WuXi of­fi­cial­ly opens cell and gene ther­a­py site in Philly; An­oth­er mas­sive man­u­fac­tur­ing site comes to NC

A new cell and gene ther­a­py test­ing fa­cil­i­ty in Philadel­phia’s Navy Yard is of­fi­cial­ly opened, WuXi ATU an­nounced Mon­day.

The new fa­cil­i­ty in­cludes 140,000 square feet worth of lab­o­ra­to­ries, and will en­hance the com­pa­ny’s con­tract test­ing, de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion busi­ness mod­el by tripling the com­pa­ny’s pre­vi­ous ca­pac­i­ty.

The move helps strength­en the ex­ist­ing test­ing ca­pac­i­ty and ca­pa­bil­i­ty, and com­bines the com­pa­ny’s pow­er­ful test­ing ca­pa­bil­i­ties with its ad­vanced ther­a­pies’ process de­vel­op­ment and man­u­fac­tur­ing plat­forms, such as TES­SA tech­nol­o­gy for AAV man­u­fac­tur­ing and XLen­ti sta­ble so­lu­tions for lentivi­ral man­u­fac­tur­ing, it says in a press re­lease.

“WuXi ATU has al­ways been at the fore­front of in­no­va­tion in Philadel­phia,” said Kate Mc­Na­ma­ra, the SVP of the Philadel­phia In­dus­tri­al De­vel­op­ment Cor­po­ra­tion, Naval Yard site. “We are thrilled to cel­e­brate their con­tin­ued ex­pan­sion and growth with the open­ing of the new ad­vanced ther­a­pies test­ing fa­cil­i­ty at the Navy Yard.”

An­oth­er mas­sive man­u­fac­tur­ing site comes to NC

The Alexan­dria Re­al Es­tate group an­nounced that it will make a push to bring R&D and “next-gen man­u­fac­tur­ing” to North Car­oli­na’s Re­search Tri­an­gle through part­ner­ships with top-tier biotechs through a se­ries of ac­qui­si­tions.

Most no­tably, the com­pa­ny bought up a 95 acre par­cel on Corn­wal­lis Road to build the Alexan­dria Cen­ter for NextGen Med­i­cines, and is in the per­mit­ting phase for a 125,000-square-foot site.

“We en­tered the Re­search Tri­an­gle mar­ket in 1998, we are in­cred­i­bly proud to­day of our po­si­tion at the van­guard of the life sci­ence ecosys­tem that is lead­ing the in­te­gra­tion of R&D with next-gen man­u­fac­tur­ing for com­plex med­i­cines.” said founder Joel Mar­cus. “Through Alexan­dria’s mis­sion-crit­i­cal in­fra­struc­ture, we are en­abling rev­o­lu­tion­ary gene ther­a­py com­pa­nies to pro­duce their med­i­cines in-house and there­by in­crease their con­trol over their qual­i­ty, sup­ply chains and tal­ent with­in the Unit­ed States.”

With the sale of Flori­da site, Ar­ran­ta fo­cus­es mR­NA pro­duc­tion in MA

Mass­a­chu­setts CD­MO Ar­ran­ta Bio has com­plet­ed the sale of a GMP clin­i­cal man­u­fac­tur­ing site in Gainesville, FL, and trans­ferred its client pro­grams and key em­ploy­ees to the Wa­ter­town fa­cil­i­ty, the com­pa­ny said Mon­day.

In­cep­tor Bio is the new own­er of the site about four miles north of the Uni­ver­si­ty of Flori­da cam­pus. The Wa­ter­town site will now have more than 160 em­ploy­ees fo­cused on sup­port­ing mi­cro­bio­me clients, man­u­fac­tur­ing crit­i­cal start­ing ma­te­ri­als and es­tab­lish­ing mR­NA vac­cine ca­pa­bil­i­ties. Its al­so prgress­ing its end-to-end mR­NA ca­pa­bil­i­ties, and will launch a ro­bot­ic ster­ile fill line by the end of Q2 2o22.

“We are de­light­ed that In­cep­tor Bio will build on the foun­da­tion that we es­tab­lished in Gainesville and wish them every suc­cess in de­vel­op­ing life-sav­ing cell ther­a­py prod­ucts,” CEO Mark Bam­forth said in a press re­lease. “And we are thrilled to con­tin­ue to build and ex­pand Ar­ran­ta’s com­mer­cial-ready man­u­fac­tur­ing team in Mass­a­chu­setts, the glob­al hub for bio­sciences.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.