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Merck Gardasil gets priority

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's action date for Merck's human papillomavirus vaccine Gardasil is June 8 following the agency's priority review designation, announced Feb. 7. Merck adds that "since submission to the FDA in December, Merck has also submitted applications for Gardasil to additional regulatory agencies including those in the European Union and Australia, Mexico, Brazil, Argentina, Taiwan and Singapore." GlaxoSmithKline recently said it plans to file a BLA for its HPV vaccine Cervarix by year-end...

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Approvals In Brief

Merck’s HPV vaccine Gardasil clears FDA June 8 for use in females ages nine to 26; CDC’s AdvisoryCommittee on Immunization Practices will review the vaccine June 29. Teva’s Parkinson’s disease therapy Azilect is approved May 16 with a Phase IV study focused on melanoma risk. Johnson & Johnson’s Remicade expands its Crohn’s disease labeling to include pediatric patients. More approvals in brief

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 Keeps Commitment To External Cancer Innovation

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.





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