Drop in clin­i­cal tri­al num­bers un­der­scores drug­mak­er­s' fears over Brex­it that trace back over a year

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

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.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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