Regulatory authorities in six countries have granted 10 sales authorizations for Yondelis. Five of those authorizations are for Yondelis (trabectedin) in combination with Caelyx (pegylated liposomal doxorubicin) for treating relapsed platinum-sensitive ovarian cancer, in Bangladesh, Costa Rica, Kuwait, Moldavia and Saudi Arabia The other five authorizations are for Yondelis for soft tissue sarcoma, in Bangladesh,... […]
FDA approved the American College of Radiology’s alternative standard request to allow mammography facilities to use the new Digital Mammography Quality Control Manual and Digital Mammography QC Phantom in routine QC of digital equipment. The new manual and phantom will aid in ensuring uniformity of QC testing, the ACR said. The FDA alternative standard specifies... […]
Veritas Genetics introduced Veritas myGenome, a whole genome sequencing platform for less than $1,000, including interpretation and genetic counseling. The platform includes a digital report and app to interact with results, on-demand additional genetic counseling via video conferencing, and lifestyle-relevant genetic information that can be shared with non-clinical service providers such as fitness coaches and... […]
NanoString Technologies Inc. entered into a collaboration agreement with Merck, through a subsidiary, to develop and commercialize a novel diagnostic assay to predict response to Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. Under the terms of the collaboration agreement, NanoString will be responsible for seeking regulatory approval for and commercialization of the diagnostic test. NanoString will be... […]
Merck KGaA, Pfizer and Verastem entered into an agreement to evaluate avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Verastem’s VS-6063, an investigational focal adhesion kinase inhibitor, in patients with advanced ovarian cancer. Avelumab is currently under clinical investigation across a broad range of tumor types. The phase I/Ib clinical trial... […]
FDA and the European Medicines Agency have both granted Orphan Drug Designation to FLAG-003 for the treatment of glioma, sponsored by FLAG Therapeutics. Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases, those which affect fewer than 200,000 Americans annually. Orphan drug... […]
The European Medicines Agency granted an Orphan Drug Designation to venetoclax, an investigational, oral B-cell lymphoma-2 inhibitor, for the treatment of acute myeloid leukemia. Venetoclax is being developed by AbbVie in partnership with Genentech and Roche. The EMA previously granted Orphan Drug Designation to venetoclax for the treatment of chronic lymphocytic leukemia. Orphan Designation is... […]
FDA granted orphan drug designation to the WT1 cancer vaccine developed by SELLAS Life Sciences Group for the treatment of patients with malignant pleural mesothelioma. SELLAS recently reported positive results of a phase II trial of its WT1 vaccine in MPM patients, showing that overall survival improved and progression-free survival doubled. Based on these findings,... […]
Health Canada approved Opdivo injection (nivolumab), the first and only immuno-oncology therapy approved in Canada for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. The approval was made under the Health Canada Priority Review process, after having met the criteria of substantial... […]
FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia.
