It is imperative to understand the various regulatory variations globally, develop a strategy for new technologies, engage in harmonization activities, and implement risk management measures.
In what was reported as an "unprecedented backlash," trade groups representing U.K. drugmakers - as well as four other industries - for the first time expressed concerns about a possible Brexit deal, having previously been more concerned about a possible no-deal Brexit.
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Bayer said Monday that the European Medicines Agency had approved Vitrakvi for NTRK fusion-positive cancers. The drug won U.S. Food and Drug Administration accelerated approval in November.
The company said it would withdraw the application for Xyndari after a negative opinion from the EMA's Committee for Medicinal Products for Human Use, which had ruled against the drug in May. The FDA approved the drug under the brand name Endari in 2017.
An analyst wrote that bluebird bio would likely launch Zynteglo first in Germany, followed by other countries, but scaled back sales forecasts due to the therapy's high price tag of 1.575 million euros.
The biotech company said it would price Zynteglo for beta-thalassemia at about $1.8 million for the European market. Data for the therapy in that disease and also sickle cell disease are being presented at EHA.
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The rules are still more restrictive than the European Medicines Agency's, which allow national governments to determine interchangeability. The FDA would require additional testing to demonstrate products can be freely substituted like generic pharmaceuticals.
Nikkei Asian Review reported that the company would cover some or all the cost of the therapy, Alofisel, which won EMA approval last year, if it did not provide benefit. The UK's NICE has declined to recommend it, citing modest benefit in a clinical trial.
The planned withdrawal follows the January failure of a Phase III trial to back up the study used for Lartruvo's accelerated approval. Following the announcement, the FDA and EMA recommended no new patients receive the drug.
The EMA's Committee for Human Medicinal Products recommended a conditional approval for Zynteglo in beta-thalassemia. A third-party press release erroneously stated the agency had approved the product earlier this week.
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Two beta-thalassemia advocacy organizations - one British and one Italian - issued a press release Monday that claimed the EMA had approved the gene therapy under the brand name Zynteglo.
The Swiss drugmaker is concerned that a no-deal Brexit would disrupt delicate supply chains and urged the UK and EU to provide clarity in order to minimize disruptions.
The agreement would have allowed UK pharmaceutical regulations to remain under EMA authority after Brexit. Uncertainty around the planned withdrawal has caused worry in the life sciences sector.
A number of scenarios could indeed diminish the UK's attractiveness, but it is likely to remain an important player, with a lot riding on the future regulatory regime.
Ian Hudson, CEO of the MHRA, will step down in September 2019. He cited the country's withdrawal from the European Union as a key factor.