Featured Story | By Nick Paul Taylor A phase 2 clinical trial of Calithera Biosciences’ telaglenastat in renal cell carcinoma has missed its primary endpoint. The failure of the glutaminase inhibitor to improve progression-free survival (PFS) prompted Calithera to lay off 35% of its staff to stretch its cash reserves beyond future readouts. read more |
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Top Stories By Nick Paul Taylor RedHill Biopharma has presented phase 2 data on opaganib in COVID-19 patients on supplemental oxygen. The 40-subject trial linked the oral SK2 inhibitor to a numerical improvement in total oxygen requirement but was too small to provide conclusive answers. read more By Amirah Al Idrus 2020 didn't match 2018's record-breaking performance in the new drug approvals department, but it came pretty darn close. read more By Amirah Al Idrus Pfizer and Opko Health have filed their once-weekly growth hormone deficiency treatment for FDA approval, a decision the agency expects to make by October this year. The news comes after a phase 3 study showed the drug put less of a burden on patients than the established medicine, Pfizer’s Genotropin. read more By Ben Adams China-backed biotech Sinopharm has published a top-line view showing its COVID-19 vaccine is 79% effective, a fair chunk below the high efficacy seen from its rivals. The company previously said the vaccine was around 86% effective but gave no detailed evidence. Wednesday, in a press release, it said this number was in fact around 79%. read more By Angus Liu By using a combination of computational screening tools, scientists at the Chinese Academy of Sciences’ Shenzhen Institutes of Advanced Technology showed that Acrotech’s Folotyn, a chemotherapy originally developed to treat lymphoma, could potentially be repurposed to treat COVID-19. read more By Angus Liu For most of 2020, investors were placing bets on whether Bristol Myers Squibb would hit its targets to trigger a follow-up payment tied to its Celgene buyout. Short answer? It didn't. The FDA didn’t approve the CAR-T drug liso-cel by year-end as required—and disappointed investors might now channel their anger toward the company. read more Resources 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. 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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. | 
