Regulatory Index News w/c 25 February 2019

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


Gene therapy progress spurs Sarepta buy of Myonexus

An experimental gene therapy showed early signs of working in three patients with limb-girdle muscular dystrophy, spurring increased expression of a crucial protein missing in individuals with the rare, genetic neuromuscular disorder.

To read more follow this BioPharmaDive link


Lusutrombopag gets EU green light for liver disease

The European Commission (EC) has granted marketing approval for Shionogi’s lusutrombopag, for the treatment of severe thrombocytopaenia in adults with chronic liver disease (CLD), who are undergoing invasive procedures.

To read more follow this PharmaTimes link


Lynparza successful in pancreatic cancer trial

AstraZeneca and MSD have announced positive results from the Phase III POLO trial, in which there was a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with Lynparza (olaparib) for pancreatic cancer, making it the first PARP inhibitor to demonstrate benefit in the disease.

To read more follow this PharmaTimes link


Amgen wins jury verdict in PCSK9 court battle with Sanofi, Regeneron

A federal jury on Monday upheld the validity of two patents held by Amgen on antibodies that work similarly to its cholesterol drug Repatha, setting back the rival team of Sanofi and Regeneron for the second time in a long-running court fight.

To read more follow this BioPharmaDive link


In front of Congress, pharma execs blame 'broken' system

Pharma executives testifying Tuesday in front of the Senate Finance Committee stuck to a familiar script on drug pricing, criticizing the current system as "unsustainable" while highlighting the growing separation between the prices drugmakers set and the prices net of rebates and discounts provided to insurers.

To read more follow this BioPharmaDive link


Darolutamide’s FDA rolling submission completed

Orion and Bayer have completed a rolling submission of a New Drug Application (NDA) for darolutamide to the US Food and Drug Administration (FDA).

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

28th February 2019

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