Health Canada approved Tagrisso (osimertinib) for patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer who have progressed on or after EGFR tyrosine kinase inhibitor therapy. Tagrisso, sponsored by AstraZeneca Canada, was granted Notice of Compliance with Conditions, based on promising evidence of clinical efficacy data, pending the results of additional... […]
FDA approved performing the Roche cobas HPV Test from cervical specimens collected in BD SurePath Preservative Fluid using the BD SurePath vial.
The European Commission approved a variation to the marketing authorization for Kyprolis (carfilzomib) to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The extended indication marks the second approval for Amgen's Kyprolis by the EC in less than a year.
FDA granted 510(k) clearance to the HARMONIC HD 1000i ultrasonic surgical device, developed by Ethicon, for use in open and laparoscopic procedures. The shape of the device mimics a mechanical dissector, reducing the need to use a separate dedicated dissecting instrument, according to Ethicon. HARMONIC HD 1000i is designed for use in numerous procedures and […]
FDA granted seribantumab, also known as MM-121, a Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer, whose disease has progressed following immunotherapy. Merrimack Pharmaceuticals, the drug’s sponsor, is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive […]
OmniSeq, a subsidiary of Roswell Park Cancer Institute, received New York State Clinical Laboratory Evaluation Program approval for its OmniSeq Comprehensive panel, a 144 gene, pan-cancer, next-generation sequencing tumor profiling diagnostic panel to guide oncology treatment decision-making. “OmniSeq is proud to receive New York State CLEP approval for OmniSeq Comprehensive. CLEP is the highest standard […]
Novartis entered into a collaboration and license agreement with Xencor Inc. to develop and commercialize novel therapeutics, including XmAb 14045 for acute myeloid leukemia, and XmAb 13676 for B-cell malignancies. Both are expected to begin development this year. Under the terms of the agreement, the parties will collaborate and share development costs for the worldwide […]
Hetero launched a biosimilar of bevacizumab in India for the treatment of metastatic colorectal cancer under the brand name Cizumab. The product has been approved by the drug controller general of India and has been recommended as a first-line treatment for mCRC. The product will be made available to patients in a single dose vial […]
FDA granted Fast Track Designation to ets-family inhibitor TK216 in Ewing sarcoma patients that have relapsed or are refractory to standard of care therapy. Oncternal Therapeutics Inc., the drug’s sponsor, is in the process of initiating a first-in-human phase I trial in relapsed or refractory Ewing sarcoma. TK216 is a first-in-class small molecule that inhibits […]
FDA approved Epclusa to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis, Epclusa is approved for use in combination with the drug ribavirin.
