Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Pfiz­er to make ma­jor in­vest­ment in vac­cine R&D and man­u­fac­tur­ing site in New York

It’s been just over a month since Pfiz­er an­nounced it was pump­ing $120 mil­lion in­to its Michi­gan fa­cil­i­ty to boost Paxlovid pro­duc­tion, and now the Big Phar­ma is mak­ing an­oth­er ma­jor in­vest­ment in vac­cine man­u­fac­tur­ing, this time in its fa­cil­i­ty out­side New York City.

Ac­cord­ing to a re­port from Bloomberg, Pfiz­er is look­ing to sink $470 mil­lion in­to ex­pand­ing its vac­cine re­search fa­cil­i­ties at its lo­ca­tion in Pearl Riv­er, NY, just 25 miles north of New York City. Pfiz­er will con­struct a new build­ing as well as ren­o­vate ex­ist­ing fa­cil­i­ties on the cam­pus. The to­tal ex­pan­sion will be 260,000 square feet with an ad­di­tion­al 55,000 square feet of lab space. The com­pa­ny is aim­ing for con­struc­tion in the first quar­ter of 2026, the re­port said.

Ac­cord­ing to the com­pa­ny, the Pearl Riv­er lo­ca­tion has been a hub for its vac­cine R&D and was key in the part­ner­ship with BioN­Tech that re­sult­ed in their his­toric Covid-19 vac­cine. The re­search for Pre­vnar 13 and Tru­men­ba was al­so con­duct­ed there, as well as the man­u­fac­ture of its an­ti­body-drug con­ju­gates.

The 330-acre site al­so has more than 800 em­ploy­ees.

An ex­pan­sion at Pearl Riv­er has been on CEO Al­bert Bourla’s mind for a while now.

In an in­ter­view with the Wall Street Jour­nal in 2021, he ini­tial­ly planned to grow the R&D team there by at least 50.

Bloomberg al­so not­ed that Pfiz­er had re­cent­ly made a sep­a­rate $29 mil­lion in­vest­ment to es­tab­lish a lab in Pearl Riv­er to study dan­ger­ous in­fec­tious agents.

This al­so comes at a time when Pfiz­er placed a large in­vest­ment in­to its 1,300-acre man­u­fac­tur­ing fa­cil­i­ty in Kala­ma­zoo to en­able US-based pro­duc­tion in sup­port of its Covid-19 oral an­tivi­ral. The in­vest­ment ex­pand­ed the pro­duc­tion of the API and RSMs used in the man­u­fac­ture of nir­ma­trelvir, a key com­po­nent in Paxlovid, and opened up around 250 jobs.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

A cell therapy outfit in California that manufactures a human umbilical cord derived cellular product and exosome products is facing a warning from the FDA over several major observations related to quality.

The FDA notes the site’s “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing,” and the “risk that your products may be contaminated with microorganisms or have other serious product quality defects.”