Featured Story | By Nick Paul Taylor A phase 2/3 clinical trial of Biohaven Pharmaceutical’s troriluzole in Alzheimer’s disease has missed its co-primary endpoints. Biohaven, which slipped the news out on a federal holiday, is yet to quit on the program, though, pointing to a “nonsignificant numerical difference of a potential benefit” in a 97-subject subgroup to argue troriluzole may have a future in the indication. read more |
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 | Thank you to Catalent for sponsoring this year's JPM 2021 coverage. |
Top Stories By Ben Adams AbbVie and National Institutes of Health veteran Francesco Marincola, M.D., will become Gilead’s new head of cell therapy research out of its Kite unit. read more By Ben Adams Eli Lilly, via its Loxo Oncology biotech unit, is signing up to a three-therapy deal with Merus focused on T-cell redirecting bispecific antibody work. read more By Nick Paul Taylor Vera Therapeutics has raised $80 million to take a drug licensed from Merck KGaA into a phase 2b kidney disease clinical trial. The drug, atacicept, has failed multiple autoimmune clinical trials, but the leadership at Vera, which is heavy on former Gilead staffers, thinks it has a future in IgA nephropathy. read more By Amirah Al Idrus Gritstone Oncology, the biotech working on cancer vaccines based on traditional infectious disease immunology, is bringing that approach back to its roots. It’s working on a vaccine against SARS-CoV-2, the virus that causes COVID-19, that could also work against other viruses in this family in the case of a future pandemic. read more By Arlene Weintraub Drugs that target the cancer-promoting proteins MDM2 and BET have been tried in acute myeloid leukemia (AML) but haven’t been all that effective on their own. In a new study, combining the two approaches extended survival in mouse models of AML by activating the cancer-fighting protein p53 from two different angles. read more By Conor Hale Researchers at the University of Cambridge have developed a DNA test to help spot dangerous secondary infections that may develop during COVID-19 treatment—such as cases of pneumonia associated with ventilator equipment provided during intensive care. read more By Angus Liu Biopharma M&A activities suffered a slowdown in 2020. One could argue that 2019’s megadeals consumed some of last year’s quota, and COVID-19 definitely didn’t help. But AstraZeneca’s $39 billion deal for Alexion and Gilead’s $21 billion acquisition of Immunomedics showed the appetite for deal-making is still there. read more Resources Sponsored by: Cytiva It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. 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We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine. 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: Metabolon Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline. Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. 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 Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. 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. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! 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 about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. 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. | 
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