A week ago, Re­car­dio an­nounced it would cut UK tri­al sites out of its up­com­ing heart drug study cit­ing Brex­it fears that quick­ly re­ver­ber­at­ed across the in­dus­try. It turns out that the lit­tle biotech was mere­ly fol­low­ing a trend that al­ready emerged last year.

In 2017, a to­tal of 597 tri­als were launched in Britain — 25% low­er than the av­er­age be­tween 2009-16, ac­cord­ing to an analy­sis by Fitch. In those eight years, the av­er­age num­ber of new clin­i­cal tri­als was 806.

Sheuli Porkess

In light of the UK’s im­pend­ing de­par­ture from the Eu­ro­pean Union — and in prepa­ra­tion for a worst case no-deal sce­nario — drug­mak­ers in­clud­ing As­traZeneca, Sanofi and No­vo Nordisk have be­gun stock­pil­ing drugs to al­le­vi­ate the im­pact of a pos­si­ble in­ter­rup­tion in drug sup­plies. But con­cerns about how the EMA, soon to be re­lo­cat­ed from Lon­don to Am­s­ter­dam, will han­dle clin­i­cal tri­al da­ta from the UK are rel­a­tive­ly new and could spell longterm trou­ble for the R&D hub.

“We know from our mem­bers that Brex­it-re­lat­ed un­cer­tain­ty is a ma­jor con­cern when it comes to de­ci­sions about whether to set up tri­als in the NHS,” Sheuli Porkess, deputy chief sci­en­tif­ic of­fi­cer at the As­so­ci­a­tion of the British Phar­ma­ceu­ti­cal In­dus­try, told Reuters. “This is why it’s vi­tal that we get a Brex­it deal to keep the in­vest­ment and skills in clin­i­cal tri­als here in the UK.”

Though Par­lia­ment vot­ed in Ju­ly to make it a ne­go­ti­at­ing ob­jec­tive for the UK gov­ern­ment to seek its par­tic­i­pa­tion in the Eu­ro­pean med­i­cines reg­u­la­to­ry net­work, with ne­go­ti­a­tions be­tween Lon­don and Brus­sels still shroud­ed in un­cer­tain­ty, there’s lit­tle clue how — or whether — that would hap­pen.

The Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency, for­mer­ly an af­fil­i­ate of the EMA, will like­ly be­come the coun­try’s top drug reg­u­la­tor post-Brex­it. The de­gree of in­ter­ac­tion it will have with the Eu­ro­pean sys­tem re­mains to be seen.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.