BioPharm International Editors

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring.

More favourable conditions for the pharmaceutical industry, including a "golden era of renewed productivity and prosperity" have been forecast in a new report from analyst firm PricewaterhouseCoopers (PwC).

The European Commission (EC) has issued final approval for Europe’s first gene therapy; a treatment for a rare genetic disorder that currently has no other treatment options.

USP revises labeling requirements for Heparin.

GlaxoSmithKline (GSK) has outlined the measures it is taking as part of a new open innovation approach to R&D, including opening up its tuberculosis compound library, investing in its open laboratory in Spain, and sharing detailed clinical trial data with researchers.

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.

The European Medicines Agency (EMA) has abolished its Cell-based Product Working Party (CPWP) and Gene Therapy Working Party (GTWP), with the aim of improving efficiencies and optimising the use of available expertise.

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicoloured brain that appeared on the company’s website for the diagnostic PET tracer, Amyvid.

USP Hosts Symposium on Science and Standards

Merck KGaA has announced plans to eliminate 1100 jobs in Germany by the end of 2015—almost 10% of the company's 10,900 German positions.

The European Medicines Agency has launched a public consultation concerning its inventory of paediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

AstraZeneca has paid approximately $3.2 billion to extend its diabetes alliance with Bristol-Myers Squibb (BMS), following BMS’s recently completed acquisition of Amylin Pharmaceuticals.

Novartis has entered into a global collaboration with the University of Pennsylvania in the US to research, develop and commercialise targeted cancer therapies.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European-Union customs in 2011.

The UK's Medicines and Healthcare products Regulatory Agency has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials.

The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

The European Federation of Pharmaceutical Industries and Associations has called for the German government to take "urgent action" regarding its pricing system, which is perceived as hindering the market entry of new, innovative medicines in the country.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity-Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the launch of a EUR 223.7-million ($276.5 million) program to tackle antimicrobial resistance and speed up the development of new antibiotics.

The US Pharmacopeia has issued a third round of improvements to its blood thinner standard

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has formally adopted a memorandum of understanding (MoU) with key partners for a harmonised, European system for medicines verification.

The UK's Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county's supply chain.

GlaxoSmithKline has partnered with Yale University to design a potential new class of medicines that could be beneficial in areas such as oncology, inflammation, and infection.

The European Commission is offering a EUR 2-million ($2.64 million) inducement prize to encourage innovation in the area of cold-chain logistics and vaccine stability.

The Management Board of the European Medicines Agency (EMA) has introduced a range of new measures to strengthen and extend its conflicts of interest (COI) policy for scientific-committee members and experts, as well as for members of the management board.