No­var­tis cuts 275 jobs at Illi­nois site to con­sol­i­date Zol­gens­ma man­u­fac­tur­ing in North Car­oli­na

As No­var­tis con­tin­ues to re­shape it­self, the com­pa­ny is shut­ting the doors to one of its gene ther­a­py man­u­fac­tur­ing sites in the US.

The clo­sure of a site in Lib­er­tyville, IL, a city to the north­east of Chica­go, fol­lows a “com­pre­hen­sive man­u­fac­tur­ing site net­work eval­u­a­tion,” the com­pa­ny said in a state­ment to End­points News.

The de­ci­sion will cause 275 jobs to be axed, but the site is ex­pect­ed to re­main op­er­a­tional through the end of next year, with some ac­tiv­i­ties stop­ping ear­li­er as oth­ers will take time to com­plete. The com­pa­ny will of­fer 90-day no­ti­fi­ca­tions to work­ers along with sev­er­ance pack­ages, out­place­ment sup­port and oth­er ben­e­fits.

 Aa No­var­tis spokesper­son added:

Op­er­a­tions to make, test and re­lease Zol­gens­ma will be con­sol­i­dat­ed to the Durham, North Car­oli­na fa­cil­i­ty, which al­so cur­rent­ly pro­duces Zol­gens­ma. Gene ther­a­pies and ad­vanced plat­forms are still ex­pect­ed to play an in­creas­ing­ly im­por­tant role in the years and decades to come at No­var­tis. How­ev­er, our most re­cent net­work as­sess­ment, along with clar­i­fied de­mand ex­pec­ta­tions and high­er yields through process im­prove­ments, show that we can meet cur­rent and an­tic­i­pat­ed glob­al de­mand for Zol­gens­ma and fu­ture gene ther­a­pies through a sin­gle site.

This is not the on­ly move that No­var­tis is mak­ing in terms of trim­ming down its sites and staff. The Swiss phar­ma will cut around 400 jobs at its cam­pus in Dublin by the end of 2024 as part of wider cuts that are a part of a ma­jor re­struc­tur­ing that the com­pa­ny kicked off in April.

Al­so, as No­var­tis is plan­ning to spin out San­doz in the near fu­ture, the gener­ic com­pa­ny shut­tered an oral sol­id dosage plant in Wil­son, NC, which made tablets and cap­sules for Cana­da and the US and em­ployed about 246 peo­ple.

San­doz is al­so in­vest­ing €50 mil­lion ($50.3 mil­lion) in­to in­creas­ing its man­u­fac­tur­ing ca­pac­i­ty for fin­ished dos­es of peni­cillin in Eu­rope at its site in Kundl, Aus­tria. This will come on the backs of a €100 mil­lion in­vest­ment in­to new tech­nol­o­gy to pro­duce in­gre­di­ents for oral amox­i­cillin at the Kundl site.

Richard Saynor

“An­tibi­otics re­main the back­bone of mod­ern med­i­cine and we are see­ing rapid­ly in­creas­ing de­mand fol­low­ing the un­prece­dent­ed mar­ket swings of the past few years. This in­vest­ment will help to meet that grow­ing pa­tient need, to sup­port the cre­ation of hun­dreds of new jobs, and to par­tial­ly off­set the im­pact of high en­er­gy prices by low­er­ing unit costs,” said San­doz CEO Richard Saynor, in a state­ment.

This comes as a short­age of amox­i­cillin has been re­port­ed by San­doz and sev­er­al oth­er man­u­fac­tur­ers, with the com­pa­ny stat­ing it is see­ing an in­crease in de­mand for the drug.

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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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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Credit: Shutterstock

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.

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.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

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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