Rahul Singhvi, Resilience CEO (Business Wire)

Re­silience pur­chas­es Ohio bio­man­u­fac­tur­ing site from As­traZeneca

Biotech man­u­fac­tur­ing pi­o­neer Re­silience said Tues­day af­ter­noon that it is pur­chas­ing an Ohio-based man­u­fac­tur­ing site from As­traZeneca and build­ing a new part­ner­ship with the UK-based phar­ma.

The fa­cil­i­ty is based in the town of West Chester, OH, just north of Cincin­nati. Re­silience will pro­duce “se­lect” As­traZeneca med­i­cines at the fa­cil­i­ty as part of the sup­ply agree­ment. The fi­nan­cial terms of the agree­ment weren’t dis­closed, but the deal is ex­pect­ed to close ear­ly next year.

By ac­quir­ing the West Chester plant, Re­silience will get all the site’s phys­i­cal as­sets, re­tain its lead­er­ship and around 500 em­ploy­ees, and plan to in­vest in the work­force and the wider fa­cil­i­ty.

The site it­self is around 580,000 square feet and is equipped with many man­u­fac­tur­ing ca­pa­bil­i­ties, in­clud­ing asep­tic fill­ing, in­spec­tion, pack­ag­ing, cold-chain op­er­a­tions, au­toin­jec­tors, and a vir­tu­al re­al­i­ty train­ing cen­ter.

“We en­vi­sion the West Chester site as our glob­al cen­ter of ex­cel­lence for com­mer­cial drug prod­uct man­u­fac­tur­ing that will pro­duce a wide range of life-sav­ing med­i­cines,” said Re­silience CEO Rahul Singhvi in a state­ment.

Re­silience and As­traZeneca al­so an­nounced on Tues­day that both com­pa­nies will es­tab­lish a long-term bio­man­u­fac­tur­ing re­la­tion­ship to sup­port As­traZeneca’s port­fo­lio, with As­traZeneca gain­ing ac­cess to Re­silience’s end-to-end man­u­fac­tur­ing ser­vices.

The ad­di­tion of the West Chester site now gives Re­silience close to two mil­lion square feet of bio­man­u­fac­tur­ing space.

And this move al­so comes dur­ing a pe­ri­od of rapid ex­pan­sion for Re­silience. Af­ter grab­bing $625 mil­lion in Se­ries D fi­nanc­ing this sum­mer, the com­pa­ny quick­ly inked deals with MD An­der­son and the Mayo Clin­ic to es­tab­lish man­u­fac­tur­ing op­er­a­tions at the med­ical cen­ters to try and quick­ly turn around the pro­duc­tion of ther­a­pies.

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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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.

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.

Charles Riv­er se­cures $50M ac­qui­si­tion of drug dis­cov­ery tech com­pa­ny

Over the past several years, Massachusetts-based contractor Charles River Laboratories has been busy on the M&A front, with the latest, $50 million buyout coming Monday for a provider of high-throughput screening solutions for discovery research.

Chicago-based SAMDI Tech will now be folded into Charles River’s discovery and safety assessment division, Charles River announced.

The $50 million in cash is for the 80% of SAMDI that Charles River didn’t previously own. Other financial details on the deal were not disclosed.

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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