Manufacturing and Production

Indian pharmaceutical firms received more than double the amount of warning letters in the first ten months of 2019, compared with 2018, while Pakistan has registered cases against 200 pharmaceutical companies as it cracks down on illict pratices.

Also in the news, a team at Cardiff University have discovered a new part of the human immune system that could be harnessed to kill prostate, breast, lung and other cancers in lab tests.

The European Commission has awarded conditional marketing approval to Roche’s Polivy (polatuzumab vedotin), it has been revealed.

NICE has published draft guidance which does not recommend Stelara (ustekinumab) for treating moderately to severely active ulcerative colitis in adults, due to concerns about cost-effectiveness.

Stelara would have been given when conventional therapy or a biological agent could nnot be tolerated or the disease responded inadequately or lost response to treatment.

Jazz Pharmaceuticals has secured approval from the European Commission for Sunosi (solriamfetol), it has emerged, as a therapy to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) or narcolepsy with or without cataplexy.

The indication relates to patients whose EDS has not been effectively tackled by primary OSA therapy. It marks the first licensed dual-acting dopamine and norepinephrine reuptake inhibitor approved in Europe for this indication.

A team at Cardiff University have discovered a new part of the human immune system that could be harnessed to kill prostate, breast, lung and other cancers in lab tests.

The findings were published in Nature Immunology. It has not yet been tested in human patients but the researchers feel optimistic about its potential.

The European Medicines Agency (EMA) has granted a licence for the use of Mayzent (siponimod) in the treatment of certain adults with secondary progressive multiple sclerosis (SPMS).

Mayzent is a tablet that is taken daily, and is the first oral disease-modifying treatment for patients with an active disease.

The EMA granted the license based on Phase 3 data from the EXPAND trial. The drug was found to delay disease progression, slow the advance of physical symptoms and positively impact cognition in a broad SPMS patient population.

Pakistan is cracking down on corruption and has registered cases against 200 pharmaceutical companies, while in the US the FDA has move to authorise Blueprint Medicines’ kinase inhibitor Ayvakit (avapritinib) for the treatment of unresectable or metastatic gastrointestinal stromal tumours.

In Europe, Sanofi has revealed that the European Commission has expanded the existing label for Toujeo to include the treatment of children and adolescent patients with diabetes.