PharmTech Europe News

The directorate highlights its 2016 achievements.

Takeda inaugurated expanded capacity of solid-dosage drugs at its site in Oranienburg, Germany.

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.

By purchasing the BMS Sword, Ireland facility, SK Biotek will be the first South Korean company to invest in pharmaceutical manufacturing in Ireland.

The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

A recent meeting emphasized the need for more guidance and flexibility from regulators, as well as harmonization, standards and equipment interoperability.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.

Germany-based Grünenthal will gain rights to market and sell Zomig (zolmitriptan) outside of Japan. 

The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.

Takeda will build a new production facility at its existing Grange Castle site in Ireland.

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

The agency published an action plan to nurture innovation and drug development by SMEs.

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The company expanded its UK storage facility to meet increasing demand from its growing customer base.

Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.  

Aptar Pharma’s e-Lockout device uses advanced electronic technology to limit the number of doses available during a 24-hour period, thereby ensuring safe patient compliance to Takeda’s pain-relieving nasal spray.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.

The agency released its report on pilot project to involve patients in the assessment of medicines.

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

The pharmaceutical market in Spain is showing signs of stability according to a report by GlobalData.

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward.

On April 24, 2017, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a group of executives from several big pharma companies composed an open letter to the European Medicines Agency (EMA) regarding its relocation.