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Executive Editor, Pharma Insights
UK
+34 year(s) experience
Pink Sheet
By Ian Schofield 23 Jan 2019
The BioIndustry Association wants the government to rule out a “no-deal” Brexit, saying it would be bad for patients and the life sciences sector.
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Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year.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
22 Mar 2019
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20 Mar 2019
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19 Mar 2019
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18 Mar 2019
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15 Mar 2019
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14 Mar 2019
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13 Mar 2019
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13 Mar 2019
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12 Mar 2019
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11 Mar 2019
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11 Mar 2019
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08 Mar 2019
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06 Mar 2019
Pink Sheet
05 Mar 2019
Pink Sheet
04 Mar 2019
