PharmTech Europe News

Researchers who are younger than 35 years with an advanced degree and working within Europe will be able to apply for the award.

As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.

This pharma insight briefing from Agilent Technologies will cover the application of Raman and infrared spectroscopy for pharmaceutical quality control (QC).

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

Vetter chose a winner from four teams that worked for three months to develop ideas for applying digital technology to injectable pharmaceuticals.

The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.

The company plans to lay off approximately 400 employees to support the restructuring of its R&D organization.

The National Institute for Health and Care Excellence recently rejected National Health Service’s funding of Kymriah for diffuse large B-cell lymphoma (DLBCL) despite recognizing that the drug has significant clinical benefits.

Finalists for the CPhI 2018 Pharma Awards, taking place on Oct. 9, 2018 in Madrid, have been announced.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.

The company will showcase the evolving role of vitamins and lipid APIs in pharmaceutical applications at CPhI Worldwide 2018.

The European Medicines Agency has recommended Luxturna (voretigene neparvovec) as the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene.

The agreement now includes 15 European Union (EU) member states.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year project for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

Evonik completed a EUR 36 million expansion of its contract-manufacturing capabilities for API and advanced intermediates in the United States and Germany.

On Wednesday, Oct. 9, 2018, Dr. Caroline Bauer will discuss selecting technologies that enable the progression of compounds that require bioavailability enhancement to achieve target absorption at CPhI Worldwide.

Researchers from Ruhr-Universität Bochum in Germany and the National Institutes of Health modified the protein Nurr1 to enter cells from the outside, possibly enabling the protein to become a drug development candidate for illnesses such as Parkinson’s disease.

Gerresheimer started producing its Gx RTF ClearJect cyclo-olefin copolymer syringes in Germany and will exhibit at CPhI WorldWide 2018.

The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.

The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.

Pharma packaging manufacturer Sanner has expanded capacity at its site in Budapest, Hungary.

The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

The recommended drugs include two orphan medicines and three biosimilars.