Vir stock soars on blinded, 8-subject hepatitis B analysis Eli Lilly teams up with pharma rival GSK and partner Vir for COVID-19 antibody cocktail test Agios readies FDA filing as anemia drug clears another phase 3 Neurophth Therapeutics snags University of Louisville prof as new CSO Nuvalent nets $50M to create better targeted meds for cancer resistance Care Access Research teams up with AstraZeneca for COVID-19 antibody virtual trial work Sanofi, after R&D setback, lends a hand to vaccine rival Pfizer for coronavirus shot production Featured Story | By Nick Paul Taylor Shares in Vir Biotechnology rose 74% on the strength of data from a blinded, eight-subject cohort in its phase 1 hepatitis B trial. The analysis suggests the neutralizing monoclonal antibody may be more potent than expected and provides a boost to Vir’s prospects of delivering a functional cure. 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 Ben Adams COVID-19 has been a real leveler in competitor terms; once warring Big Pharmas have joined forces for the greater good on vaccines, both in R&D and more recently on production, and now on treatments. read more By Nick Paul Taylor A second phase 3 trial of Agios Pharmaceuticals’ mitapivat has hit its primary endpoint in patients with pyruvate kinase deficiency, keeping the biotech on track to file for approval on both sides of the Atlantic in the coming months. read more By Amirah Al Idrus Wuhan Neurophth Biotechnology signed a new chief scientific officer as it moves its gene therapy pipeline toward the clinic. Qiutang Li, Ph.D., joins from the University of Louisville School of Medicine, where she was a professor of ophthalmology and visual sciences for more than 14 years. read more By Amirah Al Idrus Targeted therapies have changed the game for cancer patients with tumor-driving mutations like ALK or ROS. But cancer cells can mutate their way around these drugs, developing resistance so they can keep growing. Nuvalent is working on new kinase inhibitors aimed at overcoming this resistance with fewer side effects than current options, and it’s starting with lung cancer. read more By Ben Adams Care Access Research is lending its decentralized clinical trial platform to AstraZeneca for its late-stage COVID-19 drug test. read more By Eric Sagonowsky Following its midstage coronavirus R&D setback, vaccine giant Sanofi is still looking for ways to help in the world’s effort to beat back the pandemic. It’s teaming up with leading vaccine players Pfizer and BioNTech to produce 100 million doses of the rival vaccine—even as Sanofi works to push its own programs through clinical testing. 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 | 