Translate Bio's mRNA fails to improve lung function in cystic fibrosis patients Gilead, Novo Nordisk push NASH cocktail deeper into the clinic GSK licenses early-stage cancer, CNS programs to Boston Pharma—with repurchase option In Partnership: Meeting the challenge to deliver COVID-19 relief around the world Shire neuro head lands at Delix Therapeutics as CEO Sponsored: Avoiding Gene Therapy CMC and Clinical Supply Issues Aktis bags $72M in Novartis, BMS-backed series A to unlock power of radiopharmaceuticals GE Healthcare debuts pocket-sized, wireless ultrasound Featured Story | By Nick Paul Taylor A small clinical trial has found no pattern of improvements in lung function in cystic fibrosis patients who received Translate Bio’s mRNA prospect MRT5005. The setback, which sent the biotech’s stock down 24%, was softened somewhat by evidence that repeated inhaled doses of mRNA are safe. read more |
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Top Stories By Ben Adams After being encouraged by some early readouts, Gilead and Novo Nordisk are doubling down on their fatty liver R&D pact by kick-starting a midstage nonalcoholic steatohepatitis combo trial later this year. read more By Amirah Al Idrus When biopharma companies out-license programs, they’re usually kissing them goodbye. GlaxoSmithKline is farming out a pair of early-stage assets to its partner Boston Pharmaceuticals to develop through proof of concept—except, if the programs wind up back at the British drugmaker, it will be a success. read more In Partnership With: AmerisourceBergen Each challenge COVID-19 has presented in the past year has seemed insurmountable yet at every step those obstacles have been overcome, particularly in the pharmaceutical industry tasked with developing vaccines and therapies to combat this crisis. read more By Amirah Al Idrus Mark Rus, formerly Shire’s group vice president of neuroscience, is taking the helm at Delix Therapeutics, a biotech developing drugs that target neuroplasticity to treat central nervous system disorders. He arrives at Delix after a stint at Atlas Venture, where he led work on an early-stage, neuropsychiatry startup as an entrepreneur in residence. read more Sponsored By: Catalent Cell & Gene Therapy Gene therapy manufacturing and clinical supply strategies should be in place early to avoid potential late-stage development delays. read more By Nick Paul Taylor Aktis Oncology has raised a $72 million series A round to develop radiopharmaceutical treatments for solid tumors. The MPM Capital-founded biotech received investment from Novartis and Bristol Myers Squibb. read more By Conor Hale GE Healthcare launched a new handheld, wireless ultrasound device, capable of scanning anywhere within the body and small enough to be carried around in a clinician’s pocket. read more Resources 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: Uncountable Interested in moving from hand-written lab notebooks or spreadsheets to a modern research platform? Read this guide on Lab Information Management Systems (LIMS) to learn how modern companies are using software to innovate faster. 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: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. 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 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. Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 12 p.m. EST / 9 a.m. PST Global Clinical Quality April 7-8, 2021 | Virtual Event Learn what it takes to get a drug developed and approved April 13-14, 2021 | 12 p.m. EST / 9 a.m. PST
Learn the science driving biopharma. Specific for the non-scientist. April 20-21, 2021 | 12 p.m. EST / 9:00 a.m. PST Pharma PR & Communications Virtual Summit April 20–22, 2021 | Virtual Event 3rd Neuroimmunology Drug Development Summit 2021 April 27-29, 2021 Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. | 