Endocyte Back On Track To File Lead Candidate For EU Conditional Approval This Year
This article was originally published in Pharmaceutical Approvals Monthly
The U.S. biotech, which went public last year, plans to file EC145 and a companion diagnostic for conditional approval in Europe in platinum-resistant ovarian cancer in the third quarter, based on findings from four Phase I and Phase II trials.
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With its cash position bolstered by a pair of public equity offerings this year, Endocyte Inc. is pressing ahead with its novel therapeutic and diagnostic platform, initiating late-stage trials in platinum-resistant ovarian cancer (PROC) and non-small-cell lung cancer (NSCLC), with a plan to seek a first approval in Europe.
Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty
The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.