Forty genes have been identified by investigators from London's Institute of Cancer Research that could become potential therapeutic targets. As reported in the journal Leukemia, the researchers were able to pinpoint coding and noncoding mutations linked to the development of multiple myeloma while examining whole-genome sequencing data from 765 patients.
European regulators expanded treatment indications for Sobi's Kineret, or anakinra, to treat the rare auto-inflammatory disorder Still's disease. This move was supported by clinical research showing remission in the majority of pediatric and adult patients taking the drug.
The NHS will not fund Roche Holding's Alecensa, or alectinib, as a first-line treatment for lung cancer. In its decision, the National Institute for Health and Care Excellence cited uncertainty about whether the drug prolonged survival, although evidence suggested it was more effective than crizotinib in slowing disease progression.
A new blood-free monitoring device can measure glucose levels in the interstitial fluid directly beneath the skin. The device is still in early development at the University of Bath in the UK and so far has been tested in two healthy volunteers, with results matching glucose levels in blood.
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The Bangladesh government plans to offer incentives for the domestic production of raw materials for the country's pharmaceutical industry, which currently imports the materials from China, South Korea and India. The proposal would give a tax holiday to producers of laboratory reagents and APIs for five years, with additional incentives for tax breaks beyond that time frame.
Ohara Pharmaceutical halved the price of its generic version of Glivec in Japan in a bid to make medications more affordable for patients with chronic myelocytic leukemia. Currently, 17 pharmaceutical companies offer a generic version of Glivec, but market penetration is low because of high prices.
Draft FDA guidance calls for including pregnant women in clinical trials with "careful attention to potential fetal risk" and under the guidance of bioethicists and maternal health experts. "Pregnant women can be enrolled in clinical trials that involve greater than minimal risk to the fetuses if the trials offer the potential for direct clinical benefit to the enrolled pregnant women and/or their fetuses," the guidance reads.
Alzheimer's disease research should focus on biologic and physical markers of the disease instead of on symptoms, according to new research guidelines from the National Institute on Aging. The proposed framework, published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, is in line with protocols for other disease research and present an opportunity to develop prevention strategies, experts said.
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Parexel and Meiji Pharmaceutical University announced a plan to help expand the biopharmaceutical workforce in Japan by launching a joint program for clinical research and clinical trial management at the Tokyo school. The four-week undergraduate curriculum will be preceded by a series of two-week pilot programs, with the full curriculum being offered beginning in November 2019.
Lonza, a chemicals and biotechnology company based in Switzerland, opened its 300,000-square-foot production facility in Pearland, Texas, which will focus on manufacturing hundreds of batches of viral vectors each year for clients who are developing autologous cell and gene therapy projects. Lonza also announced plans in February to build three more Centers of Excellence for Cell and Gene Therapy around the world.