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Executive Editor, Pharma Insights
UK
38+ years of experience
Scrip
By Ian Schofield 29 Nov 2022
Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year.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
Generics Bulletin
By Ian Schofield 11 Jun 2021
As part of its drive to maximize global access to coronavirus vaccines, the Medicines Patent Pool has developed a publicly accessible resource giving information on the patent status of approved and candidate vaccines.
Pink Sheet
By Ian Schofield 08 Apr 2021
The team behind Sputnik V has attacked what it calls “fake news and provocations” in the EU as political arguments over the vaccine claim another ministerial scalp.
Pink Sheet
By Ian Schofield 27 Jan 2021
Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.
Topic Brexit Pharma-Brexit
Pink Sheet
By Ian Schofield 27 Jan 2021
There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.
Topic Regulation Brexit Pharma-Brexit
Pink Sheet
By Ian Schofield 27 Nov 2020
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
Topic Pharma-Brexit Brexit Regulation
Generics Bulletin
By Ian Schofield 27 Nov 2020
A second wave of COVID-19 infection later this year would put even greater pressure on drugs used in patients hospitalized with serious respiratory problems, a new report warns.
Topic Coronavirus Distribution
Pink Sheet
By Ian Schofield 27 Nov 2020
Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.
Topic Pharma-Brexit Brexit EU
Medtech Insight
By Ian Schofield 27 Nov 2020
As negotiators struggle to reach agreement on the future UK/EU relationship following Brexit, suppliers have been warned to expect major hold-ups next year for medical products crossing the English Channel.
Pink Sheet
By Ian Schofield 27 Nov 2020
Could the UK carry on playing a part in the European Medicines Agency from 2021? Much will depend on the complex negotiations on the future relationship that are expected to kick off in March.
Pink Sheet
By Ian Schofield 23 Nov 2020
From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
Topic EU Pharma-Brexit Brexit
Pink Sheet
By Ian Schofield 23 Nov 2020
The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year.
Topic Pharma-Brexit Brexit Approvals
Pink Sheet
By Ian Schofield 17 Nov 2020
Following a Brexit-induced delay over the summer, England's HTA body NICE has come up with a concrete set of proposals that it says will help it “robustly and efficiently” evaluate innovative technologies such as advanced therapies, histology-independent cancer treatments, and technologies for rare diseases. Industry bodies have welcomed the plans, which have just been put out for consultation.
Pink Sheet
By Ian Schofield 29 Oct 2020
Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period
Topic Pharma-Brexit Rare Diseases
Pink Sheet
By Ian Schofield 29 Oct 2020
Proposals from NICE now under consultation are intended to boost the health technology assessment body’s efficiency, improve transparency and governance, and raise the quality of its guidance
Topic Regulation EU
Pink Sheet
15 Jul 2022
Pink Sheet
15 Jul 2022
Pink Sheet
13 Jul 2022
Pink Sheet
13 Jul 2022
Medtech Insight
13 Jul 2022
Pink Sheet
12 Jul 2022
Pink Sheet
12 Jul 2022
Pink Sheet
11 Jul 2022
Pink Sheet
08 Jul 2022
Pink Sheet
07 Jul 2022
Pink Sheet
01 Jul 2022
Pink Sheet
30 Jun 2022
Pink Sheet
29 Jun 2022
Pink Sheet
28 Jun 2022
Pink Sheet
27 Jun 2022
