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Ian Schofield

Edinburgh, U.K
Ian Schofield has been writing on issues affecting the pharmaceutical and biotech industry since the mid-1980s, specialising in EU and global policy and regulatory affairs.  As well as writing, editing and commissioning articles for Pharma Intelligence, Ian works for the Ask the Analyst service, providing tailor-made answers to questions posed directly by clients. He has a degree in modern languages from the University of Bath. Outside the realm of work, Ian plays guitar in a traditional music group and also enjoys a touch of cycling and gardening. He lives by the seaside about three miles from the centre of Edinburgh.
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Latest From Ian Schofield

New Patents Database To Help Countries Improve Medicines Procurement

The international drug industry group, IFPMA, the World Intellectual Property Organization and 20 big pharmas have launched Pat-INFORMED, a new patent database that can be used by governments to improve their medicines procurement programs. The R&D-based industry says it clearly links public patent information to registered medicines in a new, user-friendly online gateway. However, the European generics industry body Medicines For Europe says the move amounts to "patent linkage" and will have anti-competitive effects for generics firms. 

Emerging Markets Generic Drugs

Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

English Court Queries EMA Primacy & Says Avastin Can Be Used In AMD

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

Reimbursement Regulation

Dutch Insurer Seeks €4m from AZ Over ‘High’ Seroquel Price

AstraZeneca is being pursued in court for compensation over what a health insurer calls the “unnecessarily high price” that the company charged for Seroquel.

Pricing Debate Reimbursement

UK Court Opens Way To Generic Versions Of Gilead’s Truvada

The High Court has ruled that Gilead’s supplementary protection certificate on Truvada is invalid, opening the way to generic versions of the combination drug for preventing HIV infection.

 

Intellectual Property United Kingdom

CHMP Preview: Lilly, Merck and Bayer Hopeful On Approvals; Sarepta’s Exondys Appeal Result Due

The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.

Europe Drug Review
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