Skip to NavigationSkip to content

Manufacturing and Production

THE ORPHAN DRUGS & RARE DISEASES CONFERENCE

Top Ten most popular articles on Pharmafile.com this week

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.

EU approval for Roche's Polivy combo in relapsed/refractory B-cell lymphoma

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

Janssen’s ulcerative colitis medicine not recommended by NICE for use in adults

NICE has published draft guidance which does not recommend Stelara (ustekinumab) for treating moderately to severely active ulcerative colitis in adults, due to concerns about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 Pharma's Sunosi becomes first EU-approved drug of its kind in narcolepsy and sleep apnoea

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.

Cardiff University team discovers new method of killing cancers

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.

Novartis' Mayzent granted license by the European Medicines Agency

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.

Collaborating to realise the potential of precision medicine

Published on 20/01/20 at 11:38am

Healthcare is an evolving continuum, and while traditional strategies have seen improvements to patient outcomes over time, voices in the industry have been calling ever louder for a more targeted approach over the past decade. Collaboration may just be the key to make this shift a reality, as Matt Fellows discovers.

Ipsen appoints new Exec VP and Chief Medical Officer

Published on: 17/01/20

Ipsen has named Dr Steven Hildemann as its new Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Pharmacovigilance.

In his new role, which begins on 1 March 2020 and will be based in Paris, he will report directly to Ipsen CEO Aymeric Le Chatelier. His remit will include the provision of medical strategy to the company’s scientific, clinical and business teams, while also working in tandem with its R&D operations to design and direct clinical trials efforts to generation of post-launch data.

Top Ten most popular articles on Pharmafile.com this week

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.

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches