With re­lo­ca­tion vote loom­ing, the EMA is open­ly fret­ting as cities jock­ey for at­ten­tion

The biggest de­ci­sion that the EMA faces has noth­ing to do with any drug an­gling for a Eu­ro­pean ap­proval or how it’s do­ing rel­a­tive to the FDA in pro­vid­ing ef­fi­cient prod­uct re­views. In 10 days the EU will vote on which of the 19 prospec­tive cities will win the right to host the agency in one of the most hot­ly con­test­ed com­pe­ti­tions to come out of the UK’s vote in fa­vor of Brex­it.

The win­ner will im­me­di­ate­ly get the full at­ten­tion of the lead­ers of the EMA, who have a list of de­mands ready to go.

In this case, though, the Lon­don-based or­ga­ni­za­tion now re­sid­ing on Ca­nary Wharf is ab­solute­ly pow­er­less. So it’s been do­ing the on­ly thing it’s able to do — fu­ri­ous­ly flag­ging in­ter­nal fears that a po­lit­i­cal de­ci­sion will force them in­to some back­wa­ter lo­ca­tion in East­ern Eu­rope with­out a suit­able place to do gov­ern­ment busi­ness.

From their state­ment Wednes­day:

The most press­ing is­sue that needs the im­me­di­ate at­ten­tion of EMA and the host coun­try is the Agency’s new premis­es.

Just fit­ting out its new head­quar­ters will take 12 to 15 months, says the EMA. Build­ing one in time will re­quire fast ac­tion and a hur­ry-up con­struc­tion sched­ule. Up to 900 house­holds will have to be moved — un­less the EU goes with an un­wel­come lo­ca­tion, in which case a ma­jor­i­ty of the EMA’s staff say they’ll just find oth­er jobs.

And school­ing for hun­dreds of their chil­dren? That all has to start be­ing sort­ed out in a mat­ter of months.

The EMA has made its pref­er­ences clear, rank­ing all 19 cities from A — with Am­s­ter­dam in the top 5 — to Z; for Za­greb in the bot­tom five.

What will the EU do? No one re­al­ly knows, giv­en the rules around the No­vem­ber 20 bal­lot. And that like­ly isn’t help­ing mat­ters in­side a jit­tery EMA.

“It’ll be a blood­bath,” one anony­mous se­nior diplo­mat told Reuters. “Every­one will be fight­ing their cor­ner. It will have noth­ing to do with the mer­its of these cities.”

Brent Saun­ders

That won’t calm any fears at the EMA. But this is one de­bate where every­one has a strong opin­ion.

Al­ler­gan CEO Brent Saun­ders, for ex­am­ple, is do­ing what he can this week to steer the EMA to Dublin — a rather weak num­ber 9 on the EMA’s list. Al­ler­gan is based in Ire­land pri­mar­i­ly for tax rea­sons, along with a num­ber of oth­er bio­phar­ma com­pa­nies, but that doesn’t make Saun­ders’ list of every­thing the coun­try has go­ing for it.

We chose Ire­land as our home be­cause of its com­mit­ment to sci­en­tif­ic ad­vance­ment, its tech-savvy work­force, gov­ern­ment in­tegri­ty, qual­i­ty of life, com­mit­ment to the Eu­ro­pean Union and ex­cel­lent air­line con­nec­tions to Eu­rope and Amer­i­ca.

And be­sides, every­one speaks Eng­lish and you can hop on a flight to Lon­don al­most any­time.

We’ll know in 10 days just how im­por­tant that is to the EU.


Im­age: The EMA’s cur­rent HQ in Lon­don’s Ca­nary Wharf Shut­ter­stock

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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