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AstraZeneca’s Lumoxiti secures FDA nod to treat hairy cell leukaemiaAstraZeneca and its research and development arm MedImmune have obtained approval from the US Food and Drug Administration (FDA) for the use of Lumoxiti to treat adults with relapsed or refractory hai2018/9/19
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CRISPR, ViaCyte team up to develop stem cell therapies for diabetesSwiss gene editing company CRISPR Therapeutics and US-based regenerative medicine firm ViaCyte have formed a strategic alliance to discover, develop and commercialise stem cell therapies for diabetes2018/9/19
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EMA and FDA find additional impurity in valsartan productsThe European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have reported the presence of a second impurity in valsartan products. The new impurity is called N-Nitrosodiethylami2018/9/18
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Allergan to buy neurotoxins firm Bonti for $195mAllergan has entered an agreement to acquire biotechnology company Bonti for an upfront payment of $195m along with other potentialcommercial milestone-based payments. Bonti primarily develops and co2018/9/18
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NIH’s new initiative to boost cures for sickle cell diseaseThe National Institutes of Health (NIH) has launched a new initiative to expedite the development of genetic therapies to treat sickle cell disease. The Cure Sickle Cell Initiative will leverage new2018/9/17
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Shire gets marketing clearance for Veyvondi in EuropeIrish biotechnology firm Shire has secured authorisation from the European Commission (EC) to market Veyvondi for the treatment of adults with von Willebrand disease (VWD). The drug is indicated for2018/9/17
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NICE rejects NHS use of Roche’s Ocrevus for PPMSIn its final draft guidance, the UK’s pricing regulator the National Institute of Health and Care Excellence (NICE) has not recommended Roche’s Ocrevus (ocrelizumab) for routine National Health Servic2018/9/14
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UK researchers develop non-antibiotic drug for tuberculosisResearchers at the University of Manchester have formulated a non-antibiotic drug for the treatment of infection caused by Mycobacterium tuberculosis bacteria (MptpB), including antibiotic resistant s2018/9/14
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Janssen’s Invokana and Vokanamet receive expanded labelling in EuropeThe European Commission (EC) has approved expanded labelling of Janssen Pharmaceutical’s Invokana and Vokanamet to include positive cardiovascular outcomes. Invokana (canagliflozin) obtained the Euro2018/9/13
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FDA seeks more clinical data on GSK’s mepolizumab for COPDThe US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to GlaxoSmithKline (GSK)’s application for approval of its pulmonary drug mepolizumab to treat chronic obstructive2018/9/13