Johnson & Johnson's closely watched single-shot COVID-19 vaccine readout 'next week' as CFO sees 'robust data' Immunocore IPO filing reveals kickback scheme, Immatics row and phishing attacks CNS-focused Karuna snags BMS vet to spearhead clinical pipeline Iterum nabs speedy FDA antibiotic review, but follows in the footsteps of bankrupt biotechs Nirogy Therapeutics emerges with $16.5M to target metabolite transporters Lilly antibody combo slashed COVID-19 deaths, hospitalizations in high-risk patients Featured Story | By Ben Adams While the world struggles with two-shot vaccine production as a handful of pharma companies try to make enough for almost the entire global population, a single-dose option from Johnson & Johnson has become a major hope in the fight against COVID-19. read more |
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Top Stories By Nick Paul Taylor Immunocore’s filing for a $100 million IPO has revealed a range of issues affecting the TCR bispecific immunotherapy developer, including a kickback scheme run by a former employee and a trademark row with Immatics. read more By Amirah Al Idrus Karuna Therapeutics is adding a neuroscience veteran to its ranks as it moves its lead program through late-stage development. Ronald Marcus, M.D., is the company’s new senior vice president of medical, joining the team responsible for its clinical-stage pipeline, including KarXT, a treatment that combines xanomeline—an Eli Lilly castoff—and trospium chloride read more By Nick Paul Taylor The FDA has accepted Iterum Therapeutics’ oral sulopenem for priority review in the treatment of certain uncomplicated urinary tract infections. Securing the speedy review positions Iterum to learn whether the FDA will approve the drug by July 25. read more By Amirah Al Idrus After years working under the radar, Nirogy Therapeutics is officially launching with $16.5 million and a mission to drug a family of membrane proteins called solute carriers. The proceeds will see the company’s lead cancer program through phase 1, CEO Vincent Sandanayaka, Ph.D., said. read more By Eric Sagonowsky Amid new worries about COVID-19 vaccine supplies, monoclonal antibodies—such as those from Eli Lilly and Regeneron—could be important stopgaps to reduce deaths and hospitalizations until vaccinations gain steam. And Lilly is touting data showing two of its antibodies did just that in high-risk patients. read more | | Experts in our field with 20+ yrs. experience in Viral Vector & Plasmid DNA (R&D, “HQ” High Quality, GMP) manufacture. Now part of the Cognate BioServices family, Your CDMO partner from concept to commercial for cell & gene therapy products. Learn 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. Sponsored By: Blue Matter Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.” Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: GenScript A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields. Sponsored by: Catalent Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity. Sponsored by: AllianceRx Walgreens Prime Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. 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: 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: 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: 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: 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. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Virtual Clinical Trials Summit February 9-10, 2021 | Virtual Event Learn what it takes to get a drug developed and approved February 23-24, 2021 | 9:00am-3:30pm PST For non-scientists. Learn the science driving biopharma. February 25-26, 2021 | 9:00am-3:30pm EST Learn what it takes to get a drug developed and approved March 9-10, 2021| 9:00am-3:30pm EST Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 9:00am-3:30pm PST Learn what it takes to get a drug developed and approved April 13-14, 2021 | 9:00am-3:30pm PST
Learn the science driving biopharma. Specific for the non-scientist. April 20-21, 2021 | 9:00am-3:30pm PST Learn what it takes to get a drug developed and approved April 22-23, 2021 | 9:00am-3:30pm EST Learn the science driving biopharma. Specific for the non-scientist. May 6-7, 2021 | 9:00am-3:30pm EST Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 9:00am-3:30pm PST Learn what it takes to get a drug developed and approved June 2-3, 2021 | 9:00am-3:30pm EST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9:00am-3:30pm EST | 