A Philadel­phia-based CD­MO will drop $100 mil­lion in­to its asep­tic liq­uid fill-fin­ish and ster­ile lyophiliza­tion tech­nol­o­gy at its re­cent­ly-ac­quired Bed­ford, NH cam­pus.

PCI Phar­ma bought the Lyophiliza­tion Ser­vices of that New Eng­land site at the end of 2021. The new ex­pan­sion will add a 50,000 square-foot fa­cil­i­ty that fea­tures a fill-fin­ish line with a ful­ly iso­lat­ed con­tain­ment sys­tem. It will have the ca­pac­i­ty to fill 400 vials per minute, which will help PCI up its speed and get ther­a­pies to pa­tients quick­er.

The an­nounce­ment is the lat­est in a string of moves across the world. It has ex­pand­ed lo­ca­tions in Rock­ford, IL; San Diego; Mel­bourne, Aus­tralia and Berlin in re­cent years. The com­pa­ny will al­so in­crease ca­pac­i­ty at sites in Spain and Wis­con­sin soon, the press re­lease said.

“We are ex­cit­ed to in­tro­duce clients to our newest fa­cil­i­ty, which is part of our broad­er strat­e­gy to pro­vide in­te­grat­ed end-to-end drug de­vel­op­ment, man­u­fac­tur­ing and pack­ag­ing ca­pa­bil­i­ties,” CEO Sal­im Haf­far said in a state­ment. “Our in­vest­ment in these fa­cil­i­ties will en­sure that PCI con­tin­ues to lever­age new ca­pa­bil­i­ties in com­plex for­mu­la­tions, asep­tic fill-fin­ish, and lyophiliza­tion to meet the needs of our glob­al clients, par­tic­u­lar­ly as bi­o­log­ics con­tin­ue their strong growth tra­jec­to­ry.”

Just in No­vem­ber 2021, PCI an­nounced the con­struc­tion of a new clin­i­cal cen­ter of ex­cel­lence in Bridge­wa­ter, MA, just 25 miles south of Boston. The in­vest­ment al­lows for PCI to be clos­er to clients in the tri-state area, as well as just down the high­way from some of the biggest phar­mas in the world. That cen­ter is sched­uled to be com­plet­ed this sum­mer, and will al­so add 50,000 square feet of op­er­at­ing space to its ar­se­nal.

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.