Ther­mo Fish­er aims to boost its clin­i­cal of­fer­ings with Ger­man ex­pan­sion — in­clud­ing cold chain for the Covid-19 ef­fort

Just days af­ter an­nounc­ing wide-rang­ing ex­pan­sions at four fa­cil­i­ties in the US and Eu­rope, man­u­fac­tur­ing gi­ant Ther­mo Fish­er isn’t slow­ing down. Aim­ing to ramp up its clin­i­cal sup­ply chain of­fer­ings — par­tic­u­lar­ly to aid the Covid-19 re­sponse ef­fort — the CD­MO is spread­ing out in Ger­many with two new fa­cil­i­ties.

Ther­mo has two new fa­cil­i­ties in Rhe­in­felden and Weil am Rhein, Ger­many, go­ing on­line this month and next, re­spec­tive­ly. Like the four re­cent­ly an­nounced site ex­pan­sions, Ther­mo is keep­ing the cost close to the chest.

The new fa­cil­i­ties, the com­pa­ny said, will bring “much-need­ed clin­i­cal sup­ply chain con­ti­nu­ity,” name­ly in spe­cial­ized cold-chain and cryo­genic ex­per­tise across Eu­rope and glob­al­ly. That fo­cus, com­bined with last week’s an­nounced ex­pan­sions fo­cused in part on vac­cine de­vel­op­ment ca­pa­bil­i­ties, un­der­scores Ther­mo’s ever-grow­ing mar­ket for vi­able and ster­ile vac­cine pro­duc­tion, even out­side of the cur­rent break­neck ef­forts to pro­duce a Covid-19 vac­cine.

Ther­mo’s Rhe­in­felden site, open­ing this month, con­sists of an 86,000-square-foot fa­cil­i­ty that will in­crease the com­pa­ny’s foot­print for sec­ondary pack­ag­ing, stor­age, lo­gis­tics and dis­tri­b­u­tion of clin­i­cal sup­plies to in­ves­ti­ga­tor sites across Eu­rope, the com­pa­ny said in a news re­lease.

A 9,600-square-foot cry­ocen­ter high­lights the Weil am Rhein fa­cil­i­ty and will al­low for spe­cial­ized ul­tra-low-tem­per­a­ture, cryo­genic stor­age and cold-chain ex­per­tise for clin­i­cal-sup­ply chain needs for cell and gene ther­a­pies, in­clud­ing Covid-19 vac­cine can­di­dates, Ther­mo said. The site will fea­ture -80 de­gree Cel­sius freez­ers, liq­uid ni­tro­gen cryo­genic stor­age tanks and walk-in 2-8 de­grees Cel­sius and -20 de­grees Cel­sius cold stor­age tech­nol­o­gy. That fa­cil­i­ty is set to open in Jan­u­ary.

The Mass­a­chu­setts com­pa­ny late last week un­veiled ex­pan­sion projects at its fa­cil­i­ties in Greenville, NC; Fer­enti­no and Mon­za, Italy; and Swin­don, Eng­land, to widen the range of op­tions avail­able to its cus­tomers, sig­nal­ing a suc­cess­ful run for the com­pa­ny in a high-paced year for con­tract man­u­fac­tur­ers.

In ad­di­tion to the four pro­duc­tion site ex­pan­sions and the new sup­ply-chain ad­di­tions, Ther­mo al­so re­cent­ly an­nounced an ex­pan­sion in Sin­ga­pore that in­cludes a high-speed ster­ile line for live-virus fill­ing. The com­pa­ny al­so agreed to a joint ven­ture with In­no­force to build a new phar­ma­ceu­ti­cal ser­vices fa­cil­i­ty in Hangzhou, Chi­na that fo­cus­es on in­te­grat­ed bi­o­log­ics drug sub­stance and ster­ile drug prod­uct de­vel­op­ment and man­u­fac­tur­ing.

Both of those sites are ex­pect­ed to be com­plet­ed in 2022.

“These fa­cil­i­ties, com­bined with our es­tab­lished reg­u­la­to­ry ex­per­tise, will give cus­tomers the con­ti­nu­ity and in-re­gion ca­pa­bil­i­ties to sup­port clin­i­cal tri­als across mul­ti­ple ther­a­py ar­eas,” said Mike Shafer, Ther­mo Fish­er’s SVP and pres­i­dent of phar­ma ser­vices. “Ul­ti­mate­ly, we are en­abling our cus­tomers to make the world health­i­er by bring­ing new med­i­cines to pa­tients with ex­cep­tion­al speed, ef­fi­cien­cy and qual­i­ty.”

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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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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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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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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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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