Fu­ji­film boosts man­u­fac­tur­ing ca­pac­i­ty along­side R&D; Bax­ter In­ter­na­tion­al will in­vest $100M in Bio­Phar­ma So­lu­tions

Fu­ji­film Irvine Sci­en­tif­ic is ex­pand­ing an R&D cen­ter in Cal­i­for­nia, and it’s boost­ing its man­u­fac­tur­ing along with it.

The com­pa­ny an­nounced Wednes­day that it would ex­pand its Arm­strong R&D Cen­ter of Ex­cel­lence at head­quar­ters in San­ta Ana, in or­der to com­mit to the ad­vance­ment of dis­cov­ery re­search, bio­pro­duc­tion, and cell and gene ther­a­py among oth­er things. But as its ex­pe­ri­enced a sig­nif­i­cant amount of rev­enue in­crease in the past year, and boast­ing of new man­u­fac­tur­ing ca­pa­bil­i­ties in Eu­rope, the ex­pan­sion will help aid those ef­forts.

In a state­ment, CSO Bob New­man said:

“With so­ci­ety’s in­creas­ing de­mand for glob­al ac­cess to more high-qual­i­ty, cost-ef­fec­tive vac­cines, bio­phar­ma­ceu­ti­cals, cell-based ther­a­pies, gene ther­a­pies, and in-vit­ro fer­til­iza­tion pro­ce­dures, the need for a broad­ened fo­cus on in­no­va­tion is piv­otal to ex­pe­dite crit­i­cal prod­uct and tech­nol­o­gy de­vel­op­ment. The ex­pan­sion project will more than dou­ble the R&D fa­cil­i­ty’s foot­print and will al­low for more en­hanced tech­ni­cal col­lab­o­ra­tion be­tween R&D ex­perts and cus­tomers to de­vel­op per­son­al­ized so­lu­tions and en­hance part­ner­ship op­por­tu­ni­ties.”

Bax­ter In­ter­na­tion­al will in­vest $100M in Bio­Phar­ma So­lu­tions

An Illi­nois man­u­fac­tur­er is get­ting a boost at its Ger­man site.

Bio­Phar­ma So­lu­tions has land­ed a $100 mil­lion in­vest­ment from Bax­ter In­ter­na­tion­al to ex­pand its ster­ile fill-fin­ish man­u­fac­tur­ing fa­cil­i­ty in Halle/West­falen. Con­struc­tion is set to start in 2022, and wrap up in 2024, and will help ex­pand the com­pa­ny’s foot­print, while adding an asep­tic sy­ringe fill­ing line to meet de­mand for the prod­uct both in the US and Eu­rope.

“Bax­ter’s man­u­fac­tur­ing site in Halle/West­falen is one of the most ad­vanced fa­cil­i­ties in our glob­al net­work and has seen sig­nif­i­cant growth over the last sev­er­al years,” Bax­ter Bio­Phar­ma So­lu­tions Gen­er­al Man­ag­er Marie Kee­ley said. “By mak­ing this in­vest­ment, we are build­ing on re­cent ex­pan­sions to help en­sure this fa­cil­i­ty can serve our part­ners at the high­est lev­el now and well in­to the fu­ture.”

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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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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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.

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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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.

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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