PharmTech Europe News

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

BD’s new high-tech manufacturing facility in Zaragoza, Spain, will create up to 600 jobs by 2030.

The expansion in Le Mans, France will support growth in clinical and commercial manufacturing.

The expansions will add peptide manufacturing capacity.

NIH reported that an investigational gene therapy developed by researchers from the University of California, Los Angeles and Great Ormond Street Hospital in London can restore the immune systems of infants and children who have severe combined immunodeficiency due to adenosine deaminase deficiency.

The collaboration, which has been in place since 1998, will focus on drug discovery, translational medicine research, and pharmaceutical development.

Lonza plans to invest approximately CHF 850 million (US$936 million) to build new state-of-the-art mammalian manufacturing facilities at its Visp, Switzerland, and Portsmouth, NH, sites.

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

Researchers from the United Kingdom, have identified a new additive manufacturing method that enables the 3D printing of medicine in highly porous structures.

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

Solentim has announced the expansion of its European operations, with the establishment of a new entity in Ireland.

Vectura and Inspira Pharmaceuticals have joined forces to develop a potential inhaled therapy for COVID-19.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

The world of bio/pharma has been celebrating its achievements across a variety of categories in the latest rounds of awards.

The UK’s Medicines and Healthcare products Regulatory Agency has granted an approval for Vazkepa (icosapent ethyl) to be used as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients in Great Britain.

The European Medicines Agency and the European Centre for Disease Prevention have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide room for future small-molecule technologies expansion.

EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.

Phico Therapeutics has been awarded up to $18.2 million in grant funding from the CARB-X partnership to advance its lead antibacterial therapy.

Adaptate Biotherapeutics has raised a further $18 million in equity investment during a Series A2 funding round.

Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.

The new facility, which will be Evotec’s first in Europe, will aim to offer capacity, flexibility, and quality for biotherapeutic development and manufacturing while utilizing technology that employs small, automated, highly intensified, and continuous bioprocessing operations inside autonomous cleanrooms.

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

BMS has announced that the EC has approved Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma.

EMA's Pharmacovigilance Risk Assessment Committee is reviewing very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.

EMA is continuing to monitor the incidences of very rare blood clots with low blood platelets occurring after vaccination with the AstraZeneca COVID-19 vaccine (Vaxzevria).