Regulatory Index News w/c 22 April 2019

Here is a selection of this week's news from around the world


527,000 UK children unvaccinated with first measles dose in 2010–17

A recent survey conducted by Unicef has found that between 2010 and 2017, 527,000 – over half a million – children were not vaccinated in the UK with the first dose of the measles vaccine.

To read more follow this PharmaTimes link


Another late-stage miss knocks Gilead from its leading NASH position

Gilead's most advanced drug for non-alcoholic steatohepatitis, a fatty liver disease better known as NASH, has failed a second late-stage clinical trial, arguably costing the big biotech a leading position in the field.

To read more follow this BioPharmaDive link


Lilly to withdraw FDA-approved cancer drug after clinical failure

Eli Lilly on Thursday said it is working to pull its cancer medicine Lartruvo from global markets, about three months after the pharma disclosed the drug failed a Phase 3 study

To read more follow this BioPharmaDive link


FDA orphan drug designation granted for Autolus’ acute lymphoblastic leukemia drug

Autolus Theraputics has announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to its acute lymphoblastic leukemia (ALL) treatment.

To read more follow this PharmaTimes link


New research could spot people most susceptible to infection after knee replacement surgery

New research funded by the National Institute for Health Research (NIHR) has identified which groups of people are most likely to develop a severe infection after knee replacement surgery and therefore need the joint replacement redone.

To read more follow this PharmaTimes link


Keytruda approved in kidney cancer, challenging Bristol-Myers

Merck & Co. looks set to challenge Bristol-Myers Squibb in yet another cancer immunotherapy indication, announcing Monday the U.S. approval of its checkpoint inhibitor Keytruda together with Pfizer's Inlyta for patients with advanced kidney cancer. 

To read more follows this BioPharmaDive link




Lorna Osborn

Date Published

26th April 2019

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