Novartis bags US okay for Lucentis follow-up Beovu in wet AMD

is starting to see its growth tail off. ... leader – as well as off-label use of Roche’s Avastin (bevacizumab) and patent expiries looming in the US next year and in 2022 in Europe.

Insys gets bankruptcy court okay for Subsys sale

Earlier this year, five former Insys executives including founder and chairman John Kapoor were convicted of racketeering conspiracy after being found guilty of encouraging widespread, off-label use of the product ... market the drug for use in its

Insmed claims first FDA okay for limited population antibiotic

We estimate that as many as 10, 000 to 15, 000 of NTM MAC patients in the US fail treatment, when using the off-label antibiotic regimen that is the current ... Despite the limited patient population, analysts have predicted that Arikayce could become a

EU’s 10-year paediatric meds report - not bad, but can do better

Measures to promote the testing of medicines in paediatric patients have resulted in a significant reduction in the off-label use of adult medicines in children, says the European Commission. ... These include “off-label use of products designed for

Are rare disease companies naturally more patient-centric?

The starting point for this development pathway is usually off label use, where doctors have been confronted with a difficult patient with very little hope of a true diagnosis or suitable

Healthcare systems

The gold standard of scientific evidence

More than one in five prescriptions in the United States are for an off-label use; providing additional evidence to better understand treatment efficacy and safety is crucial. ... A path forward. Real-world evidence is already in use around the world.

Does safety sell medicines?

New legislation in Europe introduced in 2012 has also led companies to expand what they collect from just side effects to reports of occupational exposure, off-label use and medication errors. ... Through the collection and review of adverse event

Pharma deals during February 2013

Merck &Co has also returned to the biosimilar race following its exit from the Enbrel development programme after Amgen settled an off-label use case for Aranesp in December 2012. This ... Pharma will contribute 300 compounds and the remaining 200 will

Changes to pharmacovigilance legislation in Europe

of the marketing authorisation (off-label use), as well as the misuse and abuse of the medicinal product. . ... More generally, the competent authority may lay down 'any other conditions or restrictions with regard to the safe and effective use of the

"Legal highs" ruling leaves illegal labs laughing

This could explain the popularity of Bake Off and the reason so many Brits seem addicted to cake.  . ... There is a huge amount of off-label use of licensed medicines by medically qualified prescribers.