Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fu­ji­film’s spend­ing spree in­to its CD­MO arm is not slow­ing down.

The multi­na­tion­al an­nounced on Wednes­day that it will in­vest $1.6 bil­lion to en­hance and ex­pand the cell cul­ture man­u­fac­tur­ing ser­vices of the CD­MO arm of the Japan­ese con­glom­er­ate Fu­ji­film Diosynth.

The in­vest­ment will en­hance Fu­ji­film Diosynth Biotech­nolo­gies’ sites in Hillerød, Den­mark, and Col­lege Sta­tion, TX. The in­vest­ment is ex­pect­ed to cre­ate ap­prox­i­mate­ly 450 jobs across both fa­cil­i­ties.

Mar­tin Mee­son

“Fu­ji­film Diosynth Biotech­nolo­gies will glob­al­ly ac­cel­er­ate the de­ploy­ment of its ful­ly in­te­grat­ed con­tin­u­ous cGMP pro­duc­tion ca­pa­bil­i­ty to en­able ef­fi­cient man­u­fac­ture of an­ti­bod­ies at a high vol­ume,” Fu­ji­film Diosynth CEO Mar­tin Mee­son said in a state­ment.

Ac­cord­ing to the com­pa­ny, it is fur­ther ex­pand­ing its ca­pac­i­ty to sup­port large-scale cGMP-fed batch pro­duc­tion by adding eight 20,000-liter biore­ac­tors and two down­stream pro­cess­ing streams at its Hillerød fa­cil­i­ty. The ad­di­tion­al pro­duc­tion ca­pac­i­ty will make Hillerød one of the largest end-to-end CD­MO fa­cil­i­ties in Eu­rope. The up­grades will of­fer a to­tal of 20 20,000-liter biore­ac­tors for drug sub­stance pro­duc­tion com­ple­ment­ed by com­pre­hen­sive drug prod­ucts and fin­ished goods ser­vices.

For their site in the Lone Star State, the in­vest­ment will ex­pand cell cul­ture man­u­fac­tur­ing so­lu­tions by mak­ing use of their Sym­phonX and MaruX plat­forms to en­able con­tin­u­ous pro­cess­ing.

Fu­ji­film has been in­vest­ing heav­i­ly in the CD­MO branch, es­pe­cial­ly in the Unit­ed States.

In March of 2021, the com­pa­ny se­lect­ed Hol­ly Springs, NC, as the site of its $2 bil­lion cell cul­ture su­per­plant, adding 725 jobs in the area by 2028. The plants will look to come on­line in 2025 and house eight 20,000-liter biore­ac­tors with the po­ten­tial to ex­pand and add a fur­ther 24 biore­ac­tors of the same size.

Ear­li­er this year, the CD­MO gi­ant hit the ground run­ning with the ex­pan­sion of its Bio­Process In­no­va­tion Cen­ter in Re­search Tri­an­gle Park, NC, adding on an­oth­er 89,000 square feet. And as part of a $100 mil­lion deal, the com­pa­ny ac­quired a 90,000-square feet man­u­fac­tur­ing site from Atara Bio­ther­a­peu­tics in Thou­sand Oaks, CA.

Al­so in 2021, the Japan­ese con­glom­er­ate pumped $850 mil­lion in­to lo­ca­tions in the US and UK. The com­pa­ny sought to in­crease its gene ther­a­py ca­pac­i­ty in the UK by 10-fold. These two ex­pan­sions will start in 2023.

This al­so comes at a time when oth­er man­u­fac­tur­ers based in Asia, in­clud­ing the South Ko­re­an gi­ants of SK, Sam­sung and Lotte, are mak­ing or are look­ing to make no­table in­vest­ments and ac­qui­si­tions in Eu­rope and the US to boost their man­u­fac­tur­ing ca­pa­bil­i­ties.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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