PharmTech Europe News

Under an Innovate UK grant for a three-year project, Arcinova and the University of Nottingham will develop a continuous, flexible modular manufacturing technology platform.

A new report gives an overview of the work of the International API Inspection Program.

This workshop, to be held in Sheffield, United Kingdom, on June 7, 2018, will provide an introduction to the use of glass as primary pharmaceutical packaging.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

The contract service provider will invest in a laboratory expansion at its site located in Tredegar, Wales, UK.

The new premises have been built-to-spec to offer efficient, high quality, and environmentally friendly service to customers.

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

Emerson will provide Ireland’s National Institute of Bioprocessing Research and Training with technologies to help the institute prepare students for the transition to manufacturing digitization in the biopharmaceutical industry.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

Nanologica AB has entered into a service agreement with CDMO Sterling Pharma Solutions for the large-scale production of silica particles.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

The government is exploring terms by which the UK could still be part of EMA after its departure from the EU, Theresa May said in a key speech on Brexit.

GlaxoSmithKline has issued a voluntary recall of three lots of respiratory inhalers in the United Kingdom, including preventer and emergency relief inhalers.

Fluarix Tetra has been approved for use in children aged six months and above.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

The Awards honor innovations in drug delivery and packaging, for better patient safety and compliance.

The agency met to discuss its new temporary and permanent premises in Amsterdam.

EMA will be using temporary premises in the city while construction of the new building takes place, which is not ideal because it requires moving the agency's headquarters twice.

The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

Brexit-related challenges cast shadows on prospects for the European bio/pharma market in 2018, but optimism may let some sun shine through.

EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.

The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.

The agency and the European Commission published updated guidance to answer questions about Brexit.

During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.