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Executive Editor, Pharma Insights
UK
+34 year(s) experience
Having graduated in modern languages at the University of Bath in 1979, he worked in the European travel industry before joining Scrip World Pharmaceutical News as a reporter in 1985, covering the French and Italian markets. He later became Deputy Editor with responsibility for EU regulatory affairs, a post he held until 2005 when he took on the role of Consultant Editor to a number of Informa publications including Scrip and the Regulatory Affairs Journal.
In July 2008 Ian became a Principal Analyst for Informa Business Information, covering global regulatory and legal issues in areas such as clinical trials, biosimilars, orphan drugs, and pricing and reimbursement. As well as writing news, features and analysis for Scrip Intelligence, Scrip Regulatory Affairs, the Pink Sheet and In Vivo, Ian is part of the Ask the Analyst team that produces on-demand tailored reports for subscribers.
Pink Sheet
By Ian Schofield 10 Jan 2019
New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Topic Drug approval Drug review
Pink Sheet
By Ian Schofield 18 Oct 2018
Companies wanting to compete in the newly off-patent adalimumab market in England have until Oct. 22 to submit their bids. They will need to offer “competitive prices” if they are to secure the highest share of sales to the national health service. At the same time, NHS trusts and clinical commissioning groups have been warned not to accept discounted interim offers from suppliers keen to get a foot in the door.
Pink Sheet
By Ian Schofield 22 Aug 2018
Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.
Pink Sheet
By Ian Schofield 22 Aug 2018
A pilot project run by the European Pharmacopoeia is being expanded in an effort to produce general quality standards for monoclonal antibodies, following the adoption of a monograph for infliximab last November.
Scrip
By Ian Schofield 15 May 2018
Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year. But the mCRC withdrawal is likely to have limited commercial impact and the company is more interested in pursuing the product’s use in combination treatment for this indication.
Topic Cancer
Pink Sheet
By Ian Schofield 18 Jan 2018
A study to look at the factors that determine the uptake of biosimilars has been launched by the Finnish regulator.
Topic Biosimilars
Pink Sheet
By Ian Schofield 29 Nov 2017
The EMA has produced further guidance for pharmaceutical companies on the changes they will need to make as a result of Brexit
Topic Brexit
Pink Sheet
By Ian Schofield 16 Nov 2017
In the run-up to next Monday’s vote on the EMA’s future home, political horse-trading and vote-swapping behind the scenes.
Topic Brexit
Pink Sheet
By Ian Schofield 27 Oct 2017
The European Medicines Agency has published more than 3,000 clinical documents on 50 individual medicines since its policy on the proactive publication of clinical data came into effect in October 2016.
Topic Clinical trials
Pink Sheet
By Ian Schofield 18 Oct 2017
“Vaccine hesitancy” – the gradual decline in rates of vaccination against preventable diseases – has led to outbreaks of illnesses
Topic Vaccines
Pink Sheet
By Ian Schofield 31 Aug 2017
Recent evidence indicates that using DAAs together with warfarin, a vitamin K antagonist, may result in changes in the INR.
Topic Drug review
Pink Sheet
By Ian Schofield 23 Aug 2017
A position paper from the UK government has laid out some ideas for ensuring a smooth transition to a post-Brexit world in the area of regulation.
Topic Brexit
Pink Sheet
By Ian Schofield 10 Aug 2017
Some countries in eastern Europe say that they should host the European Medicines Agency in order to respect the criterion of “geographical spread.”
Topic Brexit
Pink Sheet
By Ian Schofield 03 Aug 2017
Some regulatory activities have been on hold at the European Medicines Agency as it prepares for the impact of the UK’s departure from the EU.
Pink Sheet
By Ian Schofield 17 Jul 2017
Dublin will “absolutely” meet the criteria for hosting the European Medicines Agency.
Topic Biosimilars
Pink Sheet
16 Jan 2019
Pink Sheet
15 Jan 2019
Pink Sheet
14 Jan 2019
Pink Sheet
11 Jan 2019
Pink Sheet
09 Jan 2019
Scrip
09 Jan 2019
Pink Sheet
09 Jan 2019
Pink Sheet
07 Jan 2019
Pink Sheet
04 Jan 2019
Pink Sheet
03 Jan 2019
Pink Sheet
02 Jan 2019
Pink Sheet
31 Dec 2018
Pink Sheet
27 Dec 2018
Pink Sheet
21 Dec 2018
Pink Sheet
20 Dec 2018
