| |JULY 20249GSK'S OMJJARA SECURES JAPANESE NOD FOR TREATMENT OF MYELOFIBROSISROCHE UNVEILS NEW ANALYTICAL UNITS FOR COBAS PRO INTEGRATED SOLUTIONSGSK plc, a biotechnology company, reported that Japan's Ministry of Health, Labour and Welfare (MHLW) has endorsed Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is an oral, once-daily inhibitor of JAK1/JAK2 and the activin A receptor type 1 (ACVR1). The endorsement depends on information from the pivotal phase III MOMENTUM and SIMPLIFY-1 trials.Following approvals under the brand name Omjjara from the European Commission and the Medicines and Healthcare Products Regulatory Agency in the UK, as well as approvals under the brand name Ojjaara from the US Food and Drug Administration, this is the fourth major regulatory approval for GSK's momelotinib in the treatment of myelofibrosis.Nina Mojas, senior vice president, oncology global product strategy, GSK, said: "Myelofibrosis has a heavy disease burden, with symptomatic patients experiencing spleen enlargement, fatigue, night sweats and bone pain, along with anaemia which can lead to treatment discontinuation and dependence on regular blood transfusions. With the approval of Omjjara, myelofibrosis patients in Japan will have a new treatment option for this complex blood cancer."The approval is based on the results of the pivotal phase III clinical trials MOMENTUM and SIMPLIFY-1. Energy was intended to assess the security and viability of momelotinib versus danazol for the treatment and decrease of key signs of myelofibrosis in a anaemic, symptomatic, JAK inhibitor-experienced population. SIMPLIFY-1 was developed to examine momelotinib and ruxolitinib's efficacy and safety in patients with myelofibrosis who had not previously been treated with a JAK inhibitor. PORoche, a leading biotechnology firm, declared the availability of its new analytical units, the cobas c 703 and cobas ISE neo, for the cobas pro integrated solutions, in nations accepting the CE mark. The cobas c 703 and cobas ISE neo logical units offer state of the art features to help address some of of the key difficulties faced by diagnostic laboratories worldwide comprises lack of qualified staff and space limitations. "Today more than ever, accurate and timely diagnostics is critical for effective delivery of healthcare. Labs are under increasing pressure to process more samples, at greater speed without compromising on accuracy," said Matt Sause, CEO of Roche Diagnostics. "With the launch of the cobas c 703 and cobas ISE neo, we are taking our latest generation clinical chemistry and immunochemistry platform, the cobas pro integrated solutions, to the next level. By integrating high-volume clinical chemistry testing and increased automation, we will set a new standard for high volume testing in the clinical lab."The new cobas c 703 insightful unit is intended to twofold the clinical chemistry throughput on cobas pro integrated solutions, presenting to 2,000 tests each hour and 70 reagent positions. With more onboard reagent capacity, more high-value tests can be run, workflow efficiency is improved, and reagent reloading time is reduced. This new unit will limit operator maintenance to one time each month, expanding uptime for laboratories. PO
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