EMA warns HQ move may cause ma­jor tur­moil, se­ri­ous­ly de­lay­ing new drug ap­provals

The Eu­ro­pean Med­i­cines Agency on Tues­day warned that it could lose a ma­jor­i­ty of its staff based on which of the 19 cities vy­ing to host the med­i­cines reg­u­la­tor is se­lect­ed by the Eu­ro­pean Coun­cil in No­vem­ber, threat­en­ing the pace of new drug ap­provals even in best-case sce­nar­ios for at least two years.

Based on the re­sults of a sur­vey com­plet­ed by 92% of EMA’s staff ear­li­er this month, the agency says it could lose be­tween 19% and 94% of its staff de­pend­ing on which city is se­lect­ed as its fu­ture host. Politi­co first re­port­ed that Am­s­ter­dam is the top choice among EMA staff.

Af­ter Am­s­ter­dam, just three ad­di­tion­al un­named cities are pro­ject­ed to pro­vide enough cov­er to main­tain the reg­u­la­tor’s ba­sic safe­ty mon­i­tor­ing mis­sion.  “For cer­tain lo­ca­tions staff re­ten­tion rates could be sig­nif­i­cant­ly less than 30% [re­ten­tion]. This would mean that the Agency is no longer able to func­tion and, as there is no back­up, this would have im­por­tant con­se­quences for pub­lic health in the EU,” the EMA says.

The Eu­ro­pean Com­mis­sion is ex­pect­ed the com­plete its as­sess­ment of the 19 of­fi­cial of­fers to host EMA in the next few days. And, fol­low­ing a po­lit­i­cal dis­cus­sion in Oc­to­ber, the 27 EU mem­ber states, mi­nus the UK, will vote on the agency’s fu­ture lo­ca­tion at the EU Gen­er­al Af­fairs Coun­cil meet­ing in No­vem­ber.

For the sur­vey, EMA staff were asked to rate how like­ly they were to stay with the agency for each of the 19 can­di­date cities. EMA then took the re­sults of the sur­vey and di­vid­ed the cities in­to four groups based on the lev­el of ex­pect­ed em­ploy­ee re­ten­tion.

Five cities fell in group 1 with 65% or greater em­ploy­ee re­ten­tion, an­oth­er five fell in group 2 with a 50-65% re­ten­tion rate, one city fell in group 3 with a 30-50% re­ten­tion rate and eight cities fell in group 4 with a less than 30% re­ten­tion rate.

While the sur­vey re­port does not iden­ti­fy the cities by name, EMA says the re­sults re­flect staff mem­bers’ per­son­al as­sess­ments of whether the can­di­date cities meet their needs based on the in­for­ma­tion pre­sent­ed in the cities’ of­fi­cial bids and staff mem­bers’ own re­search in­to the lo­ca­tions.

Ac­cord­ing to EMA, the agency needs at least 462 full-time equiv­a­lent em­ploy­ees to per­form its high­est pri­or­i­ty ac­tiv­i­ties, which in­clude as­sess­ing new drugs and safe­ty mon­i­tor­ing, and an­oth­er 140 FTEs to han­dle medi­um pri­or­i­ty pub­lic health ac­tiv­i­ties, such as curb­ing an­timi­cro­bial re­sis­tance and work­ing with health tech­nol­o­gy as­sess­ment bod­ies. An ad­di­tion­al 110 FTEs are need­ed for low­er pri­or­i­ty ac­tiv­i­ties, such as cor­po­rate gov­er­nance, au­dits and ad­min­is­tra­tive sup­port.

With those re­quire­ments, on­ly four cities would like­ly re­tain enough staff to per­form EMA’s high­est pri­or­i­ty ac­tiv­i­ties, and no cities would ful­ly meet the agency’s staffing needs for medi­um and low pri­or­i­ty ac­tiv­i­ties with­out ad­di­tion­al re­cruit­ment.

Even in the best case sce­nar­ios, EMA says to ex­pect de­lays in ap­prov­ing new med­i­cines and slowed progress on oth­er pub­lic health ini­tia­tives for the next two to three years.

In the worst cas­es, EMA says it would be “un­able to op­er­ate” and the EU and mem­ber states would need to im­ple­ment emer­gency mea­sures to pro­tect pub­lic health, such as re­ly­ing on third coun­tries for ap­proval de­ci­sions.

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.

Im­age: EMA’s cur­rent head­quar­ters in Lon­don. Shut­ter­stock

BREAK­ING: Mer­ck makes a triple play on Covid-19: buy­ing out a vac­cine biotech, part­ner­ing on an­oth­er pro­gram and adding an an­tivi­ral to the mix

Merck is making a triple play in a sudden leap into the R&D campaign against Covid-19.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

The deal with IAVI covers recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s successful Ebola Zaire virus vaccine. That’s going into the clinic later this year.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.

Andrew Hopkins, Exscientia founder and CEO (Exscientia)

Af­ter years of part­ner­ships, AI biotech Ex­sci­en­tia lands first ma­jor fi­nanc­ing round at $60M

After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.