Large plas­ma com­pa­nies CSL Behring and Gri­fols re­cent­ly sued US Cus­toms and Bor­der Pa­trol, which last sum­mer stopped al­low­ing Mex­i­can cit­i­zens from cross­ing in­to the US on tem­po­rary visas to sell their blood plas­ma.

The ban, ac­cord­ing to the Aus­tralia- and Spain-based com­pa­nies, is based “sole­ly on CBP’s new­found de­ter­mi­na­tion that do­nat­ing plas­ma is some­how ‘la­bor for hire,'” and it means that there may be plas­ma short­ages, ac­cord­ing to the suit re-filed in DC Dis­trict Court. The com­pa­nies pre­vi­ous­ly lost a pri­or suit last year as the judge dis­missed their com­plaint for lack of stand­ing.

CSL op­er­ates a net­work of 15 plas­ma col­lec­tion cen­ters near the south­ern bor­der in Texas and Ari­zona, with plans to open two more cen­ters short­ly, in­clud­ing its first on the Cal­i­for­nia bor­der. Gri­fols, mean­while, op­er­ates 24 such cen­ters in Ari­zona, Texas and Cal­i­for­nia, ac­cord­ing to the suit. The com­pa­nies es­ti­mate that these cross-bor­der do­na­tions are re­spon­si­ble for about 5-10% of all US plas­ma col­lec­tions.

“Such a dis­rup­tion in plas­ma do­na­tions is es­pe­cial­ly crit­i­cal now, when more plas­ma than ever is re­quired to meet the grow­ing need for plas­ma-based ther­a­pies, and when the Unit­ed States has al­ready suf­fered a 20% in­dus­try-wide drop in do­na­tions due to the pan­dem­ic,” the suit says.

The com­pa­nies claim that CBP “need­less­ly pulled the rug out from un­der plas­ma in­dus­try donors and em­ploy­ees as well as the pa­tients” as plas­ma is a cru­cial in­gre­di­ent for some treat­ments for se­ri­ous dis­eases that af­fect more than 125,000 Amer­i­cans, in­clud­ing pri­ma­ry and sec­ondary im­mune de­fi­cien­cies, res­pi­ra­to­ry dis­eases, neu­ro­log­i­cal dis­or­ders, and he­mo­phil­ia and oth­er blood dis­or­ders.

“For in­stance, im­munoglob­u­lin ther­a­py for a sin­gle pa­tient suf­fer­ing from one of a host of pri­ma­ry and sec­ondary im­mune de­fi­cien­cies re­quires about 130 do­na­tions of plas­ma an­nu­al­ly, and a year of ther­a­py for a sin­gle he­mo­phil­ia pa­tient re­quires about 1,200 do­na­tions,” the suit says.

But since last June, CBP has de­cid­ed that 30 years of prece­dent should be over­turned, and the agency sent back all po­ten­tial donors from Mex­i­co, claim­ing the do­na­tions are part of this “la­bor for hire” op­er­a­tion.

The com­pa­nies, how­ev­er, claim that the fact that a donor re­ceives pay­ment as part of the do­na­tion process “is in­ci­den­tal to the ser­vice trans­ac­tion and does not some­how trans­form the re­la­tion­ship in­to any­thing ‘akin to em­ploy­ment or con­tract work.'”

Ac­cord­ing to ProP­ub­li­ca, be­fore the pan­dem­ic, donors could make about $4,000 an­nu­al­ly if they do­nat­ed as of­ten as pos­si­ble. US law al­lows for 96 do­na­tions per year, where­as Eu­ro­pean law al­lows for 33 do­na­tions per year. Since the pan­dem­ic, those prices have gone up as do­na­tions be­come more scarce.

The ban has had a par­tic­u­lar­ly out­sized ef­fect on sev­er­al of the plain­tiffs, in­clud­ing Kevin Ras­mussen, who is a reg­u­lar plas­ma donor at CSL Plas­ma’s cen­ter in Dou­glas, AZ. He do­nates plas­ma about eight times per month, the max­i­mum per­mit­ted by FDA reg­u­la­tions, in or­der to help sup­port his fam­i­ly and wife, who has a chron­ic health con­di­tion and is of­ten un­able to work, the suit says.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

Catalent is opening the doors to a new plasmid DNA manufacturing site at one of its core sites in Europe.

The new 12,000-square-foot plasmid manufacturing site is located in its cell therapy center in Gosselies, Belgium, and has multiple cleanrooms meant to produce cGMP-grade plasmid DNA for clinical and commercial purposes. The site will also see Catalent producing plasmids that are intended to be used by cell and gene companies.