EMA to lose 25% of staff as hard Brex­it ap­proach­es

As UK Prime Min­is­ter There­sa May’s Brex­it deal is ex­pect­ed to be re­ject­ed Tues­day in a House of Com­mons vote, the EMA has said that af­ter close­ly mon­i­tor­ing staffers’ in­ten­tions to re­lo­cate to Am­s­ter­dam, it cur­rent­ly ex­pects a staff loss of about 25%.

The 25% fig­ure might seem like a lot of staffers to lose (about 225 of 900 lost), but that fig­ure is on the low end of pre­dic­tions from a sur­vey in Sep­tem­ber 2017 that found EMA ex­pect­ed to lose at least 19% of its staffers no mat­ter which city was se­lect­ed.

In ad­di­tion to the staffing loss­es, EMA said it will fur­ther tem­porar­i­ly re­duce or sus­pend ac­tiv­i­ties in the first half of 2019 as it moves in­to the fi­nal phase of its phys­i­cal re­lo­ca­tion. EMA said it will launch such mea­sures as part of a fourth and fi­nal phase of the busi­ness con­ti­nu­ity plan as of 1 Jan­u­ary.

For in­stance, be­tween 11 Feb­ru­ary and 15 March 2019, no pre-sub­mis­sion meet­ings for ini­tial mar­ket­ing au­tho­riza­tion ap­pli­ca­tions will take place, while EMA moves to its new premis­es. EMA will al­so not print or dis­patch cer­tifi­cates for phar­ma­ceu­ti­cal prod­ucts from 25 Feb­ru­ary un­til 14 March 2019, though com­pa­nies can still sub­mit re­quests dur­ing this pe­ri­od, which EMA will con­tin­ue to process.

“Tem­po­rary sus­pen­sion and scal­ing back of ac­tiv­i­ties is cur­rent­ly sched­uled to last un­til 30 June 2019. Cur­rent staffing pro­jec­tions should al­low EMA to grad­u­al­ly re­sume these ac­tiv­i­ties as of Ju­ly 2019. EMA will re­view this in April 2019, once it has moved to its tem­po­rary build­ing in Am­s­ter­dam,” EMA said.

And staff re­lo­ca­tion to the per­ma­nent build­ing is slat­ed to be fi­nal­ized by 31 De­cem­ber 2019.

The agency said that de­spite the halt­ing of cer­tain ac­tiv­i­ties, it ex­pects all core ac­tiv­i­ties re­lat­ed to the eval­u­a­tion and su­per­vi­sion of med­i­cines “to con­tin­ue with­out any in­ter­rup­tion or de­lays fore­seen and to the same qual­i­ty.”

The agency al­so said it will pro­vide more in­for­ma­tion on this fourth phase of the con­ti­nu­ity plan and its ac­tiv­i­ties dur­ing this crit­i­cal pe­ri­od short­ly.

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.

Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.