Fu­ji­film Diosynth adds on at its NC hub, bol­ster­ing lab space with plans to bring on 145 new jobs

New year, same Fu­ji­film Diosynth.

The CD­MO gi­ant hit the ground run­ning at full speed this year, an­nounc­ing it will ex­pand its Bio­Process In­no­va­tion Cen­ter in Re­search Tri­an­gle Park, NC. The move will dou­ble its ex­ist­ing lab­o­ra­to­ry foot­print in the Tar Heel State, and add an­oth­er 145 skilled jobs to the site by 2024. An­oth­er 89,000 square feet will be added, which will al­low for a more ro­bust com­mer­cial process.

The ex­pan­sion will al­so sup­port its process char­ac­ter­i­za­tion pro­grams, and com­ple­ment op­er­a­tions at its UK fa­cil­i­ty. It’s ex­pect­ed to be op­er­a­tional by 2024.

“As lead­ers in process de­vel­op­ment, we are de­light­ed to be adding this ad­di­tion­al ca­pac­i­ty to sup­port our grow­ing pipeline of cus­tomers,” the site’s COO Chris­tine Van­nais said in a state­ment. “The cut­ting-edge lab­o­ra­to­ry equip­ment and au­toma­tion tools, com­bined with the deep tech­ni­cal ex­per­tise of our sci­en­tif­ic com­mu­ni­ty will al­low us to bet­ter serve our part­ners to rapid­ly gen­er­ate and as­sess da­ta to un­der­stand com­plex mol­e­cules, along with the process­es used in their man­u­fac­ture.”

The BIC opened in May 2016 as a three-sto­ry, 62,000-square-foot fa­cil­i­ty for process in­ven­tion, de­sign and de­vel­op­ment.

The up­grade is big news for the re­gion as two de­vel­op­ers just an­nounced plans for a $1 bil­lion biotech hub in near­by Mor­risville, with enough space for both man­u­fac­tur­ing and R&D work. That site will have re­tail space and out­door recre­ation ar­eas. No fu­ture ten­ants have been named yet so far.

Three weeks ago, the com­pa­ny an­nounced that it would in­vest an­oth­er $300 mil­lion in­to its Bryan-Col­lege Sta­tion, TX fa­cil­i­ty, a move that will cre­ate an­oth­er 150 jobs. That in­vest­ment will fea­ture a $1.5 mil­lion grant from the Texas En­ter­prise Fund. The ex­pan­sion will add 138,000 square feet to the cam­pus and sev­er­al 500- and 2,000-liter biore­ac­tors.

In the fall, Fu­ji­film Diosynth dumped $2 bil­lion in­to a head­quar­ters in North Car­oli­na and an­oth­er $454 mil­lion in its UK sup­ply chain. The project will re­sult in the large-scale cell cul­ture man­u­fac­tur­ing of bulk drug sub­stance. The site will have eight 20,000-liter biore­ac­tors, and the po­ten­tial to add an­oth­er 24.

CPhI ex­perts pre­dict­ed in the fall that CMOs will ac­count for four of the top five man­u­fac­tur­ing ca­pac­i­ties by the year 2025, and near­ly half of all ca­pac­i­ty will shift to large ca­pac­i­ty vol­ume. Fu­ji­film is right at the top of that list, along­side Lon­za, Sam­sung Bi­o­log­ics and WuXi Bi­o­log­ics.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.