BMS, rendition of the new site in Leiden, Netherlands

Bris­tol My­ers finds a home for 1st EU cell ther­a­py site, clear­ing land near Am­s­ter­dam air­port for easy lo­gis­tics

As Bris­tol My­ers Squibb con­tin­ues to scale its CAR-T op­er­a­tions, the New York drug gi­ant will open up its first cell man­u­fac­tur­ing site in Eu­rope — and it’s tapped space near the Am­s­ter­dam air­port as its home.

The com­pa­ny is set to build a new cell ther­a­py site in Lei­den and lever­age the life sci­ences com­mu­ni­ty near the air­port for con­ve­nient ac­cess for ship­ping pa­tient cells. Fi­nan­cial terms were not dis­closed.

BMS is rapid­ly ex­pand­ing its man­u­fac­tur­ing ca­pa­bil­i­ties fol­low­ing the ap­proval of Abec­ma, the first BC­MA CAR-T ther­a­py. The drug was co-de­vel­oped with blue­bird and has a list price of $419,500. That nod made Bris­tol My­ers the first and on­ly with two ap­proved CAR-T cell ther­a­pies — CD19 and BC­MA. Mean­while, the drug­mak­er’s sci­en­tists are work­ing on on­col­o­gy treat­ments for large B cell lym­phoma and mul­ti­ple myelo­ma.

Ann Lee

The Lei­den fa­cil­i­ty is the com­pa­ny’s fifth fa­cil­i­ty of its kind, but it’s the first in Eu­rope. SVP Ann Lee said in a state­ment that sev­er­al hun­dred peo­ple are ex­pect­ed to be hired at the lo­ca­tion.

“A key el­e­ment of BMS’ com­mit­ment to cell ther­a­py is our con­tin­u­ous in­vest­ment in ad­vanced man­u­fac­tur­ing ca­pa­bil­i­ties, from the ex­pan­sion of our glob­al net­work and ca­pac­i­ty to treat pa­tients to re­duced turn around time and op­ti­mized costs,” she said.

Gilead — whose sub­sidiary Kite de­vel­oped CAR-T  Yescar­ta — al­so has a site in the Nether­lands.

Pa­tients’ own cells are sent from the man­u­fac­tur­ing fa­cil­i­ty to a treat­ment cen­ter, and then mon­i­tored for weeks to en­sure there are no neg­a­tive re­ac­tions. Be­cause of that, close prox­im­i­ty to trans­porta­tion is key in en­sur­ing re­duced ship­ping time, BMS said in an email to End­points News. The site in Lei­den is near the Nether­lands’ two largest cities — Rot­ter­dam and Am­s­ter­dam — and will help cut down on that trans­porta­tion time.

The Eu­ro­pean ex­pan­sion is BMS’ sec­ond scale-up an­nounced this week. Tues­day, news broke that the com­pa­ny ex­pand­ed its al­ready-ex­ist­ing lease at Cam­bridge Cross­ing near Boston to con­tin­ue con­sol­i­dat­ing its R&D ops in the area. The move will merge all of its Boston-area staff un­der the same roof in a new state-of-the-art cam­pus that will al­so be oc­cu­pied by at least three oth­er biotechs.

Con­struc­tion in Eu­rope is set to be­gin lat­er this year, and site plan­ning and de­vel­op­ment are un­der­way. The com­pa­ny al­so has cell ther­a­py sites in Both­ell, WA; and War­ren and Sum­mit, NJ, and teams with con­tract part­ners in the EU and Japan. In March, the com­pa­ny an­nounced it would build a mas­sive 244,000-square-foot cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty at its De­vens, MA site.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.