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

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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