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EMA and FDA establish new cluster to support medicine development for rare diseasesThe European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have established a new cluster to boost the development of medicines for rare diseases. The new cluster wi2016/9/29
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Parexel enters definitive agreement to acquire ExecuPharmUS-based Parexel, one of the world's biggest contract research organisations, has entered a definitive agreement to purchase ExecuPharm for an undisclosed amount. Headquartered in US and established2016/9/28
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Pharmaron to acquire Merck Sharpe & Dohme's Hoddesdon research facility in UKPharmaron has signed a non-binding heads of terms with Merck Sharpe & Dohme Limited (MSD) for the purchase of UK-based Hoddesdon site, which comprises MSD’s process development and research facili2016/9/28
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Allele receives NIH grant to develop new antibody therapy for Alzheimer’s diseaseAllele Biotechnology and Pharmaceuticals (Allele) has secured a grant from the US National Institutes of Health's (NIH) National Institute on Aging to develop a new antibody therapy for Alzheimer’s di2016/9/27
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US FDA accepts Sanofi and Regeneron’s dupilumab BLA for priority reviewThe US Food and Drug Administration (FDA) has granted priority review status to Sanofi and Regeneron’s biologics license application (BLA) for dupilumab to treat adult patients with inadequately contr2016/9/27
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US FDA grants approval for Novartis' Ilaris to treat Periodic Fever SyndromesNovartis has received the US Food and Drug Administration's (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions. Periodic Fever Syndromes are a group of diseases2016/9/26
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Report: Favourable market environment to drive Australian pharmaceutical industry to $25bn by 2020Good market access and government’s welfare reforms such as subsidies for prescription drugs are expected to drive the pharmaceutical market in Australia to $25bn in value by 2020, according to a repo2016/9/26
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EC grants marketing authorisation for Aptalis’s Truberzi to treat IBS-DThe European Commission (EC) has granted marketing authorisation for Aptalis’s Truberzi (eluxadoline) in Europe. Rights to the drug will shortly be transferred back to Allergan, following thesale of2016/9/23
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Sanaria receives FDA fast-track designation for malaria vaccineSanaria has received fast-track designation from the US Food and Drug Administration (FDA) for candidate malaria vaccine PfSPZ. PfSPZ is currently in clinical trials that are intended to finalise an2016/9/23
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Gilead faces another bid for hep C royalties as U of MN sues for patent infringementThe University of Minnesota wants a piece of Gilead Sciences’ megablockbuster hepatitis C business. The school sued Gilead for patent infringement Monday, claiming that the drugmaker’s sofosbuvir-bas2016/9/22