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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

Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns

Restrictions placed on the use of Gedeon Richter’s uterine fibroid drug Esmya by the European Medicines Agency could significantly dent the product’s sales in the EU, and could also have a knock-on effect in the US, where the FDA accepted an NDA filing for the drug in October 2017.

Drug Safety Drug Review

Richter’s Uterine Fibroid Drug Esmya Hit By Liver Safety Concerns In EU

EU safety restrictions relating to liver toxicity concerns are likely to lead to changes to the labeling of Richter’s uterine fibroid product Esmya and to a sharp drop in the product’s sales. The moves could also affect the product in the US, where it was filed for approval last year.

Drug Safety Europe

UK Patent ‘Plausibility’: Landmark Lyrica Case May Get Supreme Court Ruling By Early Summer

Companies looking forward to a ruling from the Supreme Court on “plausibility” in the UK case involving second medical use patents may have to wait until May or June.

Intellectual Property United Kingdom

EU Advocate General Sides With Pfizer Over Orifarm’s Parallel Importing Of Enbrel

An advocate general of the Court of Justice of the EU has given an opinion in the case of Pfizer v Orifarm that, if followed by the full court, will clarify the scope of the “specific mechanism” that was introduced to give patent holders protection against parallel imports from the acceding member states between 2004 and 2013.

Intellectual Property Europe

Agree A Brexit Transition By March Or See Pharma Waste Money On Contingency Plans, Says UK Cttee

UK health secretary Jeremy Hunt has been told by the Commons health committee that the government must agree a Brexit transition period that preserves the “regulatory status quo,” otherwise companies will be forced to start spending money on contingency planning that may prove unnecessary.

Brexit Regulation

New EU Submissions For Pfizer’s Lorlatinib, Teva’s Fremanezumab - And A CV Filing For Canakinumab

New products submitted for evaluation by the European Medicines Agency include Pfizer’s lorlatinib for lung cancer, Teva’s fremanezumab for migraine, and Shionogi’s lusutrombopag for thrombocytopenia. An already authorized drug, Novartis’s canakinumab, has been filed for a new use: reduction of cardiovascular risk.

Drug Review Approvals
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