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When to Use FDA’s Pre-Submission ProgrammePharma consultants: Did you know there is a medical device programme that is beneficial to some aspects of drug applications? FDA's Pre-submission programme was formerly known as the pre-IDE (Investi2016/6/3
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Recordati takes over Italian pharmaceutical company Italchimici for €130mInternational pharmaceutical group Recordati has acquired 100% stake in Italian pharmaceutical company Italchimici for €130m. Recordati has made the acquisition from Progressio SGR, manager of the fu2016/6/3
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Roche’s MabThera SC receives EC approval to treat chronic lymphocytic leukaemiaSwiss pharmaceutical company Roche has received approval from the European Commission (EC) for the subcutaneous (SC) formulation of MabThera (rituximab), to treat people affected with previously untre2016/6/2
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EMA recommends marketing authorisations for Epclusa and Zepatier to treat hepatitis C virusThe European Medicines Agency (EMA) has recommended the approval of marketing authorisations for two latest combination therapies against chronic (long-term) hepatitis C virus (HCV) infection in the E2016/6/2
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EMA recommends marketing authorisations for Epclusa and Zepatier to treat hepatitis C virusThe European Medicines Agency (EMA) has recommended the approval of marketing authorisations for two latest combination therapies against chronic (long-term) hepatitis C virus (HCV) infection in the E2016/6/1
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CSL Behring receives FDA approval to treat haemophilia ACSL Behring has received approval from the US Food and Drug Administration (FDA) for the use of its recombinant factor VIII single-chain therapy, Afstyla, as a treatment for haemophilia A. Hemophilia2016/6/1
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Inserm researchers develop new drugs to treat skin cancerA team from French National Institute of Health and Medical Research Inserm led by Stéphane Rocchi has synthesised and developed new drugs to treat melanoma, a highly malignant form of skin cancer. O2016/5/31
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Samsung Bioepis secures EC approval to market RA biosimilar Flixabi in EUSamsung Bioepis, a joint venture between Samsung BioLogics and Biogen, has secured approval from the European Commission (EC) to market rheumatoid arthritis (RA) biosimilar, Flixabi, in the European U2016/5/31
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M&As this week: Biodel, Dirui Industrial and THERAMetricsBiodelhas entered an agreement to merge with Albireo Pharma, Inc. to form a combined company whereby the former's shareholders will own 33% and the latter's will own the rest. The new company will fo2016/5/30
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US FDA grants Fast Track Designation to Novavax’s RSV F VaccineThe US Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax's respiratory syncytial virus (RSV) F-Protein nanoparticle vaccine candidate (RSV F Vaccine) that can be used to2016/5/30