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Judge overrules Trump effort to advertise drug prices
A federal judge in the US has said that the Trump administration cannot require pharmaceutical companies to include drug prices in advertisements as it is beyond their authority.
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Routine mass analysis enables greater productivity in biopharma development
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
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Amgen and Astellas Pharma US agree to settlement costs for kickback charges
Amgen and Astellas Pharma US have agreed to pay a total of $124.75 million to settle allegations that they paid kickbacks to Medicare copays for their own medications.
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Genetically modified viral injection could treat metastatic melanoma
A study has reported that almost 40 percent of patients with non-surgically treatable tumours were effectively treated using a genetically modified virus...
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Aimovig approved by EU for migraine prevention
Researchers found that more than one quarter (26 per cent) of patients taking Aimovig 70mg were migraine free after month 15...
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Experimental drug eases effects of gluten for coeliac patients on gluten-free diet
First proof-of-concept study shows AMG 714 (anti-IL-15 monoclonal antibody) potentially protects celiac patients from inadvertent gluten exposure
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FDA approves Prolia for glucocorticoid-induced osteoporosis
The FDA has approved the use of Prolia for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture...
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T-VEC treatment shows promise for treating advanced stage liver tumours
Phase 1 data supports the use of image-guided therapy for difficult to treat cancer...
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EC approves first biosimilar Mvasi for the treatment of cancer
The European Commission has granted marketing authorisation for Mvasi for the treatment of certain types of cancer...
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EMA accepts MAA for romosozumab in the treatment of osteoporosis
The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture...
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AAM praises Supreme Court Ruling granting access to biosimilars
The Association for Accessible Medicines (AAM) applauded the US Supreme Court’s decision this week in Sandoz Inc. v. Amgen Inc. that will help speed patient access to biosimilar versions of expensive brand-name biologic medicines.
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Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research
16 May 2017 | By European Federation of Pharmaceutical Industries and Associations (EFPIA)
The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with quality medicines
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Novartis to globally co-commercialise Amgen’s migraine drug
27 April 2017 | By Niamh Marriott, Junior Editor
Novartis has expanded their commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine...
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New data adds to understanding of Repatha® (evolocumab) in multiple patient populations
23 August 2016 | By Amgen
Amgen will present data evaluating Repatha® (evolocumab) at the upcoming European Society of Cardiology (ESC) Congress 2016 in Rome...
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UCB and Amgen submit FDA application for Osteoporosis drug
22 July 2016 | By Niamh Louise Marriott, Digital Content Producer
UCB and Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture...
