Ire­land has been on a roll in 2022, with sev­er­al large phar­ma com­pa­nies an­nounc­ing mul­ti­mil­lion-eu­ro projects. Now As­traZeneca’s rare dis­ease out­fit Alex­ion is look­ing to get in on the ac­tion.

Alex­ion on Fri­day an­nounced a €65 mil­lion ($68.8 mil­lion) in­vest­ment in new and en­hanced ca­pa­bil­i­ties across two sites in the coun­try, in­clud­ing at Col­lege Park in the Dublin sub­urb of Blan­chard­stown and the Monksland In­dus­tri­al Park in the cen­tral Irish town of Athlone, ac­cord­ing to the In­dus­tri­al De­vel­op­ment Agency of Ire­land.

The project can be bro­ken down in­to three in­vest­ments in­clud­ing the in­stal­la­tion of new drug sub­stance pro­duc­tion equip­ment and ware­hous­ing fa­cil­i­ties to sup­port am­bi­ent and cold stor­age at Col­lege Park and Athlone, and the con­struc­tion of a man­u­fac­tur­ing sci­ences and tech­nol­o­gy lab at Col­lege Park.

“The equip­ment and ware­house fa­cil­i­ty in each site will ex­pand Alex­ion’s drug sub­stance pro­duc­tion ca­pa­bil­i­ties in Ire­land,” IDA Ire­land stat­ed.

The scale-up of bi­o­log­ics man­u­fac­tur­ing ca­pa­bil­i­ty and R&D ex­pan­sion at these two sites will oc­cur over the next 18 months, ac­cord­ing to a state­ment Alex­ion emailed to End­points News. Ap­prox­i­mate­ly 1,000 peo­ple work across both sites and the ex­pan­sion will add a small num­ber of jobs, though no sol­id num­bers were giv­en.

For the Alex­ion Man­u­fac­tur­ing Sci­ences & Tech­nol­o­gy Lab at Col­lege Park, the in­vest­ment will seek to fa­cil­i­tate the scal­ing up of bi­o­log­ics drug sub­stance man­u­fac­tur­ing in Ire­land, al­though de­tails on the con­struc­tion were not im­me­di­ate­ly avail­able to End­points.

“This in­vest­ment will al­low for new ca­pa­bil­i­ties for As­traZeneca in Ire­land and sup­port our glob­al am­bi­tion to ac­cel­er­ate the de­vel­op­ment and de­liv­ery of life-chang­ing med­i­cines for more peo­ple af­fect­ed by rare dis­eases,” Alex­ion CEO Marc Dunoy­er said in a state­ment.

Col­lege Park has been a hot spot for both Alex­ion and As­traZeneca. In 2021, the Big Phar­ma shelled out $360 mil­lion to build an API plant for small mol­e­cules at its Alex­ion cam­pus in Col­lege Park, Dublin, fo­cus­ing on late-stage de­vel­op­ment and ear­ly com­mer­cial sup­ply for small mol­e­cule ther­a­pies.

As Alex­ion com­mits to Ire­land, the com­pa­ny finds it­self among an ever-grow­ing crowd of man­u­fac­tur­ers. In Feb­ru­ary, Eli Lil­ly an­nounced it would pump al­most $1.5 bil­lion in­to two new man­u­fac­tur­ing fa­cil­i­ties. Mer­ck KGaA an­nounced in May it was mak­ing a €440 mil­lion ($470 mil­lion) in­vest­ment to in­crease mem­brane man­u­fac­tur­ing ca­pac­i­ty in Car­rigt­wohill, Ire­land, and build a new man­u­fac­tur­ing fa­cil­i­ty at Blar­ney Busi­ness Park, in Coun­ty Cork, Ire­land.

Most re­cent­ly, New Jer­sey-based CD­MO Cam­brex ac­quired Q1 Sci­en­tif­ic, a provider of en­vi­ron­men­tal­ly con­trolled cGMP sta­bil­i­ty stor­age ser­vices, lo­cat­ed in the city of Wa­ter­ford, Ire­land.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

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, less than two weeks after its supplemental BLA was accepted. 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.

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

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.

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.”