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 […]
MARK SOCINSKI was named executive medical director of the Florida Hospital Cancer Institute. He will oversee the coordination of clinical cancer services for the Florida Hospital network. He will also be a member of the institute's Thoracic Oncology Program.
The House Appropriations Subcommittee on Labor-HHS marked up a bipartisan spending bill July 6 that gives NIH a $1.25 billion increase in the 2017 fiscal year.
Gilman's resignation enabled him to retain the most precious of all privileges: the ability to look at himself in the mirror.
Stanford Cancer Institute earned the NCI Comprehensive Cancer Center designation, becoming the eighth institution in California to earn this highest level of recognition.
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 […]
