HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications. “It is a relatively large number of approvals at one time, but the batch release of drug approvals is on an upward trend in Japan and other parts of the world,” Stephen Barker, equity analyst at Jeffries, told BioWorld. “There are a larger number of niche products being developed for relatively uncommon conditions.”
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
Biosimilars referencing Amgen Inc.’s rheumatoid arthritis drug, Enbrel (etanercept), could remain sidelined in the U.S. for nearly another decade, following a Federal Circuit decision Wednesday affirming the validity of two patents protecting etanercept and its manufacturing methods.
Bolstered by the success of CTLA4 and PD-(L)1 antibodies, companies are exploring new targets to encourage the immune system to attack tumors. "While these agents have demonstrated efficacy in a proportion of cancer patients, there clearly is room for improvement to lift the tail of the curve," Michele Teng, associate professor at the QIMR Berghofer Medical Research Institute, told the audience at the clinical trials plenary session of the American Association for Cancer Research Virtual Annual Meeting II, where researchers presented data from a pair of immunotherapies looking to build on the success targeting PD-(L)1.
Four years after the EMA first approved Novartis AG's Ilaris (canakinumab) for the treatment of adult-onset Still’s disease (AOSD), the FDA has followed suit, giving it a green light in the indication following a priority review. The rare rheumatic condition usually affects younger adults and can occur as infrequently as once, but also intermittently or chronically.
Now that Roche Holding AG has digested its Foundation Medicine and Flatiron acquisitions from a few years ago, it has looked to add more digital capabilities in a couple of recent deals. The earlier big-ticket tie-ups by the Basel, Switzerland-based pharma added genomic and real-world data analytics to deepen the knowledge driving Roche’s R&D efforts, particularly in oncology.
A key opinion leader (KOL) consulted by SVB Leerink deemed Roche Holding AG’s anti-TIGIT drug results “really huge” and “quite amazing,” affirming the Basel, Switzerland-based firm’s lead in the field. The phase II data from the study known as Cityscape rolled out at the virtual American Society of Clinical Oncology (ASCO) meeting.
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of a historic first vaccine approval, having secured a positive vote May 29 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo).
Pharma and diagnostics giant Roche Holding AG, of Basel, Switzerland, has acquired Seattle-based Stratos Genomics Inc., an early-stage sequencing technology company, in a move aimed at advancing development of Roche’s nanopore sequencer. Financial terms of the deal, which was first reported on Friday, were not disclosed.