Featured Story | By Nick Paul Taylor A phase 3 clinical trial of Amicus Therapeutics’ late-onset Pompe disease prospect has missed its primary endpoint. Yet Amicus looked past the failure of AT-GAA to improve statistically on Sanofi’s market incumbent Lumizyme, zeroing in on details of the data to justify forging ahead with plans to seek approval of the candidate. read more |
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Top Stories By Ben Adams Bristol Myers Squibb is putting down up to $1.3 billion on a next-gen engineered toxin body cancer platform from Molecular Templates as it cuts an unwanted cell therapy from its Celgene buyout. read more By Amirah Al Idrus Roche’s bispecific antibody matched Regeneron’s blockbuster Eylea in four phase 3 studies comparing the two in diabetic macular edema and wet age-related macular degeneration. The studies found the experimental drug did no worse than the incumbent despite a majority of the patients going longer between injections. read more Sponsored By: Avid Bioservices The concept of one-stop shopping has become more popular in the biopharmaceutical industry in recent years, prompting many traditional commercial manufacturing organizations (CMOs) to provide support to clients throughout the manufacturing lifecycle. read more By Ben Adams Neurodegenerative biotech and pharma friend Denali has revealed a positive peek at some early Hunter syndrome data. read more By Nick Paul Taylor Takeda has shared results from a successful phase 3 clinical trial of maribavir in transplant recipients with refractory cytomegalovirus infection. The trial suggests maribavir is better at clearing the virus from the blood than existing treatments such as ganciclovir and valganciclovir. read more By Conor Hale Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point of care. read more By Arlene Weintraub A study of 99 glioblastoma tumors resulted in a map of genes, proteins, cells and signaling pathways that are active in the disease. The map revealed potential new protein targets, as well as four different immune subtypes of glioblastoma that could point to effective immunotherapy strategies, the researchers said. read more By Amirah Al Idrus Moderna is in talks with South Korea for a new $200 million vaccine production plant. Eli Lilly scored an emergency nod for its Junshi-partnered COVID-19 antibody cocktail. AstraZeneca joined forces with Hong Kong Science and Technology Parks to set up an incubator for startups working to improve the treatment and diagnosis of cancer. And more. read more By Fraiser Kansteiner Ex-bluebird cancer research chief Frank Neumann lands at Gilead's Kite Pharma after a brief stopover at Verastem. Hot on the heels of fresh CEO grab, Penrose TherapeuTx signs new chief development officer. Editas chair Mullen to step up to CEO plate from Feb. 15. read more Enrollment Showcase | Sponsored by: University of Florida College of Pharmacy Learn about the Top 5-Ranked UF College of Pharmacy’s online graduate programs in pharmaceutical outcomes & policy. Select from five specializations, including the new pharmaceutical value assessment & communication option. Over half of graduates progress to a new role within one year. Register now. |
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Resources Sponsored By: Medidata, a Dassault Systèmes company 8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook. Sponsored By: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored By: Acorn AI, a Medidata Company Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. Sponsored By: Outer Edge Technology Criminals Are Actively Exploiting The CV-19 Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become A Cybercrime Statistic -- Make These Cost-Effective IT Changes Now! 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: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule 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: Premier Research Browse the latest learnings and insights from our clinical development professionals. 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 what it takes to get a drug developed and approved February 23-24, 2021 | 12 p.m. EST / 9 a.m. PST For non-scientists. Learn the science driving biopharma. February 25-26, 2021 | 9 a.m. EST / 6 a.m. PST BD&L Summit for Life Sciences March 9–10, 2021 | Virtual Event Learn what it takes to get a drug developed and approved March 9-10, 2021 | 9 a.m. EST / 6 a.m. PST Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 12 p.m. EST / 9 a.m. PST 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 Learn what it takes to get a drug developed and approved April 22-23, 2021 | 9:00 a.m. EST / 6 a.m. PST Learn the science driving biopharma. Specific for the non-scientist. May 6-7, 2021 | 9:00 a.m. EST / 6 a.m. PST Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 12 p.m. EST / 9 a.m. PST Learn what it takes to get a drug developed and approved June 2-3, 2021 | 9 a.m EST / 6 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. | 
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