Lilly's phase 2 Alzheimer's win marred by missed secondaries, questions about clinical significance Gilead, Merck join forces on long-acting HIV treatments Fierce Biotech’s top 10 data readouts in 2021 In Partnership: Meeting the challenge to deliver COVID-19 relief around the world Blown off course, Bluebird shares tick up on positive gene therapy readout After Mesoblast COVID-19 drug flop, Novartis tries again with Molecular Partners ElevateBio nets $525M to bolster cell, gene therapy platform After surprise FDA win, Aveo reverts to normal as partner splits, giving back unwanted asset Bicara debuts with $40M from Biocon to bankroll bifunctional antibodies How the gut microbiome is inspiring new approaches to treating brain disorders Cardinal Health to divest its Cordis device division in $1B deal #FierceMadness DTC advertising matchups are back! Vote for best pharma campaigns in annual NCAA-style competition Featured Story | By Nick Paul Taylor Eli Lilly has shared full data from a phase 2 clinical trial it hailed as showing a “significant slowing of decline” in Alzheimer’s disease patients. The donanemab data are a mixed bag, with a slight win on one disease scale undermined by a failure on a more widely used measure of Alzheimer’s. read more |
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Top Stories By Amirah Al Idrus Gilead Sciences and Merck each have new HIV medicines in late-stage trials, but the companies are teaming up to see whether their prospects might do better together. The duo will develop long-acting HIV treatments that combine their respective antiviral drugs: Gilead’s lenacapavir and Merck’s islatravir. 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 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 Nick Paul Taylor Bluebird bio has presented updated data on its cerebral adrenoleukodystrophy (CALD) gene therapy ahead of a planned filing for FDA approval. Most patients were alive and free from major functional disabilities after 24 weeks of follow-up, suggesting elivaldogene autotemcel stabilizes the disease. read more By Ben Adams Novartis is kick-starting a new trial with Molecular Partners for an experimental COVID-19 drug just a few months after another partnered attempt flopped. read more By Amirah Al Idrus After launching multiple companies and signing some partners, ElevateBio is grabbing another $525 million to fuel its work in cell and gene therapy. The funds will bolster its technology and manufacturing capacity and bankroll more partnerships as it works on its own pipeline. read more By Ben Adams After getting an FDA approval for its long-suffering cancer med from the FDA this month, Aveo’s brief positive news was upset by reverting to type after partner CANbridge said thanks but no thanks to an experimental drug. read more By Amirah Al Idrus Bicara launches with $40 million in seed money from Biocon to develop a pipeline of bifunctional antibodies. That includes lead program BC101, which zeroes in on EGFR-expressing cancer cells and blocks TGFβ, a protein that normally suppresses tumor growth but can be co-opted by cancer cells to promote their growth. read more By Arlene Weintraub Baylor researchers showed that treatment with the probiotic L. reuteri or a metabolite of it restored normal social behavior in mouse models of a developmental brain disease similar to autism. They believe their findings could inspire new treatments for brain disorders that include behavioral components. read more By Conor Hale After six years, Cardinal Health is dropping its Cordis medical device division, makers of cardiovascular catheters and diagnostic hardware, in a $1 billion deal with private equity firm Hellman & Friedman. read more By Beth Snyder Bulik March means #FierceMadness, our annual take on the March Madness NCAA basketball tournament and bracket mania—with a pharma twist. This year we’re pitting pharma's DTC advertising campaigns against one another on the road to the Final Four and ultimate championship. 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. | 