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FDA delivers Form 483 to Eisai plant in U.S.Japan’s Eisai, which has reduced its manufacturing operations in the U.S., is now facing regulatory concerns for a plant in Baltimore, Maryland. The facility has received an FDA Form 483 with 5 obser2017/2/24
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Liquid biopsies in melanoma – transformation of patient care tantalizingly closeAn innovative blood test is now being used in Melbourne, Australia, which allows the diagnosis of melanoma sooner and gives patients the best chance of survival. In November 2016, the Olivia Newton-Jo2017/2/23
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US FDA grants fast-track designation to Cell Medica's CMD-003The US Food and Drug Administration (FDA) has granted fast-track designation to UK-based cellular immunotherapy firm Cell Medica's oncology product CMD-003 (baltaleucel-T). The designation includes t2017/2/23
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Recipharm acquires Kemwell’s pharmaceutical businesses in India for $118.5mSweden's Recipharm has completed the previously announced acquisition of Kemwell’s pharmaceutical businesses in Bengaluru, India, in a deal valued at Skr1.05bn ($118.5m). The acquisition was initiall2017/2/22
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Mereo BioPharma’s BPS-804 drug accepted for participation in EMA’s adaptive pathways programmeUK-based biopharmaceutical company Mereo BioPharma has announced that its BPS-804 drug has been accepted to participate in the European Medicines Agency’s (EMA) adaptive pathways programme. As part o2017/2/22
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Amygdala Neurosciences to acquire GS-6637 from Gilead SciencesUS-based Amygdala Neurosciences has signed an agreement to acquire GS-6637, a ALDH2 inhibitor from Gilead Sciences. GS-6637 is a Phase II ready compound with the potential to treat behaviour and subs2017/2/21
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Japan’s Takeda acquires US cancer drug manufacturer ARIAD for $5.2bnJapan-based Takeda Pharmaceutical Company has completed the previously announced acquisition of American oncology company ARIAD Pharmaceuticals for $5.2bn. The acquisition was concluded through a ten2017/2/21
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ALK receives acceptance for ragweed sublingual allergy immunotherapy tabletDanish-based pharmaceutical company ALK’s European regulatory filing for its ragweed sublingual allergy immunotherapy (SLIT) tablet has received acceptance from the relevant health authorities. The f2017/2/20
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Vedanta, Stanford and Leiden universities partner to study food allergies in childrenUS-based Vedanta Biosciences has collaborated with Stanford University School of Medicine and Leiden University Medical Center to study food allergies in children and patients with C difficile infecti2017/2/20
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Sanofi, Novo and Lilly face class action over 'astounding' insulin price hikesAn “insidious” pricing war has left patients with huge, “devastating” bills for their needed insulins, according to a new class actionlawsuitfiled against Sanofi, Novo Nordisk and Eli Lilly. The plai2017/2/17