CRO Medpace has tripled the size of its Stirling, Scotland office with a new office, also in Stirling, that will allow for growth in data management, biostatistics, quality assurance, regulatory affairs, clinical operations and safety services.
The Government of India will now defer EU trade negotiations as part of its effort to support local CRO GVK Biosciences, which was accused of data manipulation by the EMA (European Medicines Agency).
A confidential information exchange agreement will strengthen the relationship between the EMA and Swiss regulators and could save on resources, the agencies say.
Companies that recommission old single-use devices would have the same liability as the original device maker under draft guidelines proposed by the MHRA.
The latest EMA (European Medicines Agency) report on GCP (good clinical practice) inspections reveals that deficiencies around SOPs (standard operating procedures), sponsor monitoring, data management, and essential documents linked to trials were most...
US and China-based CRO FMD K&L has expanded into Armenia with a new office to support clients’ needs in the region and grow the company’s business further in Europe.
Proposed amendments to TTIP backed by MEPs will either encourage foreign investment or allow US drug firms to sue EU states whose laws restrict profits, depending who you ask.
The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU.
Europeans who want to fund organised crime can now do so more easily by buying medicines from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.
Industry efforts set up a drug database to help Europeans identify fake pharmaceuticals progressed this week after thee software firms signed development deals with project leader, EMVO.
Health Action International (HAI) has set up an office in Brussels, Belgium in a bid to further influence European pharmaceutical policy and improve access to medicines and public health.
Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.
Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.
Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.
European drug industry groups have contrasted 'misguided' cuts to the Horizon 2020 budget with US plans to increase NIH funding for science R&D under the 21st Century Cures Bill.
Replacing animal studies in drug development is impossible according to the European Commission, which has rejected a petition calling for a ban signed by 1.2m people.
The proportion of pediatric trials of all clinical trials in the EU continues to increase since the integration of a Pediatric regulation in 2007, despite a decrease in the number of clinical trials overall since then, according to a new report from the...
Merck KGaA is confident it will close the $17bn acquisition of Sigma-Aldrich in mid-2015 despite competition concerns from the European Commission (EC).
Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK Biosciences...
EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.
Schott, Heuft and GEA have teamed up to offer drugmakers a serialisation service for primary packaging to help with EU anti-counterfeiting requirements.
Understanding international regulatory demands, manufacturing standards and overcoming cultural barriers are key for Asian drugmakers looking to enter Western markets, says market access CRO ELC Group.
A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.
The European Investment Bank (EIB) has loaned Innocoll AG €25m to support development of a post-surgical painkiller and diabetes-related infection drug delivered using its collagen-based tech.
With operations across 19 European countries as well as the US, contract Research Organization KCR recently relocated its head office from Warsaw, Poland, to Berlin, Germany to be closer to clients.
In order to close Novartis’ $16bn purchase of GlaxoSmithKline’s portfolio of cancer treatments, the FTC (Federal Trade Commission) is requiring Novartis to divest all assets related to its potential BRAF and MEK inhibitor drugs to settle anticompetitive...
The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.
The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.
Following Wockhardt’s decision to cease supplying APIs to the EU market, the UK drug regulator MHRA (Medicines and Healthcare Products Regulatory Agency) has updated its statement of noncompliance to include all APIs made from the India-based manufacturer.
Sweden’s pharmaceutical regulator is pushing hard to make water pollution regulations a binding part of GMP, and says “embarrassed” European agencies are dragging their feet more than big pharma.
US package delivery giant UPS has announced it will buy Polish healthcare logistics firm Poltraf SP zoo from private equity fund Ortie Capital Investment.
British Airways and Iberia’s cargo division IAG has become the first airline to be awarded accreditation under new EU Good Distribution Practices (GDP) guidelines.
European CRO KCR has acquired a portfolio of clinical projects from the Ukrainian CRO Axis Group thereby making the country the most important location for KCR in the region of the Commonwealth of Independent States (CIS).
GVK Biosciences has called marketing authorisation withdrawals by various European regulators “disproportionate,” arguing that ECG results at centre of data manipulation investigation have no bearing on safety.
DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.
After much discussion and some confusion, the ICH’s (International Conference on Harmonization) Q3D guideline, which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.
