PharmTech Europe News

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?

The Wellcome Global Monitor has demonstrated an overall positive trust in science but some concerns still remain on attitudes on vaccines.

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

CHMP has recommended that the indication of Victoza (liraglutide) be extended to include its use in pediatric patients with Type 2 diabetes.

ABPI and BIA have issued responses to the recently published governmental guidance on European Union exit preparedness.

During its biannual meeting in Amsterdam, ICH approved four new regulatory observers and reviewed the progress made on global harmonization efforts.

CMA has issued a statement of objections provisionally finding that four pharmaceutical companies have broken competition law.

IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.

Be The Match BioTherapies and TrakCel have announced a collaboration to provide integrated solutions for companies developing cell and gene therapies.

Biotech company Genmab signed an agreement with Johnson & Johson’s Janssen Biotech to develop a monoclonal antibody product using Genmab’s HexaBody technology.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

New CDMO facility supports early-stage API manufacturing and scale up.

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.

GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.

Sphere Fluidics has secured a total of $4.8 million (£3.7 million) in investment after closing its additional tranche investment work $2.9 million (£2.2 million).

ABPI has published a guide for pharmaceutical companies on how to work successfully, collaboratively, and ethically with patients and patient groups, in line with the ABPI Code of Practice.

Dassault Systèmes, a provider of virtual universes to imagine sustainable innovations, has signed a definitive agreement to acquire Medidata Solutions in an all-cash transaction.

Recently presented and published study results have demonstrated the ability of AstraZeneca’s Farxiga on reducing the progression of kidney disease or renal death in type-2 diabetes.

OGT has announced the expansion of its SureSeq portfolio with a complete library preparation solution for hybridization-based target capture in NGS.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO in Philadelphia.

Biotage has announced a strategic collaboration with Shandong Yingsheng Biotechnology for the development of clinical MS applications in China.

ERS Genomics and Bioneer have revealed the signing of a license agreement for access to CRISPR/Cas9 genome editing technology intellectual property.

European midmarket private equity group, Duke Street, has agreed to acquire Kent Pharmaceuticals and Athlone Laboratories from DCC Vital.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.