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Taking stock on the ‘big-ticket’ news items, both good and bad, from the past 12 months.
Editor's note: This article appears in the December 2018 issue of Pharmaceutical Technology Europe.
As everything starts slowing down ready for the holidays, it’s time to take stock on the major happenings within pharma from the past 12 months. In an effort to provide a brief review for you, I have formed a small list of the ‘the good, the bad, and the Brexit’ news items from the year. For details on these news stories, see www.PharmTech.com.
This year has seen numerous drug approvals both in Europe and in the United States. The story that probably hit most headlines was Novartis receiving European approval for Kymriah, in August, representing the first in Europe for a chimeric antigen receptor T cell therapy. Another first for Europe was seen in April when Mylan and Biocon received marketing authorization for biosimilar insulin glargine (Semglee) from the European Commission.
In manufacturing news, the first continuous powder processing plant of its kind opened at the University of Sheffield in April, aimed at future-proofing the solid-dosage manufacturing talent pool. Additionally, the European Union strengthened its pan-Pacific relationship with Japan on GMP inspections.
Also, at CPhI Worldwide in Madrid, Spain, the industry recognized outstanding achievements with the CPhI Pharma Awards.
Early in the year, we learned that Martin Shkreli would serve seven years in prison (1), but the ‘Pharma Bro’ wasn’t the only one in the legal hot-seat. Recently, London-based ITH Pharma was charged with offences related to the deaths and serious infections of babies.
There has also been the serious, and ongoing case, of impurities found in valsartan-the active ingredient of multiple blood-pressure drugs. Both the US FDA and the European Medicines Agency (EMA), as well as regional regulators, are taking active measures to determine the extent of the nitrosamine contamination and potential impact on patient safety.
Undeniably, Brexit has been a hot topic of the year. Early on, EMA announced its relocation from London to Amsterdam, incurred significant job losses as a result-a topic of discussion by Sean Milmo in this month’s EU Regulatory Watch column.
Most recently, everyone within Europe has been on tenterhooks waiting to see if an agreement on a withdrawal deal can be reached. If ‘no-deal’ is the final outcome, the ramifications could be widespread and would impact the pharma sector significantly, which Lynne Byers of NSF International discussed in detail (2).
When reviewing the stories from the year, even though I have only managed to mention a fraction here, it is clear that despite the lows there have also been significant highs, particularly the number of approvals worldwide. As we enter 2019, I shall look forward to covering the important industry news to help keep you abreast of the latest developments. Until then, I wish you all a happy and safe festive season.
1. The Independent, “Martin Shkreli Sentenced to Seven Years in Prison for Securities Fraud and Defrauding Investors,” independent.co.uk, 9 March 2018.
2. PharmTech, “Prioritising Pragmatism in Face of a ‘no-deal’ Brexit,” pharmtech.com, 20 November 2018.
Pharmaceutical Technology Europe
Vol. 30, No. 12
When referring to this article, please cite it as F. Thomas, “The Good, The Bad, and The Brexit," Pharmaceutical Technology Europe 30 (12) 2018.