Scientists identify 40 potential drug targets in multiple myeloma study | EU expands indications for Sobi's Kineret | NHS turns down Roche's Alecensa as first-line treatment for lung cancer
April 12, 2018
DIA Global SmartBrief
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Scientists identify 40 potential drug targets in multiple myeloma study
Scientists identify 40 potential drug targets in multiple myeloma study
(Tim Sloan/AFP/Getty Images)
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.
GenomeWeb Daily News (free registration) (4/9) 
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EU expands indications for Sobi's Kineret
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.
PharmaTimes online (UK) (4/11) 
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NHS turns down Roche's Alecensa as first-line treatment for lung cancer
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.
PharmaTimes online (UK) (4/11) 
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New blood-free device developed for glucose monitoring
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.
Reuters (4/10) 
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Successful Development of CAR T-cell Therapies
Few companies possess all the necessary skills to develop CAR T-cell products. Whether companies build up capabilities internally, or augment with external resources, four areas of focus are key to successful development of CAR T-cell products. Learn what the four areas of focus are here.
Asia Pacific
Bangladesh plans to incentivize manufacture of pharmaceutical raw materials
Bangladesh plans to incentivize manufacture of pharmaceutical raw materials
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.
The Daily Star (Bangladesh) (4/11) 
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Ohara halves price of generic leukemia drug
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.
The Japan News by The Yomiuri Shimbun (4/11) 
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North America
FDA issues draft guidance for including pregnant women in clinical trials
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.
Regulatory Focus (4/6) 
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NIA proposes focusing on biomarkers, not symptoms, in Alzheimer's research
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.
HealthDay News (4/10) 
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Global Labeling Conference
DIA's Global Labeling Conference is the premier forum for regulators and industry to update their knowledge of local and global labeling-related policies and to examine the impact of changes on regulatory compliance. Register now!
Parexel, Japanese university to offer joint program in clinical research
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.
OutsourcingPharma (4/10) 
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Swiss biotech firm opens Texas gene therapy, cell manufacturing facility
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.
Genetic Engineering & Biotechnology News (4/10) 
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