Sandoz, a Novartis division focused on biosimilars, announced that it will not pursue its submission for biosimilar rituximab in the US at this time.
FDA has announced the availability of the MyStudies app, a mobile technology intended to foster the collection of real world evidence via patients' mobile devices.
Elsevier will integrate the National Comprehensive Cancer Network's Clinical Practice Guidelines in Oncology and utilize the NCCN Chemotherapy Order Templates as a reference into Via Oncology's Via Portal to provide clinical decision support at point of care and NCCN Guidelines concordance reporting.
Merck, known as MSD outside the United States and Canada, announced the FDA has approved Keytruda, Merck's anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer based on results from the KEYNOTE-407 trial.
Taiho Oncology, Inc. announced the FDA has accepted and granted priority review for the supplemental New Drug Application for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.
Genentech announced the randomized phase III CLL14 study, which evaluated fixed-duration Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia and co-existing medical conditions, met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (progression-free survival as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil.
TESARO Inc. announced the achievement of development milestones that trigger an $18 million payment from Janssen Biotech Inc.
Cofactor Genomics has launched an RNA-based immune profiling kit developed for laboratories wishing to derive the immune composition of tumor samples.
Taiho Oncology Inc. said FDA has accepted and granted priority review for the supplemental New Drug Application for Lonsurf (trifluridine/tipiracil, TAS-102) for previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.
Bristol-Myers Squibb Co. announced updates regarding regulatory actions by health authorities in the U.S. and European Union for the ongoing review of its applications for an indication in metastatic first-line non-small cell lung cancer with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden ≥10 mutations/megabase.
