on the exosome-mediated delivery of COVD-19 vaccines. The preclinical work furthers Capricor’s efforts to show its exosomes are a better delivery vehicle for mRNA than the currently used lipid nanoparticles. read more By Nick Paul Taylor Intellia Therapeutics has presented preclinical data on its bone marrow-tropic delivery system for in vivo genome editing. The study moves Intellia a step closer to its goal of systemically delivering CRISPR/Cas9 to treat diseases such as sickle cell. read more By Nick Paul Taylor The FDA has rejected PharmaEssentia’s request for approval of a treatment for a rare blood cancer. PharmaEssentia needs to provide more information about the instructions for the prefilled syringes used to administer the pegylated interferon. read more By Phil Taylor The first two entries in our 2021 clinical readouts list cover clinical trials of vaccines and therapeutics in COVID-19. Out list also covers familiar ground, featuring emerging drug candidates for cancer, diabetes, central nervous system disease, rare disorders and immunological conditions. read more Resources 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: 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: AmerisourceBergen Corporation Unlock product potential by making the most of your commercialization investments. Sponsored By: Acorn AI Unlock competitive advantage with AI and advanced analytics. Sponsored By: EVERSANA Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How. 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: Thermo Fisher Scientific Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain. Sponsored By: Blue Matter, strategic consultants in the life sciences A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones. Sponsored By: Baxter BioPharma Solutions While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery. 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 Latin America Healthcare Compliance Certificate Program April 19, 2021 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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