PharmTech Europe News

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

Two of the medicines recommended for approval are orphan drugs.

EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.

The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.

The agency has published a continuity plan for its move from the United Kingdom.

Europe updates the guideline on excipients information in labeling and packaging.

Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.

The company has extended its presence in the US market to support its growing business in the region.

Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

Xellia Pharmaceuticals completed the expansion of its laboratory services building at its Budapest manufacturing site.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

ipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

The new system will help accelerate the commercialization of Aston Particle Technologies’ dry particle coating technology.

GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.

Intertek seeks to bring cost efficiencies to the pharmaceutical supply chain through confidential shared audits.

The agency is asking the public to share their experiences with the drug so EMA can determine its safety.

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

Fresenius Kabi has added two new antibiotics production lines at its plant in Santiago de Besteiros, Portugal.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.