Featured Story | By Ben Adams Johnson & Johnson saw its shares fall 4% in early trading on the news that its one-shot COVID-19 vaccine saw 66% efficacy in moderate to severe disease, rising to 85% in severe disease. read more |
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 | Thank you to Catalent for sponsoring this year's JPM 2021 coverage. |
|  | Transferring your procedures to Eurofins enables you to focus on critical in-house projects, advise virtually, expand capacity and reduce timelines. Choose our VC experts to ensure your products are GMP compliant and therapies get to patients sooner. Learn more. |
Top Stories By Nick Paul Taylor Novavax’s COVID-19 vaccine has achieved 89.3% efficacy in a phase 3 clinical trial that enrolled subjects exposed to the B.1.1.7 variant found in the U.K. However, the vaccine performed far worse in a smaller phase 2b that pitted it against another variant first identified in South Africa, intensifying concerns that updated prophylactics will be needed to protect against the evolving virus. read more By Ben Adams Rip up the rulebooks: It’s no longer investing 101, but investing 2021, where anything goes. read more By Amirah Al Idrus As regulators across the world make their way through the submission for what could be the first approved KRAS inhibitor, Amgen is unveiling its biggest data set yet in patients with non-small cell lung cancer. The drug, sotorasib, curbed tumor growth in 81% of patients and shrank tumors in 37% of them. read more By Nick Paul Taylor Arch Venture Partners has closed its largest fund to date. The new investment fund gives Arch $1.85 billion to support the creation and advancement of early-stage biotech companies. read more By Amirah Al Idrus Johnson & Johnson’s EGFR-MET bispecific antibody is padding its case ahead of a potential FDA nod. The drug shrank tumors in 40% of lung cancer patients with a rare EGFR mutation and curbed tumor growth in nearly three-quarters of patients. The phase 2 data come from 81 patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertions. read more By Angus Liu CRISPR-Cas9 has made waves in the biomedical world as a revolutionary gene editing tool, but it has its limitations. A team from the University of Illinois at Urbana-Champaign showed that an alternate technology, TALEN, is up to five times more efficient than CRISPR-Cas9 in highly compact forms of DNA. read more By Angus Liu A manufacturing shortfall likely cost Bristol Myers Squibb the chance of an FDA approval for CAR-T therapy liso-cel by the end of 2020—and sent a potential $9-apiece Celgene deal sweetener into the trash can. Investors looking for details of the expensive misstep now have the answers in an FDA Form 483. read more By Angus Liu Eli Lilly's COVID-19 antibody cocktail reduced hospitalization and death among high-risk patients. The Indianapolis pharma licensed a clinical-stage pain med from Asahi Kasei Pharma. Takeda reported positive results for its EGFR inhibitor in lung cancer. And more. read more By Fraiser Kansteiner Karuna Pharmaceuticals tapped neuroscience veteran Ronald Marcus, M.D., as its new SVP of medical. Roivant CEO Ramaswamy is moving up to an executive chairman role. Faze Medicines names Northern Biologics, Shire vet as CEO. 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 | 
