PharmTech Europe News

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

The medical cannabis producer has become compliant with EMA’s GMP standards.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

The company will begin trials with its CBD chewing gum, CanChew Plus, for the treatment of irritable bowel syndrome.

The agency published an overview of marketing authorizations made in 2016.

Luke Miels will replace Abbas Mussain as president of GSK’s Global Pharmaceutical division later this year.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

The company opened a facility in Spain dedicated to the production of meglumine.

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.

As Europe’s bio/pharma market learns that breaking up is hard to do, it also must address productivity, regulatory, and drug pricing challenges.

A pilot project, beginning in 2017, will support the development of biosimilars.

The agency announces that 81 medicines overall were recommended in 2016.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

The UK’s NICE recommended pembrolizumab for the treatment of patients with advanced lung cancer, reversing the institute’s earlier decision.

Recipharm and Laccure AB signed a commercial collaboration for the manufacture and delivery of Laccure’s bacterial vaginosis treatment.

Vetter’s Ravensburg data processing center received certification from a German industrial testing organization, certifying that the company’s customer and process data are protected.

Europe-based bio/pharma employees are unified on satisfaction with employment conditions-and dissatisfaction with salaries.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

Spanish CRO, Kymos Pharma Services, announced that it has acquired Pharmaprogress, an Italian firm based in Ancona, specializing in contract research and analysis services.

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

British artificial intelligence company BenevolentAI has signed an exclusive license for a series of novel clinical-stage drug candidates with Johnson & Johnson.

Researchers in the University of Dundee have discovered a new method of activating drugs to combat visceral leishmaniasis. The discovery could lead to better treatments for neglected tropical diseases.

The new facility will focus on formulation development, drug product analytical development, and quality control.

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.

Bellicum and Ospedale Pediatrico Bambino Gesù will collaborate on preclinical and clinical development of CAR-T and TCR therapeutics.

TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.