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FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib

May 30, 2018
Astellas Pharma announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company's New Drug Application (NDA) for gilteritinib for the…
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Luye Pharma Acquires AstraZeneca’s Signature Products Seroquel and Seroquel XR

May 29, 2018
Luye Pharma Group recently announced their acquisition of AstraZeneca's core CNS products - Seroquel and Seroquel XR. As with previous acquisitions such as Lipusu, Xuezhikang, Beixi and…
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Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder

May 29, 2018
Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of…
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Ingestible “bacteria on a chip” could help diagnose disease

May 28, 2018
MIT researchers have built an ingestible sensor equipped with genetically engineered bacteria that can diagnose bleeding in the stomach or other gastrointestinal problems. This…
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NIH begins testing Ebola treatment in early-stage trial

May 28, 2018
A first-in-human trial evaluating an experimental treatment for Ebola virus disease has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland. The Phase 1…
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Beactica Signs Three-Year Extension Agreement With Sanofi

May 28, 2018
Beactica announced that it has signed a three-year extension of its master services agreement with Sanofi. The agreement outlines the legal terms under which Beactica and Sanofi…
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Global Device Week – 5 high caliber events join forces to boost Medical Innovation at Medical Fair…

May 28, 2018
Supported by Suzhou Government, MDS joins forces with major partners in various medical sectors and together stage the first Global Device Week in Suzhou from 6-9 September 2018 –…
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FDA approves a new treatment for PKU, a rare and serious genetic disease

May 25, 2018
The U.S. Food and Drug Administration approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born…
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Avara Pharmaceutical Services Acquires Major Sterile Manufacturing Facility and Development Center…

May 25, 2018
Avara Pharmaceutical Services announced that it has agreed to acquire the largest sterile manufacturing facility for injectable medicines in Canada from a leading global pharmaceutical…
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Samsung BioLogics Receives an additional FDA Approval for its world largest Plant’s Production

May 25, 2018
Samsung BioLogics announced that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant, the world's largest…
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Press Releases

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