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.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.