Herceptin First-Line Use In Breast Cancer Grows With 90% HER2 Testing
First-line use of Genentech's Herceptin (trastuzumab) is increasing with the growing number of breast cancer patients who are being tested for overexpression of the HER2 protein.
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The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.