EMA says sym­bol­ic good­bye to Lon­don HQ as it sets up shop in Am­s­ter­dam

Eu­rope’s med­i­cines reg­u­la­tor, hav­ing been based in Lon­don since 1995, is gear­ing up for its move to Am­s­ter­dam as West­min­ster’s un­cer­tain­ty re­gard­ing Brex­it shows no signs of abat­ing and drug­mak­ers is­sue warn­ings about the dis­rup­tion to drug sup­plies.

The de­ci­sion to move the Eu­ro­pean drug watch­dog was trig­gered by Britain’s 2016 de­ci­sion to leave the EU. In No­vem­ber 2017, Am­s­ter­dam was cho­sen as the EMA’s new home by EU mem­ber states, which bode well for staff who re­port­ed­ly in a sur­vey put the city at the top of the list of places they would fol­low the agency to.

How­ev­er, the EMA ex­pects about 25% of its 900 em­ploy­ees to leave as it makes the move, the agency said in an an­nounce­ment last week. “We are al­ready con­duct­ing a mas­sive pro­gramme for re­cruit­ment so that we can re­place staff who might choose not to fol­low the Agency; we have re­ceived and screened over 5,000 ap­pli­ca­tions for the var­i­ous po­si­tions we have ad­ver­tised,” a spokesper­son for the reg­u­la­tor told End­points News.

EMA is set to leave its premis­es at Lon­don’s Ca­nary Wharf on 1 March 2019. Last Fri­day, a pri­vate cer­e­mo­ny for staff was held to sym­bol­i­cal­ly say good­bye to the of­fice at the British cap­i­tal.

From 4 to 8 March, the agency will op­er­ate on the ba­sis of ex­tend­ed tele­work­ing, it said. Dur­ing this week a small num­ber of staff will be present in the new tem­po­rary build­ing, the Spark build­ing in Am­s­ter­dam Slo­ter­dijk, to deal with any po­ten­tial emer­gen­cies. Be­tween 11-15 March EMA staff will grad­u­al­ly move in­to the build­ing.

“Whilst re­lo­cat­ing…the fo­cus will be on the au­tho­ri­sa­tion, main­te­nance and su­per­vi­sion of med­i­cines, on­go­ing Brex­it pre­pared­ness/im­ple­men­ta­tion ac­tiv­i­ties and prepar­ing for the im­ple­men­ta­tion of the new vet­eri­nary leg­is­la­tion,” the spokesper­son added. EMA’s new per­ma­nent head­quar­ters, a tai­lor-made build­ing in the Zuidas busi­ness dis­trict of Am­s­ter­dam, are planned for com­ple­tion in No­vem­ber 2019, but from 4 March on­wards it will be con­sid­ered the agency’s of­fi­cial ad­dress.

Mean­while, it looks like Britain is set to leave the EU on March 29, with or with­out a deal.

Im­age: EMA

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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A new Genentech 'MS Visibility' campaign video features Black women living with or connected to MS talking about their experiences. (Genentech)

Roche’s Genen­tech de­buts next it­er­a­tion of MS cam­paign, high­lights ex­pe­ri­ences in Black com­mu­ni­ty

Roche’s Genentech is tackling diversity in multiple sclerosis again, this time with a focus on the Black community. Its “MS Visibility” effort, debuted in 2021, is now adding to the awareness campaign with new work that includes a set of videos featuring discussions among Black women and healthcare professionals.

“They’re incredibly inspiring Black women living with or connected to MS and they’re having just honest conversation about their experience and the unique barriers that their community faces,” said Jennifer Kim, head of neuroimmunology at Genentech marketing.

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